Trial Outcomes & Findings for SURGICEL® Powder in Controlling Mild or Moderate Parenchymal or Soft Tissue Intraoperative Bleeding in Adult Subjects (NCT NCT03762200)

Last Updated: 2021-07-26

Results Overview

Proportion of subjects achieving haemostatic success at 5 minutes following application of SURGICEL Powder with no rebleeding requiring additional treatment at the Target Bleeding Site (TBS) any time prior to initiation of final fascial closure

Recruitment status

COMPLETED

Study phase

Target enrollment

103 participants

Primary outcome timeframe

From application of SURGICEL Powder to 5 minutes after application

Results posted on

2021-07-26

Participant Flow

Subjects were screened up to 21 days prior to surgery and attended a baseline visit within 24 hours of surgery. Both visits took place at a clinic within the hospital where surgery also took place. Subjects were followed until hospital discharge and requested to attend a visit at 30 (+14) days post surgery and at 6 months (+/- 30 days) either at the hospital or via telephone.

Subjects required to meet pre-defined inclusion/exclusion criteria prior to receiving study product. Subjects required to have an appropriate mild or moderate target bleeding site (TBS) identified intra-operatively. Subjects excluded if the TBS was where silver nitrate or any other escharotic chemicals were applied, was in, around, or in proximity to foramina in bone, areas of bony confine or where plugging of the urethra, ureter or a catheter was possible by study product.

Participant milestones

Participant milestones
Measure	SURGICEL Powder Absorbable Haemostatic Powder (Oxidized Regenerated Cellulose)
Overall Study STARTED	103
Overall Study COMPLETED	101
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	SURGICEL Powder Absorbable Haemostatic Powder (Oxidized Regenerated Cellulose)
Overall Study Death	2

Baseline Characteristics

SURGICEL® Powder in Controlling Mild or Moderate Parenchymal or Soft Tissue Intraoperative Bleeding in Adult Subjects

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	SURGICEL Powder n=103 Participants Absorbable Haemostatic Powder (Oxidized Regenerated Cellulose)
Age, Continuous Age at Consent	64.0 Years n=5 Participants
Sex: Female, Male Female	51 Participants n=5 Participants
Sex: Female, Male Male	52 Participants n=5 Participants
Race/Ethnicity, Customized Race : White	93 Participants n=5 Participants
Race/Ethnicity, Customized Race : Asian	2 Participants n=5 Participants
Race/Ethnicity, Customized Race : Not Reported	8 Participants n=5 Participants

PRIMARY outcome

Timeframe: From application of SURGICEL Powder to 5 minutes after application

Population: Intent to Treat (All subjects for whom TBS was identified)

Outcome measures

Outcome measures
Measure	SURGICEL Powder n=103 Participants Absorbable Haemostatic Powder (Oxidized Regenerated Cellulose)
Haemostatic Success at 5 Minutes	90 Participants

SECONDARY outcome

Timeframe: From application of SURGICEL Powder to 3 minutes after application

Proportion of subjects achieving haemostatic success at 3 minutes following application of SURGICEL Powder with no rebleeding requiring additional treatment at the TBS any time prior to initiation of final fascial closure

Outcome measures

Outcome measures
Measure	SURGICEL Powder n=103 Participants Absorbable Haemostatic Powder (Oxidized Regenerated Cellulose)
Haemostatic Success at 3 Minutes	80 Participants

SECONDARY outcome

Timeframe: From application of SURGICEL Powder to 10 minutes after application

Proportion of subjects achieving haemostatic success at 10 minutes following the application of SURGICEL Powder with no rebleeding that requires additional treatment at the TBS any time prior to initiation of final fascial closure

Outcome measures

Outcome measures
Measure	SURGICEL Powder n=103 Participants Absorbable Haemostatic Powder (Oxidized Regenerated Cellulose)
Haemostatic Success at 10 Minutes	95 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: From application of SURGICEL Powder to 30 day follow-up visit

Number of participants experiencing a thromboembolic event that was assessed as having either an unlikely, possible, probable or causal relationship to the study treatment

Outcome measures

Outcome measures
Measure	SURGICEL Powder n=103 Participants Absorbable Haemostatic Powder (Oxidized Regenerated Cellulose)
Number of Participants Experiencing a Thromboembolic Event	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: From initiation of final fascial closure to the 30-day follow up visit

Number of participants of post-operative re-bleeding that was assessed as having either an unlikely, possible, probable or causal relationship to the TBS and requiring medical/surgical intervention

Outcome measures

Outcome measures
Measure	SURGICEL Powder n=103 Participants Absorbable Haemostatic Powder (Oxidized Regenerated Cellulose)
Number of Participants With Post-operative Re-bleeding	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: From time of SURGICEL Powder application to 6-month follow up visit

Number of participants experiencing a serious adverse event requiring surgical intervention and assessed as having either an unlikely, possible, probable or causal relationship to the study treatment

Outcome measures

Outcome measures
Measure	SURGICEL Powder n=103 Participants Absorbable Haemostatic Powder (Oxidized Regenerated Cellulose)
Number of Participants Experiencing a Serious Adverse Events Requiring Surgical Intervention and Related to SURGICEL Powder	0 Participants

Adverse Events

SURGICEL Powder

Serious events: 24 serious events

Other events: 63 other events

Deaths: 2 deaths

Serious adverse events

Serious adverse events
Measure	SURGICEL Powder n=103 participants at risk Absorbable Haemostatic Powder (Oxidized Regenerated Cellulose)
Investigations Heart rate irregular	0.97% 1/103 • Number of events 1 • Adverse events were collected from time product applied to TBS and up to 30 (+14) day follow-up visit. From initiation of final fascial closure to 6-month follow-up visit, SAEs requiring surgical intervention and assessed as having either an unlikely, possible, probable or causal relationship to the study treatment were recorded. For this study, an AE is an untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.
Gastrointestinal disorders Abdominal hernia	0.97% 1/103 • Number of events 1 • Adverse events were collected from time product applied to TBS and up to 30 (+14) day follow-up visit. From initiation of final fascial closure to 6-month follow-up visit, SAEs requiring surgical intervention and assessed as having either an unlikely, possible, probable or causal relationship to the study treatment were recorded. For this study, an AE is an untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.
Gastrointestinal disorders Constipation	0.97% 1/103 • Number of events 1 • Adverse events were collected from time product applied to TBS and up to 30 (+14) day follow-up visit. From initiation of final fascial closure to 6-month follow-up visit, SAEs requiring surgical intervention and assessed as having either an unlikely, possible, probable or causal relationship to the study treatment were recorded. For this study, an AE is an untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.
Gastrointestinal disorders Gastroduodenal haemorrhage	0.97% 1/103 • Number of events 1 • Adverse events were collected from time product applied to TBS and up to 30 (+14) day follow-up visit. From initiation of final fascial closure to 6-month follow-up visit, SAEs requiring surgical intervention and assessed as having either an unlikely, possible, probable or causal relationship to the study treatment were recorded. For this study, an AE is an untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.
Gastrointestinal disorders Ileus	0.97% 1/103 • Number of events 1 • Adverse events were collected from time product applied to TBS and up to 30 (+14) day follow-up visit. From initiation of final fascial closure to 6-month follow-up visit, SAEs requiring surgical intervention and assessed as having either an unlikely, possible, probable or causal relationship to the study treatment were recorded. For this study, an AE is an untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.
Gastrointestinal disorders Impaired gastric emptying	0.97% 1/103 • Number of events 1 • Adverse events were collected from time product applied to TBS and up to 30 (+14) day follow-up visit. From initiation of final fascial closure to 6-month follow-up visit, SAEs requiring surgical intervention and assessed as having either an unlikely, possible, probable or causal relationship to the study treatment were recorded. For this study, an AE is an untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.
Gastrointestinal disorders Large intestine perforation	0.97% 1/103 • Number of events 1 • Adverse events were collected from time product applied to TBS and up to 30 (+14) day follow-up visit. From initiation of final fascial closure to 6-month follow-up visit, SAEs requiring surgical intervention and assessed as having either an unlikely, possible, probable or causal relationship to the study treatment were recorded. For this study, an AE is an untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.
Gastrointestinal disorders Pancreatic fistula	0.97% 1/103 • Number of events 1 • Adverse events were collected from time product applied to TBS and up to 30 (+14) day follow-up visit. From initiation of final fascial closure to 6-month follow-up visit, SAEs requiring surgical intervention and assessed as having either an unlikely, possible, probable or causal relationship to the study treatment were recorded. For this study, an AE is an untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.
General disorders Chest pain	0.97% 1/103 • Number of events 1 • Adverse events were collected from time product applied to TBS and up to 30 (+14) day follow-up visit. From initiation of final fascial closure to 6-month follow-up visit, SAEs requiring surgical intervention and assessed as having either an unlikely, possible, probable or causal relationship to the study treatment were recorded. For this study, an AE is an untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.
General disorders Pyrexia	1.9% 2/103 • Number of events 2 • Adverse events were collected from time product applied to TBS and up to 30 (+14) day follow-up visit. From initiation of final fascial closure to 6-month follow-up visit, SAEs requiring surgical intervention and assessed as having either an unlikely, possible, probable or causal relationship to the study treatment were recorded. For this study, an AE is an untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.
Infections and infestations Device related sepsis	0.97% 1/103 • Number of events 1 • Adverse events were collected from time product applied to TBS and up to 30 (+14) day follow-up visit. From initiation of final fascial closure to 6-month follow-up visit, SAEs requiring surgical intervention and assessed as having either an unlikely, possible, probable or causal relationship to the study treatment were recorded. For this study, an AE is an untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.
Infections and infestations Pneumonia	0.97% 1/103 • Number of events 1 • Adverse events were collected from time product applied to TBS and up to 30 (+14) day follow-up visit. From initiation of final fascial closure to 6-month follow-up visit, SAEs requiring surgical intervention and assessed as having either an unlikely, possible, probable or causal relationship to the study treatment were recorded. For this study, an AE is an untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.
Infections and infestations Postoperative wound infection	0.97% 1/103 • Number of events 1 • Adverse events were collected from time product applied to TBS and up to 30 (+14) day follow-up visit. From initiation of final fascial closure to 6-month follow-up visit, SAEs requiring surgical intervention and assessed as having either an unlikely, possible, probable or causal relationship to the study treatment were recorded. For this study, an AE is an untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.
Infections and infestations Sepsis	0.97% 1/103 • Number of events 1 • Adverse events were collected from time product applied to TBS and up to 30 (+14) day follow-up visit. From initiation of final fascial closure to 6-month follow-up visit, SAEs requiring surgical intervention and assessed as having either an unlikely, possible, probable or causal relationship to the study treatment were recorded. For this study, an AE is an untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.
Infections and infestations Urosepsis	0.97% 1/103 • Number of events 1 • Adverse events were collected from time product applied to TBS and up to 30 (+14) day follow-up visit. From initiation of final fascial closure to 6-month follow-up visit, SAEs requiring surgical intervention and assessed as having either an unlikely, possible, probable or causal relationship to the study treatment were recorded. For this study, an AE is an untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.
Infections and infestations Wound infection	0.97% 1/103 • Number of events 1 • Adverse events were collected from time product applied to TBS and up to 30 (+14) day follow-up visit. From initiation of final fascial closure to 6-month follow-up visit, SAEs requiring surgical intervention and assessed as having either an unlikely, possible, probable or causal relationship to the study treatment were recorded. For this study, an AE is an untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.
Injury, poisoning and procedural complications Post procedural bile leak	0.97% 1/103 • Number of events 1 • Adverse events were collected from time product applied to TBS and up to 30 (+14) day follow-up visit. From initiation of final fascial closure to 6-month follow-up visit, SAEs requiring surgical intervention and assessed as having either an unlikely, possible, probable or causal relationship to the study treatment were recorded. For this study, an AE is an untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.
Injury, poisoning and procedural complications Post procedural haematoma	0.97% 1/103 • Number of events 1 • Adverse events were collected from time product applied to TBS and up to 30 (+14) day follow-up visit. From initiation of final fascial closure to 6-month follow-up visit, SAEs requiring surgical intervention and assessed as having either an unlikely, possible, probable or causal relationship to the study treatment were recorded. For this study, an AE is an untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.
Metabolism and nutrition disorders Hyperglycaemia	0.97% 1/103 • Number of events 1 • Adverse events were collected from time product applied to TBS and up to 30 (+14) day follow-up visit. From initiation of final fascial closure to 6-month follow-up visit, SAEs requiring surgical intervention and assessed as having either an unlikely, possible, probable or causal relationship to the study treatment were recorded. For this study, an AE is an untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.97% 1/103 • Number of events 1 • Adverse events were collected from time product applied to TBS and up to 30 (+14) day follow-up visit. From initiation of final fascial closure to 6-month follow-up visit, SAEs requiring surgical intervention and assessed as having either an unlikely, possible, probable or causal relationship to the study treatment were recorded. For this study, an AE is an untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to lung	0.97% 1/103 • Number of events 1 • Adverse events were collected from time product applied to TBS and up to 30 (+14) day follow-up visit. From initiation of final fascial closure to 6-month follow-up visit, SAEs requiring surgical intervention and assessed as having either an unlikely, possible, probable or causal relationship to the study treatment were recorded. For this study, an AE is an untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.
Renal and urinary disorders Acute kidney injury	0.97% 1/103 • Number of events 1 • Adverse events were collected from time product applied to TBS and up to 30 (+14) day follow-up visit. From initiation of final fascial closure to 6-month follow-up visit, SAEs requiring surgical intervention and assessed as having either an unlikely, possible, probable or causal relationship to the study treatment were recorded. For this study, an AE is an untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.97% 1/103 • Number of events 1 • Adverse events were collected from time product applied to TBS and up to 30 (+14) day follow-up visit. From initiation of final fascial closure to 6-month follow-up visit, SAEs requiring surgical intervention and assessed as having either an unlikely, possible, probable or causal relationship to the study treatment were recorded. For this study, an AE is an untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.
Respiratory, thoracic and mediastinal disorders Pleuritic pain	0.97% 1/103 • Number of events 1 • Adverse events were collected from time product applied to TBS and up to 30 (+14) day follow-up visit. From initiation of final fascial closure to 6-month follow-up visit, SAEs requiring surgical intervention and assessed as having either an unlikely, possible, probable or causal relationship to the study treatment were recorded. For this study, an AE is an untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.97% 1/103 • Number of events 1 • Adverse events were collected from time product applied to TBS and up to 30 (+14) day follow-up visit. From initiation of final fascial closure to 6-month follow-up visit, SAEs requiring surgical intervention and assessed as having either an unlikely, possible, probable or causal relationship to the study treatment were recorded. For this study, an AE is an untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.97% 1/103 • Number of events 1 • Adverse events were collected from time product applied to TBS and up to 30 (+14) day follow-up visit. From initiation of final fascial closure to 6-month follow-up visit, SAEs requiring surgical intervention and assessed as having either an unlikely, possible, probable or causal relationship to the study treatment were recorded. For this study, an AE is an untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.
Vascular disorders Haemodynamic instability	0.97% 1/103 • Number of events 1 • Adverse events were collected from time product applied to TBS and up to 30 (+14) day follow-up visit. From initiation of final fascial closure to 6-month follow-up visit, SAEs requiring surgical intervention and assessed as having either an unlikely, possible, probable or causal relationship to the study treatment were recorded. For this study, an AE is an untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.
Vascular disorders Hypertension	0.97% 1/103 • Number of events 1 • Adverse events were collected from time product applied to TBS and up to 30 (+14) day follow-up visit. From initiation of final fascial closure to 6-month follow-up visit, SAEs requiring surgical intervention and assessed as having either an unlikely, possible, probable or causal relationship to the study treatment were recorded. For this study, an AE is an untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.
Vascular disorders Hypotension	0.97% 1/103 • Number of events 1 • Adverse events were collected from time product applied to TBS and up to 30 (+14) day follow-up visit. From initiation of final fascial closure to 6-month follow-up visit, SAEs requiring surgical intervention and assessed as having either an unlikely, possible, probable or causal relationship to the study treatment were recorded. For this study, an AE is an untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.
General disorders Death	0.97% 1/103 • Number of events 1 • Adverse events were collected from time product applied to TBS and up to 30 (+14) day follow-up visit. From initiation of final fascial closure to 6-month follow-up visit, SAEs requiring surgical intervention and assessed as having either an unlikely, possible, probable or causal relationship to the study treatment were recorded. For this study, an AE is an untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic carcinoma metastatic	0.97% 1/103 • Number of events 1 • Adverse events were collected from time product applied to TBS and up to 30 (+14) day follow-up visit. From initiation of final fascial closure to 6-month follow-up visit, SAEs requiring surgical intervention and assessed as having either an unlikely, possible, probable or causal relationship to the study treatment were recorded. For this study, an AE is an untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.
Blood and lymphatic system disorders Lymphadenitis	0.97% 1/103 • Number of events 1 • Adverse events were collected from time product applied to TBS and up to 30 (+14) day follow-up visit. From initiation of final fascial closure to 6-month follow-up visit, SAEs requiring surgical intervention and assessed as having either an unlikely, possible, probable or causal relationship to the study treatment were recorded. For this study, an AE is an untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.

Other adverse events

Other adverse events
Measure	SURGICEL Powder n=103 participants at risk Absorbable Haemostatic Powder (Oxidized Regenerated Cellulose)
Blood and lymphatic system disorders Anaemia	1.9% 2/103 • Number of events 2 • Adverse events were collected from time product applied to TBS and up to 30 (+14) day follow-up visit. From initiation of final fascial closure to 6-month follow-up visit, SAEs requiring surgical intervention and assessed as having either an unlikely, possible, probable or causal relationship to the study treatment were recorded. For this study, an AE is an untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.
Blood and lymphatic system disorders Coagulopathy	0.97% 1/103 • Number of events 1 • Adverse events were collected from time product applied to TBS and up to 30 (+14) day follow-up visit. From initiation of final fascial closure to 6-month follow-up visit, SAEs requiring surgical intervention and assessed as having either an unlikely, possible, probable or causal relationship to the study treatment were recorded. For this study, an AE is an untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.
Blood and lymphatic system disorders Iron Deficiency anaemia	0.97% 1/103 • Number of events 1 • Adverse events were collected from time product applied to TBS and up to 30 (+14) day follow-up visit. From initiation of final fascial closure to 6-month follow-up visit, SAEs requiring surgical intervention and assessed as having either an unlikely, possible, probable or causal relationship to the study treatment were recorded. For this study, an AE is an untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.
Blood and lymphatic system disorders Thromobocytosis	0.97% 1/103 • Number of events 1 • Adverse events were collected from time product applied to TBS and up to 30 (+14) day follow-up visit. From initiation of final fascial closure to 6-month follow-up visit, SAEs requiring surgical intervention and assessed as having either an unlikely, possible, probable or causal relationship to the study treatment were recorded. For this study, an AE is an untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.
Cardiac disorders Atrial fibrillation	2.9% 3/103 • Number of events 3 • Adverse events were collected from time product applied to TBS and up to 30 (+14) day follow-up visit. From initiation of final fascial closure to 6-month follow-up visit, SAEs requiring surgical intervention and assessed as having either an unlikely, possible, probable or causal relationship to the study treatment were recorded. For this study, an AE is an untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.
Cardiac disorders Pericardial effusion	0.97% 1/103 • Number of events 1 • Adverse events were collected from time product applied to TBS and up to 30 (+14) day follow-up visit. From initiation of final fascial closure to 6-month follow-up visit, SAEs requiring surgical intervention and assessed as having either an unlikely, possible, probable or causal relationship to the study treatment were recorded. For this study, an AE is an untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.
Cardiac disorders Tachycardia	0.97% 1/103 • Number of events 1 • Adverse events were collected from time product applied to TBS and up to 30 (+14) day follow-up visit. From initiation of final fascial closure to 6-month follow-up visit, SAEs requiring surgical intervention and assessed as having either an unlikely, possible, probable or causal relationship to the study treatment were recorded. For this study, an AE is an untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.
Gastrointestinal disorders Abdominal distension	1.9% 2/103 • Number of events 2 • Adverse events were collected from time product applied to TBS and up to 30 (+14) day follow-up visit. From initiation of final fascial closure to 6-month follow-up visit, SAEs requiring surgical intervention and assessed as having either an unlikely, possible, probable or causal relationship to the study treatment were recorded. For this study, an AE is an untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.
Gastrointestinal disorders Abdominal pain	6.8% 7/103 • Number of events 7 • Adverse events were collected from time product applied to TBS and up to 30 (+14) day follow-up visit. From initiation of final fascial closure to 6-month follow-up visit, SAEs requiring surgical intervention and assessed as having either an unlikely, possible, probable or causal relationship to the study treatment were recorded. For this study, an AE is an untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.
Gastrointestinal disorders Abdominal pain upper	0.97% 1/103 • Number of events 1 • Adverse events were collected from time product applied to TBS and up to 30 (+14) day follow-up visit. From initiation of final fascial closure to 6-month follow-up visit, SAEs requiring surgical intervention and assessed as having either an unlikely, possible, probable or causal relationship to the study treatment were recorded. For this study, an AE is an untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.
Gastrointestinal disorders Constipation	10.7% 11/103 • Number of events 11 • Adverse events were collected from time product applied to TBS and up to 30 (+14) day follow-up visit. From initiation of final fascial closure to 6-month follow-up visit, SAEs requiring surgical intervention and assessed as having either an unlikely, possible, probable or causal relationship to the study treatment were recorded. For this study, an AE is an untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.
Gastrointestinal disorders Diarrhoea	5.8% 6/103 • Number of events 6 • Adverse events were collected from time product applied to TBS and up to 30 (+14) day follow-up visit. From initiation of final fascial closure to 6-month follow-up visit, SAEs requiring surgical intervention and assessed as having either an unlikely, possible, probable or causal relationship to the study treatment were recorded. For this study, an AE is an untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.
Gastrointestinal disorders Flatulence	0.97% 1/103 • Number of events 1 • Adverse events were collected from time product applied to TBS and up to 30 (+14) day follow-up visit. From initiation of final fascial closure to 6-month follow-up visit, SAEs requiring surgical intervention and assessed as having either an unlikely, possible, probable or causal relationship to the study treatment were recorded. For this study, an AE is an untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.97% 1/103 • Number of events 1 • Adverse events were collected from time product applied to TBS and up to 30 (+14) day follow-up visit. From initiation of final fascial closure to 6-month follow-up visit, SAEs requiring surgical intervention and assessed as having either an unlikely, possible, probable or causal relationship to the study treatment were recorded. For this study, an AE is an untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.
Gastrointestinal disorders Ileus	5.8% 6/103 • Number of events 6 • Adverse events were collected from time product applied to TBS and up to 30 (+14) day follow-up visit. From initiation of final fascial closure to 6-month follow-up visit, SAEs requiring surgical intervention and assessed as having either an unlikely, possible, probable or causal relationship to the study treatment were recorded. For this study, an AE is an untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.
Gastrointestinal disorders Impaired gastric emptying	2.9% 3/103 • Number of events 3 • Adverse events were collected from time product applied to TBS and up to 30 (+14) day follow-up visit. From initiation of final fascial closure to 6-month follow-up visit, SAEs requiring surgical intervention and assessed as having either an unlikely, possible, probable or causal relationship to the study treatment were recorded. For this study, an AE is an untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.
Gastrointestinal disorders Intra-abdominal fluid collection	0.97% 1/103 • Number of events 1 • Adverse events were collected from time product applied to TBS and up to 30 (+14) day follow-up visit. From initiation of final fascial closure to 6-month follow-up visit, SAEs requiring surgical intervention and assessed as having either an unlikely, possible, probable or causal relationship to the study treatment were recorded. For this study, an AE is an untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.
Gastrointestinal disorders Intra-abdominal haematoma	0.97% 1/103 • Number of events 1 • Adverse events were collected from time product applied to TBS and up to 30 (+14) day follow-up visit. From initiation of final fascial closure to 6-month follow-up visit, SAEs requiring surgical intervention and assessed as having either an unlikely, possible, probable or causal relationship to the study treatment were recorded. For this study, an AE is an untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.
Gastrointestinal disorders Nausea	21.4% 22/103 • Number of events 23 • Adverse events were collected from time product applied to TBS and up to 30 (+14) day follow-up visit. From initiation of final fascial closure to 6-month follow-up visit, SAEs requiring surgical intervention and assessed as having either an unlikely, possible, probable or causal relationship to the study treatment were recorded. For this study, an AE is an untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.
Gastrointestinal disorders Obstruction gastric	0.97% 1/103 • Number of events 1 • Adverse events were collected from time product applied to TBS and up to 30 (+14) day follow-up visit. From initiation of final fascial closure to 6-month follow-up visit, SAEs requiring surgical intervention and assessed as having either an unlikely, possible, probable or causal relationship to the study treatment were recorded. For this study, an AE is an untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.
Gastrointestinal disorders Steatorrhoea	2.9% 3/103 • Number of events 3 • Adverse events were collected from time product applied to TBS and up to 30 (+14) day follow-up visit. From initiation of final fascial closure to 6-month follow-up visit, SAEs requiring surgical intervention and assessed as having either an unlikely, possible, probable or causal relationship to the study treatment were recorded. For this study, an AE is an untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.
Gastrointestinal disorders Vomiting	10.7% 11/103 • Number of events 12 • Adverse events were collected from time product applied to TBS and up to 30 (+14) day follow-up visit. From initiation of final fascial closure to 6-month follow-up visit, SAEs requiring surgical intervention and assessed as having either an unlikely, possible, probable or causal relationship to the study treatment were recorded. For this study, an AE is an untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.
General disorders Chest pain	0.97% 1/103 • Number of events 1 • Adverse events were collected from time product applied to TBS and up to 30 (+14) day follow-up visit. From initiation of final fascial closure to 6-month follow-up visit, SAEs requiring surgical intervention and assessed as having either an unlikely, possible, probable or causal relationship to the study treatment were recorded. For this study, an AE is an untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.
General disorders Fatigue	0.97% 1/103 • Number of events 1 • Adverse events were collected from time product applied to TBS and up to 30 (+14) day follow-up visit. From initiation of final fascial closure to 6-month follow-up visit, SAEs requiring surgical intervention and assessed as having either an unlikely, possible, probable or causal relationship to the study treatment were recorded. For this study, an AE is an untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.
General disorders Hypothermia	0.97% 1/103 • Number of events 1 • Adverse events were collected from time product applied to TBS and up to 30 (+14) day follow-up visit. From initiation of final fascial closure to 6-month follow-up visit, SAEs requiring surgical intervention and assessed as having either an unlikely, possible, probable or causal relationship to the study treatment were recorded. For this study, an AE is an untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.
General disorders Inflammation	0.97% 1/103 • Number of events 1 • Adverse events were collected from time product applied to TBS and up to 30 (+14) day follow-up visit. From initiation of final fascial closure to 6-month follow-up visit, SAEs requiring surgical intervention and assessed as having either an unlikely, possible, probable or causal relationship to the study treatment were recorded. For this study, an AE is an untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.
General disorders Oedema peripheral	0.97% 1/103 • Number of events 1 • Adverse events were collected from time product applied to TBS and up to 30 (+14) day follow-up visit. From initiation of final fascial closure to 6-month follow-up visit, SAEs requiring surgical intervention and assessed as having either an unlikely, possible, probable or causal relationship to the study treatment were recorded. For this study, an AE is an untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.
General disorders Pyrexia	3.9% 4/103 • Number of events 5 • Adverse events were collected from time product applied to TBS and up to 30 (+14) day follow-up visit. From initiation of final fascial closure to 6-month follow-up visit, SAEs requiring surgical intervention and assessed as having either an unlikely, possible, probable or causal relationship to the study treatment were recorded. For this study, an AE is an untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.
Hepatobiliary disorders Ischaemic hepatitis	0.97% 1/103 • Number of events 1 • Adverse events were collected from time product applied to TBS and up to 30 (+14) day follow-up visit. From initiation of final fascial closure to 6-month follow-up visit, SAEs requiring surgical intervention and assessed as having either an unlikely, possible, probable or causal relationship to the study treatment were recorded. For this study, an AE is an untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.
Infections and infestations Abdominal infection	0.97% 1/103 • Number of events 2 • Adverse events were collected from time product applied to TBS and up to 30 (+14) day follow-up visit. From initiation of final fascial closure to 6-month follow-up visit, SAEs requiring surgical intervention and assessed as having either an unlikely, possible, probable or causal relationship to the study treatment were recorded. For this study, an AE is an untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.
Infections and infestations Bacterial infection	0.97% 1/103 • Number of events 1 • Adverse events were collected from time product applied to TBS and up to 30 (+14) day follow-up visit. From initiation of final fascial closure to 6-month follow-up visit, SAEs requiring surgical intervention and assessed as having either an unlikely, possible, probable or causal relationship to the study treatment were recorded. For this study, an AE is an untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.
Infections and infestations Biliary tract infection bacterial	0.97% 1/103 • Number of events 1 • Adverse events were collected from time product applied to TBS and up to 30 (+14) day follow-up visit. From initiation of final fascial closure to 6-month follow-up visit, SAEs requiring surgical intervention and assessed as having either an unlikely, possible, probable or causal relationship to the study treatment were recorded. For this study, an AE is an untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.
Infections and infestations Cellulitis	0.97% 1/103 • Number of events 1 • Adverse events were collected from time product applied to TBS and up to 30 (+14) day follow-up visit. From initiation of final fascial closure to 6-month follow-up visit, SAEs requiring surgical intervention and assessed as having either an unlikely, possible, probable or causal relationship to the study treatment were recorded. For this study, an AE is an untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.
Infections and infestations Device related infection	0.97% 1/103 • Number of events 1 • Adverse events were collected from time product applied to TBS and up to 30 (+14) day follow-up visit. From initiation of final fascial closure to 6-month follow-up visit, SAEs requiring surgical intervention and assessed as having either an unlikely, possible, probable or causal relationship to the study treatment were recorded. For this study, an AE is an untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.
Infections and infestations Escherichia infection	0.97% 1/103 • Number of events 1 • Adverse events were collected from time product applied to TBS and up to 30 (+14) day follow-up visit. From initiation of final fascial closure to 6-month follow-up visit, SAEs requiring surgical intervention and assessed as having either an unlikely, possible, probable or causal relationship to the study treatment were recorded. For this study, an AE is an untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.
Infections and infestations Eye infection	0.97% 1/103 • Number of events 1 • Adverse events were collected from time product applied to TBS and up to 30 (+14) day follow-up visit. From initiation of final fascial closure to 6-month follow-up visit, SAEs requiring surgical intervention and assessed as having either an unlikely, possible, probable or causal relationship to the study treatment were recorded. For this study, an AE is an untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.
Infections and infestations Febrile infection	0.97% 1/103 • Number of events 1 • Adverse events were collected from time product applied to TBS and up to 30 (+14) day follow-up visit. From initiation of final fascial closure to 6-month follow-up visit, SAEs requiring surgical intervention and assessed as having either an unlikely, possible, probable or causal relationship to the study treatment were recorded. For this study, an AE is an untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.
Infections and infestations Infection	0.97% 1/103 • Number of events 1 • Adverse events were collected from time product applied to TBS and up to 30 (+14) day follow-up visit. From initiation of final fascial closure to 6-month follow-up visit, SAEs requiring surgical intervention and assessed as having either an unlikely, possible, probable or causal relationship to the study treatment were recorded. For this study, an AE is an untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.
Infections and infestations Lower respiratory tract infection	0.97% 1/103 • Number of events 1 • Adverse events were collected from time product applied to TBS and up to 30 (+14) day follow-up visit. From initiation of final fascial closure to 6-month follow-up visit, SAEs requiring surgical intervention and assessed as having either an unlikely, possible, probable or causal relationship to the study treatment were recorded. For this study, an AE is an untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.
Infections and infestations Oral candidiasis	0.97% 1/103 • Number of events 1 • Adverse events were collected from time product applied to TBS and up to 30 (+14) day follow-up visit. From initiation of final fascial closure to 6-month follow-up visit, SAEs requiring surgical intervention and assessed as having either an unlikely, possible, probable or causal relationship to the study treatment were recorded. For this study, an AE is an untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.
Infections and infestations Pneumonia	0.97% 1/103 • Number of events 1 • Adverse events were collected from time product applied to TBS and up to 30 (+14) day follow-up visit. From initiation of final fascial closure to 6-month follow-up visit, SAEs requiring surgical intervention and assessed as having either an unlikely, possible, probable or causal relationship to the study treatment were recorded. For this study, an AE is an untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.
Infections and infestations Postoperative wound infection	0.97% 1/103 • Number of events 1 • Adverse events were collected from time product applied to TBS and up to 30 (+14) day follow-up visit. From initiation of final fascial closure to 6-month follow-up visit, SAEs requiring surgical intervention and assessed as having either an unlikely, possible, probable or causal relationship to the study treatment were recorded. For this study, an AE is an untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.
Infections and infestations Respiratory tract infection	0.97% 1/103 • Number of events 1 • Adverse events were collected from time product applied to TBS and up to 30 (+14) day follow-up visit. From initiation of final fascial closure to 6-month follow-up visit, SAEs requiring surgical intervention and assessed as having either an unlikely, possible, probable or causal relationship to the study treatment were recorded. For this study, an AE is an untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.
Infections and infestations Urinary tract infection	4.9% 5/103 • Number of events 5 • Adverse events were collected from time product applied to TBS and up to 30 (+14) day follow-up visit. From initiation of final fascial closure to 6-month follow-up visit, SAEs requiring surgical intervention and assessed as having either an unlikely, possible, probable or causal relationship to the study treatment were recorded. For this study, an AE is an untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.
Infections and infestations Wound infection	4.9% 5/103 • Number of events 5 • Adverse events were collected from time product applied to TBS and up to 30 (+14) day follow-up visit. From initiation of final fascial closure to 6-month follow-up visit, SAEs requiring surgical intervention and assessed as having either an unlikely, possible, probable or causal relationship to the study treatment were recorded. For this study, an AE is an untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.
Injury, poisoning and procedural complications Anaemia postoperative	1.9% 2/103 • Number of events 2 • Adverse events were collected from time product applied to TBS and up to 30 (+14) day follow-up visit. From initiation of final fascial closure to 6-month follow-up visit, SAEs requiring surgical intervention and assessed as having either an unlikely, possible, probable or causal relationship to the study treatment were recorded. For this study, an AE is an untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.
Injury, poisoning and procedural complications Fall	0.97% 1/103 • Number of events 1 • Adverse events were collected from time product applied to TBS and up to 30 (+14) day follow-up visit. From initiation of final fascial closure to 6-month follow-up visit, SAEs requiring surgical intervention and assessed as having either an unlikely, possible, probable or causal relationship to the study treatment were recorded. For this study, an AE is an untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.
Injury, poisoning and procedural complications Gastroparesis postoperative	0.97% 1/103 • Number of events 1 • Adverse events were collected from time product applied to TBS and up to 30 (+14) day follow-up visit. From initiation of final fascial closure to 6-month follow-up visit, SAEs requiring surgical intervention and assessed as having either an unlikely, possible, probable or causal relationship to the study treatment were recorded. For this study, an AE is an untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.
Injury, poisoning and procedural complications Incision site pain	0.97% 1/103 • Number of events 1 • Adverse events were collected from time product applied to TBS and up to 30 (+14) day follow-up visit. From initiation of final fascial closure to 6-month follow-up visit, SAEs requiring surgical intervention and assessed as having either an unlikely, possible, probable or causal relationship to the study treatment were recorded. For this study, an AE is an untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.
Injury, poisoning and procedural complications Procedural pain	8.7% 9/103 • Number of events 9 • Adverse events were collected from time product applied to TBS and up to 30 (+14) day follow-up visit. From initiation of final fascial closure to 6-month follow-up visit, SAEs requiring surgical intervention and assessed as having either an unlikely, possible, probable or causal relationship to the study treatment were recorded. For this study, an AE is an untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.
Injury, poisoning and procedural complications Wound dehiscence	2.9% 3/103 • Number of events 3 • Adverse events were collected from time product applied to TBS and up to 30 (+14) day follow-up visit. From initiation of final fascial closure to 6-month follow-up visit, SAEs requiring surgical intervention and assessed as having either an unlikely, possible, probable or causal relationship to the study treatment were recorded. For this study, an AE is an untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.
Injury, poisoning and procedural complications Wound secretion	0.97% 1/103 • Number of events 1 • Adverse events were collected from time product applied to TBS and up to 30 (+14) day follow-up visit. From initiation of final fascial closure to 6-month follow-up visit, SAEs requiring surgical intervention and assessed as having either an unlikely, possible, probable or causal relationship to the study treatment were recorded. For this study, an AE is an untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.
Investigations Bile culture positive	0.97% 1/103 • Number of events 1 • Adverse events were collected from time product applied to TBS and up to 30 (+14) day follow-up visit. From initiation of final fascial closure to 6-month follow-up visit, SAEs requiring surgical intervention and assessed as having either an unlikely, possible, probable or causal relationship to the study treatment were recorded. For this study, an AE is an untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.
Investigations Blood lactic acid increased	1.9% 2/103 • Number of events 2 • Adverse events were collected from time product applied to TBS and up to 30 (+14) day follow-up visit. From initiation of final fascial closure to 6-month follow-up visit, SAEs requiring surgical intervention and assessed as having either an unlikely, possible, probable or causal relationship to the study treatment were recorded. For this study, an AE is an untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.
Investigations Blood magnesium decreased	0.97% 1/103 • Number of events 1 • Adverse events were collected from time product applied to TBS and up to 30 (+14) day follow-up visit. From initiation of final fascial closure to 6-month follow-up visit, SAEs requiring surgical intervention and assessed as having either an unlikely, possible, probable or causal relationship to the study treatment were recorded. For this study, an AE is an untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.
Investigations Blood potassium decreased	1.9% 2/103 • Number of events 2 • Adverse events were collected from time product applied to TBS and up to 30 (+14) day follow-up visit. From initiation of final fascial closure to 6-month follow-up visit, SAEs requiring surgical intervention and assessed as having either an unlikely, possible, probable or causal relationship to the study treatment were recorded. For this study, an AE is an untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.
Investigations Body temperature increased	0.97% 1/103 • Number of events 1 • Adverse events were collected from time product applied to TBS and up to 30 (+14) day follow-up visit. From initiation of final fascial closure to 6-month follow-up visit, SAEs requiring surgical intervention and assessed as having either an unlikely, possible, probable or causal relationship to the study treatment were recorded. For this study, an AE is an untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.
Investigations Haematocrit decreased	0.97% 1/103 • Number of events 1 • Adverse events were collected from time product applied to TBS and up to 30 (+14) day follow-up visit. From initiation of final fascial closure to 6-month follow-up visit, SAEs requiring surgical intervention and assessed as having either an unlikely, possible, probable or causal relationship to the study treatment were recorded. For this study, an AE is an untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.
Investigations Haemoglobin decreased	0.97% 1/103 • Number of events 1 • Adverse events were collected from time product applied to TBS and up to 30 (+14) day follow-up visit. From initiation of final fascial closure to 6-month follow-up visit, SAEs requiring surgical intervention and assessed as having either an unlikely, possible, probable or causal relationship to the study treatment were recorded. For this study, an AE is an untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.
Investigations Liver function test abnormal	0.97% 1/103 • Number of events 1 • Adverse events were collected from time product applied to TBS and up to 30 (+14) day follow-up visit. From initiation of final fascial closure to 6-month follow-up visit, SAEs requiring surgical intervention and assessed as having either an unlikely, possible, probable or causal relationship to the study treatment were recorded. For this study, an AE is an untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.
Investigations Oxygen saturation decreased	0.97% 1/103 • Number of events 1 • Adverse events were collected from time product applied to TBS and up to 30 (+14) day follow-up visit. From initiation of final fascial closure to 6-month follow-up visit, SAEs requiring surgical intervention and assessed as having either an unlikely, possible, probable or causal relationship to the study treatment were recorded. For this study, an AE is an untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.
Investigations Prothrombin time prolonged	0.97% 1/103 • Number of events 1 • Adverse events were collected from time product applied to TBS and up to 30 (+14) day follow-up visit. From initiation of final fascial closure to 6-month follow-up visit, SAEs requiring surgical intervention and assessed as having either an unlikely, possible, probable or causal relationship to the study treatment were recorded. For this study, an AE is an untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.
Investigations Red blood cell count decreased	0.97% 1/103 • Number of events 1 • Adverse events were collected from time product applied to TBS and up to 30 (+14) day follow-up visit. From initiation of final fascial closure to 6-month follow-up visit, SAEs requiring surgical intervention and assessed as having either an unlikely, possible, probable or causal relationship to the study treatment were recorded. For this study, an AE is an untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.
Investigations Urine output decreased	2.9% 3/103 • Number of events 3 • Adverse events were collected from time product applied to TBS and up to 30 (+14) day follow-up visit. From initiation of final fascial closure to 6-month follow-up visit, SAEs requiring surgical intervention and assessed as having either an unlikely, possible, probable or causal relationship to the study treatment were recorded. For this study, an AE is an untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.
Investigations Weight decreased	0.97% 1/103 • Number of events 1 • Adverse events were collected from time product applied to TBS and up to 30 (+14) day follow-up visit. From initiation of final fascial closure to 6-month follow-up visit, SAEs requiring surgical intervention and assessed as having either an unlikely, possible, probable or causal relationship to the study treatment were recorded. For this study, an AE is an untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.
Metabolism and nutrition disorders Decreased appetite	0.97% 1/103 • Number of events 1 • Adverse events were collected from time product applied to TBS and up to 30 (+14) day follow-up visit. From initiation of final fascial closure to 6-month follow-up visit, SAEs requiring surgical intervention and assessed as having either an unlikely, possible, probable or causal relationship to the study treatment were recorded. For this study, an AE is an untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.
Metabolism and nutrition disorders Electrolyte imbalance	1.9% 2/103 • Number of events 2 • Adverse events were collected from time product applied to TBS and up to 30 (+14) day follow-up visit. From initiation of final fascial closure to 6-month follow-up visit, SAEs requiring surgical intervention and assessed as having either an unlikely, possible, probable or causal relationship to the study treatment were recorded. For this study, an AE is an untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.
Metabolism and nutrition disorders Hyperglycaemia	1.9% 2/103 • Number of events 2 • Adverse events were collected from time product applied to TBS and up to 30 (+14) day follow-up visit. From initiation of final fascial closure to 6-month follow-up visit, SAEs requiring surgical intervention and assessed as having either an unlikely, possible, probable or causal relationship to the study treatment were recorded. For this study, an AE is an untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.
Metabolism and nutrition disorders Hyperkalaemia	0.97% 1/103 • Number of events 1 • Adverse events were collected from time product applied to TBS and up to 30 (+14) day follow-up visit. From initiation of final fascial closure to 6-month follow-up visit, SAEs requiring surgical intervention and assessed as having either an unlikely, possible, probable or causal relationship to the study treatment were recorded. For this study, an AE is an untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.
Metabolism and nutrition disorders Hypocalcaemia	0.97% 1/103 • Number of events 1 • Adverse events were collected from time product applied to TBS and up to 30 (+14) day follow-up visit. From initiation of final fascial closure to 6-month follow-up visit, SAEs requiring surgical intervention and assessed as having either an unlikely, possible, probable or causal relationship to the study treatment were recorded. For this study, an AE is an untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.
Metabolism and nutrition disorders Hyponatraemia	0.97% 1/103 • Number of events 1 • Adverse events were collected from time product applied to TBS and up to 30 (+14) day follow-up visit. From initiation of final fascial closure to 6-month follow-up visit, SAEs requiring surgical intervention and assessed as having either an unlikely, possible, probable or causal relationship to the study treatment were recorded. For this study, an AE is an untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.
Metabolism and nutrition disorders Hypophosphataemia	0.97% 1/103 • Number of events 1 • Adverse events were collected from time product applied to TBS and up to 30 (+14) day follow-up visit. From initiation of final fascial closure to 6-month follow-up visit, SAEs requiring surgical intervention and assessed as having either an unlikely, possible, probable or causal relationship to the study treatment were recorded. For this study, an AE is an untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.
Metabolism and nutrition disorders Hypovolaemia	1.9% 2/103 • Number of events 2 • Adverse events were collected from time product applied to TBS and up to 30 (+14) day follow-up visit. From initiation of final fascial closure to 6-month follow-up visit, SAEs requiring surgical intervention and assessed as having either an unlikely, possible, probable or causal relationship to the study treatment were recorded. For this study, an AE is an untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.
Metabolism and nutrition disorders Metabolic acidosis	1.9% 2/103 • Number of events 2 • Adverse events were collected from time product applied to TBS and up to 30 (+14) day follow-up visit. From initiation of final fascial closure to 6-month follow-up visit, SAEs requiring surgical intervention and assessed as having either an unlikely, possible, probable or causal relationship to the study treatment were recorded. For this study, an AE is an untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.
Musculoskeletal and connective tissue disorders Back pain	0.97% 1/103 • Number of events 1 • Adverse events were collected from time product applied to TBS and up to 30 (+14) day follow-up visit. From initiation of final fascial closure to 6-month follow-up visit, SAEs requiring surgical intervention and assessed as having either an unlikely, possible, probable or causal relationship to the study treatment were recorded. For this study, an AE is an untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.
Nervous system disorders Dizziness	0.97% 1/103 • Number of events 1 • Adverse events were collected from time product applied to TBS and up to 30 (+14) day follow-up visit. From initiation of final fascial closure to 6-month follow-up visit, SAEs requiring surgical intervention and assessed as having either an unlikely, possible, probable or causal relationship to the study treatment were recorded. For this study, an AE is an untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.
Nervous system disorders Headache	2.9% 3/103 • Number of events 3 • Adverse events were collected from time product applied to TBS and up to 30 (+14) day follow-up visit. From initiation of final fascial closure to 6-month follow-up visit, SAEs requiring surgical intervention and assessed as having either an unlikely, possible, probable or causal relationship to the study treatment were recorded. For this study, an AE is an untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.
Nervous system disorders Hypoaesthesia	1.9% 2/103 • Number of events 2 • Adverse events were collected from time product applied to TBS and up to 30 (+14) day follow-up visit. From initiation of final fascial closure to 6-month follow-up visit, SAEs requiring surgical intervention and assessed as having either an unlikely, possible, probable or causal relationship to the study treatment were recorded. For this study, an AE is an untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.
Nervous system disorders Presyncope	1.9% 2/103 • Number of events 2 • Adverse events were collected from time product applied to TBS and up to 30 (+14) day follow-up visit. From initiation of final fascial closure to 6-month follow-up visit, SAEs requiring surgical intervention and assessed as having either an unlikely, possible, probable or causal relationship to the study treatment were recorded. For this study, an AE is an untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.
Psychiatric disorders Anorexia nervosa	0.97% 1/103 • Number of events 1 • Adverse events were collected from time product applied to TBS and up to 30 (+14) day follow-up visit. From initiation of final fascial closure to 6-month follow-up visit, SAEs requiring surgical intervention and assessed as having either an unlikely, possible, probable or causal relationship to the study treatment were recorded. For this study, an AE is an untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.
Psychiatric disorders Anxiety	1.9% 2/103 • Number of events 2 • Adverse events were collected from time product applied to TBS and up to 30 (+14) day follow-up visit. From initiation of final fascial closure to 6-month follow-up visit, SAEs requiring surgical intervention and assessed as having either an unlikely, possible, probable or causal relationship to the study treatment were recorded. For this study, an AE is an untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.
Psychiatric disorders Delirium	0.97% 1/103 • Number of events 1 • Adverse events were collected from time product applied to TBS and up to 30 (+14) day follow-up visit. From initiation of final fascial closure to 6-month follow-up visit, SAEs requiring surgical intervention and assessed as having either an unlikely, possible, probable or causal relationship to the study treatment were recorded. For this study, an AE is an untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.
Psychiatric disorders Hallucination	0.97% 1/103 • Number of events 1 • Adverse events were collected from time product applied to TBS and up to 30 (+14) day follow-up visit. From initiation of final fascial closure to 6-month follow-up visit, SAEs requiring surgical intervention and assessed as having either an unlikely, possible, probable or causal relationship to the study treatment were recorded. For this study, an AE is an untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.
Renal and urinary disorders Acute kidney injury	0.97% 1/103 • Number of events 1 • Adverse events were collected from time product applied to TBS and up to 30 (+14) day follow-up visit. From initiation of final fascial closure to 6-month follow-up visit, SAEs requiring surgical intervention and assessed as having either an unlikely, possible, probable or causal relationship to the study treatment were recorded. For this study, an AE is an untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.
Renal and urinary disorders Oliguria	0.97% 1/103 • Number of events 1 • Adverse events were collected from time product applied to TBS and up to 30 (+14) day follow-up visit. From initiation of final fascial closure to 6-month follow-up visit, SAEs requiring surgical intervention and assessed as having either an unlikely, possible, probable or causal relationship to the study treatment were recorded. For this study, an AE is an untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.
Renal and urinary disorders Renal impairment	0.97% 1/103 • Number of events 1 • Adverse events were collected from time product applied to TBS and up to 30 (+14) day follow-up visit. From initiation of final fascial closure to 6-month follow-up visit, SAEs requiring surgical intervention and assessed as having either an unlikely, possible, probable or causal relationship to the study treatment were recorded. For this study, an AE is an untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.
Renal and urinary disorders Urinary retention	0.97% 1/103 • Number of events 1 • Adverse events were collected from time product applied to TBS and up to 30 (+14) day follow-up visit. From initiation of final fascial closure to 6-month follow-up visit, SAEs requiring surgical intervention and assessed as having either an unlikely, possible, probable or causal relationship to the study treatment were recorded. For this study, an AE is an untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.
Reproductive system and breast disorders Testicular pain	0.97% 1/103 • Number of events 1 • Adverse events were collected from time product applied to TBS and up to 30 (+14) day follow-up visit. From initiation of final fascial closure to 6-month follow-up visit, SAEs requiring surgical intervention and assessed as having either an unlikely, possible, probable or causal relationship to the study treatment were recorded. For this study, an AE is an untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.
Reproductive system and breast disorders Vaginal haemorrhage	1.9% 2/103 • Number of events 2 • Adverse events were collected from time product applied to TBS and up to 30 (+14) day follow-up visit. From initiation of final fascial closure to 6-month follow-up visit, SAEs requiring surgical intervention and assessed as having either an unlikely, possible, probable or causal relationship to the study treatment were recorded. For this study, an AE is an untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.
Respiratory, thoracic and mediastinal disorders Atelectasis	0.97% 1/103 • Number of events 1 • Adverse events were collected from time product applied to TBS and up to 30 (+14) day follow-up visit. From initiation of final fascial closure to 6-month follow-up visit, SAEs requiring surgical intervention and assessed as having either an unlikely, possible, probable or causal relationship to the study treatment were recorded. For this study, an AE is an untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.97% 1/103 • Number of events 1 • Adverse events were collected from time product applied to TBS and up to 30 (+14) day follow-up visit. From initiation of final fascial closure to 6-month follow-up visit, SAEs requiring surgical intervention and assessed as having either an unlikely, possible, probable or causal relationship to the study treatment were recorded. For this study, an AE is an untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.
Respiratory, thoracic and mediastinal disorders Lung consolidation	0.97% 1/103 • Number of events 1 • Adverse events were collected from time product applied to TBS and up to 30 (+14) day follow-up visit. From initiation of final fascial closure to 6-month follow-up visit, SAEs requiring surgical intervention and assessed as having either an unlikely, possible, probable or causal relationship to the study treatment were recorded. For this study, an AE is an untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.97% 1/103 • Number of events 1 • Adverse events were collected from time product applied to TBS and up to 30 (+14) day follow-up visit. From initiation of final fascial closure to 6-month follow-up visit, SAEs requiring surgical intervention and assessed as having either an unlikely, possible, probable or causal relationship to the study treatment were recorded. For this study, an AE is an untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.
Respiratory, thoracic and mediastinal disorders Pleural effusion	3.9% 4/103 • Number of events 4 • Adverse events were collected from time product applied to TBS and up to 30 (+14) day follow-up visit. From initiation of final fascial closure to 6-month follow-up visit, SAEs requiring surgical intervention and assessed as having either an unlikely, possible, probable or causal relationship to the study treatment were recorded. For this study, an AE is an untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	0.97% 1/103 • Number of events 1 • Adverse events were collected from time product applied to TBS and up to 30 (+14) day follow-up visit. From initiation of final fascial closure to 6-month follow-up visit, SAEs requiring surgical intervention and assessed as having either an unlikely, possible, probable or causal relationship to the study treatment were recorded. For this study, an AE is an untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.97% 1/103 • Number of events 1 • Adverse events were collected from time product applied to TBS and up to 30 (+14) day follow-up visit. From initiation of final fascial closure to 6-month follow-up visit, SAEs requiring surgical intervention and assessed as having either an unlikely, possible, probable or causal relationship to the study treatment were recorded. For this study, an AE is an untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.
Respiratory, thoracic and mediastinal disorders Wheezing	0.97% 1/103 • Number of events 1 • Adverse events were collected from time product applied to TBS and up to 30 (+14) day follow-up visit. From initiation of final fascial closure to 6-month follow-up visit, SAEs requiring surgical intervention and assessed as having either an unlikely, possible, probable or causal relationship to the study treatment were recorded. For this study, an AE is an untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.
Skin and subcutaneous tissue disorders Pityriasis rubra pilaris	0.97% 1/103 • Number of events 1 • Adverse events were collected from time product applied to TBS and up to 30 (+14) day follow-up visit. From initiation of final fascial closure to 6-month follow-up visit, SAEs requiring surgical intervention and assessed as having either an unlikely, possible, probable or causal relationship to the study treatment were recorded. For this study, an AE is an untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.
Skin and subcutaneous tissue disorders Pruritus	3.9% 4/103 • Number of events 4 • Adverse events were collected from time product applied to TBS and up to 30 (+14) day follow-up visit. From initiation of final fascial closure to 6-month follow-up visit, SAEs requiring surgical intervention and assessed as having either an unlikely, possible, probable or causal relationship to the study treatment were recorded. For this study, an AE is an untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.
Skin and subcutaneous tissue disorders Rash pruritic	0.97% 1/103 • Number of events 1 • Adverse events were collected from time product applied to TBS and up to 30 (+14) day follow-up visit. From initiation of final fascial closure to 6-month follow-up visit, SAEs requiring surgical intervention and assessed as having either an unlikely, possible, probable or causal relationship to the study treatment were recorded. For this study, an AE is an untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.
Vascular disorders Hypertension	4.9% 5/103 • Number of events 5 • Adverse events were collected from time product applied to TBS and up to 30 (+14) day follow-up visit. From initiation of final fascial closure to 6-month follow-up visit, SAEs requiring surgical intervention and assessed as having either an unlikely, possible, probable or causal relationship to the study treatment were recorded. For this study, an AE is an untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.
Vascular disorders Hypotension	6.8% 7/103 • Number of events 7 • Adverse events were collected from time product applied to TBS and up to 30 (+14) day follow-up visit. From initiation of final fascial closure to 6-month follow-up visit, SAEs requiring surgical intervention and assessed as having either an unlikely, possible, probable or causal relationship to the study treatment were recorded. For this study, an AE is an untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.
Vascular disorders Thrombophlebitis superficial	0.97% 1/103 • Number of events 1 • Adverse events were collected from time product applied to TBS and up to 30 (+14) day follow-up visit. From initiation of final fascial closure to 6-month follow-up visit, SAEs requiring surgical intervention and assessed as having either an unlikely, possible, probable or causal relationship to the study treatment were recorded. For this study, an AE is an untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.

Additional Information

Patricia Schleckser

ETHICON, Inc

Phone: 01 908 218 2244

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Publication based on results shall not be made before the first multi-centre publication. Trust and/or Investigator may prepare data derived from the Clinical Investigation for publication. Sponsor to be given at least 60 days for review. During review period, Sponsor is entitled to request publication be delayed for up to 6 months from date of first submission to Sponsor to enable Sponsor to take steps to protect its proprietary information and/or Intellectual Property Rights and Know How.
Publication restrictions are in place

Restriction type: OTHER