Trial Outcomes & Findings for A Prospective Trial of a Bio-absorbable Mesh in Challenging Laparoscopic Ventral or Incisional Hernia Repair (NCT NCT02712398)

Last Updated: 2021-01-08

Results Overview

Proportion of subjects with Surgical Site Occurrences(SSO), which are defined as hematoma, seroma, surgical site infection, wound dehiscence, skin necrosis and fistula requiring intervention. Occurrences at the surgical site will be assessed by physical examination at each study visit through 45 days.

Recruitment status

COMPLETED

Study phase

Target enrollment

120 participants

Primary outcome timeframe

45 Days

Results posted on

2021-01-08

Participant Flow

Participant milestones

Participant milestones
Measure	Phasix™ ST Subjects treated with Phasix™ ST mesh Phasix™ ST: Phasix™ ST is a fully resorbable mesh with a hydrogel coating that is also resorbable.
Overall Study STARTED	120
Overall Study COMPLETED	83
Overall Study NOT COMPLETED	37

Reasons for withdrawal

Reasons for withdrawal
Measure	Phasix™ ST Subjects treated with Phasix™ ST mesh Phasix™ ST: Phasix™ ST is a fully resorbable mesh with a hydrogel coating that is also resorbable.
Overall Study Withdrawal by Subject	6
Overall Study Lost to Follow-up	6
Overall Study Sponsor Decision	1
Overall Study Physician Decision	1
Overall Study Death	2
Overall Study Re-operation	21

Baseline Characteristics

A Prospective Trial of a Bio-absorbable Mesh in Challenging Laparoscopic Ventral or Incisional Hernia Repair

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Phasix™ ST n=120 Participants Subjects treated with Phasix™ ST mesh Phasix™ ST: Phasix™ ST is a fully resorbable mesh with a hydrogel coating that is also resorbable.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	84 Participants n=5 Participants
Age, Categorical >=65 years	36 Participants n=5 Participants
Age, Continuous	55.0 Years STANDARD_DEVIATION 14.93 • n=5 Participants
Sex: Female, Male Female	57 Participants n=5 Participants
Sex: Female, Male Male	63 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	119 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	7 Participants n=5 Participants
Race (NIH/OMB) White	110 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Region of Enrollment United States	120 participants n=5 Participants
BMI	33.2 kg/m^2 STANDARD_DEVIATION 4.48 • n=5 Participants

PRIMARY outcome

Timeframe: 45 Days

Outcome measures

Outcome measures
Measure	Phasix™ ST n=120 Participants Subjects treated with Phasix™ ST mesh Phasix™ ST: Phasix™ ST is a fully resorbable mesh with a hydrogel coating that is also resorbable.
Surgical Site Occurrence Rate	1 subjects

SECONDARY outcome

Timeframe: 3 months

Number of subjects with Surgical Site Occurrences, which are defined as hematoma, seroma, surgical site infection, wound dehiscence, skin necrosis and fistula requiring intervention. Occurrences at the surgical site will be assessed by physical examination at each study visit through 3 months.

Outcome measures

Outcome measures
Measure	Phasix™ ST n=120 Participants Subjects treated with Phasix™ ST mesh Phasix™ ST: Phasix™ ST is a fully resorbable mesh with a hydrogel coating that is also resorbable.
Surgical Site Occurrence Rate	0 subjects

SECONDARY outcome

Timeframe: 24 Months

Proportion of subjects with hernia recurrence. Hernia recurrence rates will be assessed by physical examination (or if standard of care via CT/MRI or ultrasonography) at each study visit through 24 months. A recurrent hernia will be defined as any hernia identified or confirmed by the investigator, during any study follow-up visit, in approximately the same position as the hernia repaired in the study procedure.

Outcome measures

Outcome measures
Measure	Phasix™ ST n=120 Participants Subjects treated with Phasix™ ST mesh Phasix™ ST: Phasix™ ST is a fully resorbable mesh with a hydrogel coating that is also resorbable.
Hernia Recurrence Rate	38 Participants

SECONDARY outcome

Timeframe: 24 Months

Mean change in self-reported pain measured on a Visual Analog Scale between Baseline and 24-month through follow up. Scores are measured on a 10.0 cm line, scores range from 0 to 10, higher values correspond with higher pain perception. The outcome measure is presented as the absolute difference between the pain perception at Baseline and the pain perception at 24-month follow up.

Outcome measures

Outcome measures
Measure	Phasix™ ST n=120 Participants Subjects treated with Phasix™ ST mesh Phasix™ ST: Phasix™ ST is a fully resorbable mesh with a hydrogel coating that is also resorbable.
Pain Visual Analog Scale	0.94 centimeters Standard Deviation 1.63

SECONDARY outcome

Timeframe: 24 Months

Proportion of subjects with Investigator-determined device-related adverse events

Outcome measures

Outcome measures
Measure	Phasix™ ST n=120 Participants Subjects treated with Phasix™ ST mesh Phasix™ ST: Phasix™ ST is a fully resorbable mesh with a hydrogel coating that is also resorbable.
Device-related Adverse Event Incidence	49 subjects

SECONDARY outcome

Timeframe: 24 Months

Rate of reoperation due to the index hernia repair

Outcome measures

Outcome measures
Measure	Phasix™ ST n=120 Participants Subjects treated with Phasix™ ST mesh Phasix™ ST: Phasix™ ST is a fully resorbable mesh with a hydrogel coating that is also resorbable.
Rate of Reoperation Due to Index Hernia Repair	22 Participants

SECONDARY outcome

Timeframe: 24 Months

Each scale score (sensation of mesh, pain or movement limitations) ranges from 0-5 and is the average across the domains. The Total CCS Score ranges from 0-5 and is the average of the 3 scale scores. Low scores represent fewer symptoms or difficulties. Absolute values of the Total CCS Score at Baseline, 1-Month follow-up, at 3-Month follow-up, at 6-Month follow-up, at 12-Month follow-up, at 18-Month follow-up, and at 24-Month follow up are reported. The absolute value at Baseline, or a change in self-reported quality of life measured by Carolinas Comfort Scale® cannot be reported, as subjects had incorrectly answered the questions on Sensation of Mesh at Baseline where no Phasix Mesh was yet implanted, thereby creating a bias in the results.

Outcome measures

Outcome measures
Measure	Phasix™ ST n=120 Participants Subjects treated with Phasix™ ST mesh Phasix™ ST: Phasix™ ST is a fully resorbable mesh with a hydrogel coating that is also resorbable.
Change in Carolinas Comfort Scale Total CCS Score - Baseline	1.15 units on a scale Standard Deviation 1.059
Change in Carolinas Comfort Scale Total CCS Score - 12 Month	0.13 units on a scale Standard Deviation 0.353
Change in Carolinas Comfort Scale Total CCS Score - 18 Month	0.17 units on a scale Standard Deviation 0.377
Change in Carolinas Comfort Scale Total CCS Score - 24 Month	0.17 units on a scale Standard Deviation 0.425
Change in Carolinas Comfort Scale Total CCS Score - 1 Month	0.85 units on a scale Standard Deviation 0.938
Change in Carolinas Comfort Scale Total CCS Score - 3 Month	0.34 units on a scale Standard Deviation 0.601
Change in Carolinas Comfort Scale Total CCS Score - 6 Month	0.22 units on a scale Standard Deviation 0.523

SECONDARY outcome

Timeframe: 24 Months

The Short Form (SF)-12 version 2 (v2) is a multi-purpose, twelve item health survey that measures seven domains of health: general health, physical functioning, role limitations due to physical health (role-physical), role limitations due to emotional problems (role-emotional), bodily pain, vitality and mental health and social functioning. The SF-12v2 yields scale scores for each of these seven health domains, and two summary measures of physical and mental health: the physical component summary (PCS) and mental component summary (MCS). The scores range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health. Absolute values of the PCS and MCS scores at Baseline, 1-Month follow-up, at 3-Month follow-up, at 6-Month follow-up, at 12-Month follow-up, at 18-Month follow-up, and at 24-Month follow up are reported.

Outcome measures

Outcome measures
Measure	Phasix™ ST n=120 Participants Subjects treated with Phasix™ ST mesh Phasix™ ST: Phasix™ ST is a fully resorbable mesh with a hydrogel coating that is also resorbable.
Change in SF(Short-form)-12 PCS - 3 Month	48.83 score on a scale Standard Deviation 8.026
Change in SF(Short-form)-12 PCS - 6 Month	49.99 score on a scale Standard Deviation 8.277
Change in SF(Short-form)-12 PCS - 18 Month	50.48 score on a scale Standard Deviation 8.794
Change in SF(Short-form)-12 PCS - 24 Month	48.02 score on a scale Standard Deviation 9.739
Change in SF(Short-form)-12 MCS - Baseline	53.47 score on a scale Standard Deviation 9.493
Change in SF(Short-form)-12 MCS - 12 Month	50.10 score on a scale Standard Deviation 8.248
Change in SF(Short-form)-12 MCS - 18 Month	50.48 score on a scale Standard Deviation 8.794
Change in SF(Short-form)-12 MCS - 24 Month	48.02 score on a scale Standard Deviation 9.739
Change in SF(Short-form)-12 PCS - Baseline	44.38 score on a scale Standard Deviation 9.635
Change in SF(Short-form)-12 PCS - 1 Month	40.35 score on a scale Standard Deviation 9.349
Change in SF(Short-form)-12 PCS - 12 Month	50.10 score on a scale Standard Deviation 8.248
Change in SF(Short-form)-12 MCS - 1 Month	40.35 score on a scale Standard Deviation 9.349
Change in SF(Short-form)-12 MCS - 3 Month	48.83 score on a scale Standard Deviation 8.026
Change in SF(Short-form)-12 MCS - 6 Month	49.99 score on a scale Standard Deviation 8.277

SECONDARY outcome

Timeframe: During Procedure, up to 243 minutes

Surgical procedure time as measured from incision to closure (skin to skin)

Outcome measures

Outcome measures
Measure	Phasix™ ST n=120 Participants Subjects treated with Phasix™ ST mesh Phasix™ ST: Phasix™ ST is a fully resorbable mesh with a hydrogel coating that is also resorbable.
Surgical Procedure Time as Measured From Incision to Closure	85.9 Minutes Standard Deviation 43.03

SECONDARY outcome

Timeframe: 1 month

Number of days admitted to the hospital for index surgery

Outcome measures

Outcome measures
Measure	Phasix™ ST n=120 Participants Subjects treated with Phasix™ ST mesh Phasix™ ST: Phasix™ ST is a fully resorbable mesh with a hydrogel coating that is also resorbable.
Length of Hospital Stay	1.0 days Standard Deviation 1.35

Adverse Events

Phasix™ ST

Serious events: 44 serious events

Other events: 64 other events

Deaths: 2 deaths

Serious adverse events

Serious adverse events
Measure	Phasix™ ST n=120 participants at risk Subjects treated with Phasix™ ST mesh Phasix™ ST: Phasix™ ST is a fully resorbable mesh with a hydrogel coating that is also resorbable.
Cardiac disorders Atrioventricular block complete	0.83% 1/120 • Number of events 1 • 24 Months In this study, an Adverse Event (AE) is defined as any undesirable clinical event occurring in the abdominal space including the lower abdominal, inguinal and pubic regions (including the skin), as well as any other undesirable clinical events judged to be related to the study device or surgical procedure regardless of anatomical region. The definition of Serious AE does not deviate. Monitors have actively reviewed the subjects' medical records for Adverse Events during monitor visits.
Cardiac disorders Bradycardia	0.83% 1/120 • Number of events 1 • 24 Months In this study, an Adverse Event (AE) is defined as any undesirable clinical event occurring in the abdominal space including the lower abdominal, inguinal and pubic regions (including the skin), as well as any other undesirable clinical events judged to be related to the study device or surgical procedure regardless of anatomical region. The definition of Serious AE does not deviate. Monitors have actively reviewed the subjects' medical records for Adverse Events during monitor visits.
Cardiac disorders Cardio-respiratory arrest	0.83% 1/120 • Number of events 1 • 24 Months In this study, an Adverse Event (AE) is defined as any undesirable clinical event occurring in the abdominal space including the lower abdominal, inguinal and pubic regions (including the skin), as well as any other undesirable clinical events judged to be related to the study device or surgical procedure regardless of anatomical region. The definition of Serious AE does not deviate. Monitors have actively reviewed the subjects' medical records for Adverse Events during monitor visits.
Congenital, familial and genetic disorders Pseudocholinesterase deficiency	0.83% 1/120 • Number of events 1 • 24 Months In this study, an Adverse Event (AE) is defined as any undesirable clinical event occurring in the abdominal space including the lower abdominal, inguinal and pubic regions (including the skin), as well as any other undesirable clinical events judged to be related to the study device or surgical procedure regardless of anatomical region. The definition of Serious AE does not deviate. Monitors have actively reviewed the subjects' medical records for Adverse Events during monitor visits.
Gastrointestinal disorders Abdominal adhesions	0.83% 1/120 • Number of events 1 • 24 Months In this study, an Adverse Event (AE) is defined as any undesirable clinical event occurring in the abdominal space including the lower abdominal, inguinal and pubic regions (including the skin), as well as any other undesirable clinical events judged to be related to the study device or surgical procedure regardless of anatomical region. The definition of Serious AE does not deviate. Monitors have actively reviewed the subjects' medical records for Adverse Events during monitor visits.
Gastrointestinal disorders Crohn's disease	0.83% 1/120 • Number of events 1 • 24 Months In this study, an Adverse Event (AE) is defined as any undesirable clinical event occurring in the abdominal space including the lower abdominal, inguinal and pubic regions (including the skin), as well as any other undesirable clinical events judged to be related to the study device or surgical procedure regardless of anatomical region. The definition of Serious AE does not deviate. Monitors have actively reviewed the subjects' medical records for Adverse Events during monitor visits.
Gastrointestinal disorders Cyclic vomiting syndrome	0.83% 1/120 • Number of events 1 • 24 Months In this study, an Adverse Event (AE) is defined as any undesirable clinical event occurring in the abdominal space including the lower abdominal, inguinal and pubic regions (including the skin), as well as any other undesirable clinical events judged to be related to the study device or surgical procedure regardless of anatomical region. The definition of Serious AE does not deviate. Monitors have actively reviewed the subjects' medical records for Adverse Events during monitor visits.
Gastrointestinal disorders Dyspepsia	0.83% 1/120 • Number of events 1 • 24 Months In this study, an Adverse Event (AE) is defined as any undesirable clinical event occurring in the abdominal space including the lower abdominal, inguinal and pubic regions (including the skin), as well as any other undesirable clinical events judged to be related to the study device or surgical procedure regardless of anatomical region. The definition of Serious AE does not deviate. Monitors have actively reviewed the subjects' medical records for Adverse Events during monitor visits.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.83% 1/120 • Number of events 1 • 24 Months In this study, an Adverse Event (AE) is defined as any undesirable clinical event occurring in the abdominal space including the lower abdominal, inguinal and pubic regions (including the skin), as well as any other undesirable clinical events judged to be related to the study device or surgical procedure regardless of anatomical region. The definition of Serious AE does not deviate. Monitors have actively reviewed the subjects' medical records for Adverse Events during monitor visits.
Gastrointestinal disorders Hiatus hernia	0.83% 1/120 • Number of events 1 • 24 Months In this study, an Adverse Event (AE) is defined as any undesirable clinical event occurring in the abdominal space including the lower abdominal, inguinal and pubic regions (including the skin), as well as any other undesirable clinical events judged to be related to the study device or surgical procedure regardless of anatomical region. The definition of Serious AE does not deviate. Monitors have actively reviewed the subjects' medical records for Adverse Events during monitor visits.
Gastrointestinal disorders Small intestinal obstruction	1.7% 2/120 • Number of events 2 • 24 Months In this study, an Adverse Event (AE) is defined as any undesirable clinical event occurring in the abdominal space including the lower abdominal, inguinal and pubic regions (including the skin), as well as any other undesirable clinical events judged to be related to the study device or surgical procedure regardless of anatomical region. The definition of Serious AE does not deviate. Monitors have actively reviewed the subjects' medical records for Adverse Events during monitor visits.
General disorders Death	0.83% 1/120 • Number of events 1 • 24 Months In this study, an Adverse Event (AE) is defined as any undesirable clinical event occurring in the abdominal space including the lower abdominal, inguinal and pubic regions (including the skin), as well as any other undesirable clinical events judged to be related to the study device or surgical procedure regardless of anatomical region. The definition of Serious AE does not deviate. Monitors have actively reviewed the subjects' medical records for Adverse Events during monitor visits.
General disorders Pain	0.83% 1/120 • Number of events 1 • 24 Months In this study, an Adverse Event (AE) is defined as any undesirable clinical event occurring in the abdominal space including the lower abdominal, inguinal and pubic regions (including the skin), as well as any other undesirable clinical events judged to be related to the study device or surgical procedure regardless of anatomical region. The definition of Serious AE does not deviate. Monitors have actively reviewed the subjects' medical records for Adverse Events during monitor visits.
Hepatobiliary disorders Cholecystitis	0.83% 1/120 • Number of events 1 • 24 Months In this study, an Adverse Event (AE) is defined as any undesirable clinical event occurring in the abdominal space including the lower abdominal, inguinal and pubic regions (including the skin), as well as any other undesirable clinical events judged to be related to the study device or surgical procedure regardless of anatomical region. The definition of Serious AE does not deviate. Monitors have actively reviewed the subjects' medical records for Adverse Events during monitor visits.
Infections and infestations Abdominal abscess	0.83% 1/120 • Number of events 1 • 24 Months In this study, an Adverse Event (AE) is defined as any undesirable clinical event occurring in the abdominal space including the lower abdominal, inguinal and pubic regions (including the skin), as well as any other undesirable clinical events judged to be related to the study device or surgical procedure regardless of anatomical region. The definition of Serious AE does not deviate. Monitors have actively reviewed the subjects' medical records for Adverse Events during monitor visits.
Infections and infestations Abdominal wall abscess	0.83% 1/120 • Number of events 1 • 24 Months In this study, an Adverse Event (AE) is defined as any undesirable clinical event occurring in the abdominal space including the lower abdominal, inguinal and pubic regions (including the skin), as well as any other undesirable clinical events judged to be related to the study device or surgical procedure regardless of anatomical region. The definition of Serious AE does not deviate. Monitors have actively reviewed the subjects' medical records for Adverse Events during monitor visits.
Infections and infestations Diverticulitis	0.83% 1/120 • Number of events 1 • 24 Months In this study, an Adverse Event (AE) is defined as any undesirable clinical event occurring in the abdominal space including the lower abdominal, inguinal and pubic regions (including the skin), as well as any other undesirable clinical events judged to be related to the study device or surgical procedure regardless of anatomical region. The definition of Serious AE does not deviate. Monitors have actively reviewed the subjects' medical records for Adverse Events during monitor visits.
Infections and infestations Infectious pleural effusion	0.83% 1/120 • Number of events 1 • 24 Months In this study, an Adverse Event (AE) is defined as any undesirable clinical event occurring in the abdominal space including the lower abdominal, inguinal and pubic regions (including the skin), as well as any other undesirable clinical events judged to be related to the study device or surgical procedure regardless of anatomical region. The definition of Serious AE does not deviate. Monitors have actively reviewed the subjects' medical records for Adverse Events during monitor visits.
Infections and infestations Pneumonia	0.83% 1/120 • Number of events 1 • 24 Months In this study, an Adverse Event (AE) is defined as any undesirable clinical event occurring in the abdominal space including the lower abdominal, inguinal and pubic regions (including the skin), as well as any other undesirable clinical events judged to be related to the study device or surgical procedure regardless of anatomical region. The definition of Serious AE does not deviate. Monitors have actively reviewed the subjects' medical records for Adverse Events during monitor visits.
Infections and infestations Sepsis	0.83% 1/120 • Number of events 1 • 24 Months In this study, an Adverse Event (AE) is defined as any undesirable clinical event occurring in the abdominal space including the lower abdominal, inguinal and pubic regions (including the skin), as well as any other undesirable clinical events judged to be related to the study device or surgical procedure regardless of anatomical region. The definition of Serious AE does not deviate. Monitors have actively reviewed the subjects' medical records for Adverse Events during monitor visits.
Injury, poisoning and procedural complications Accidental overdose	0.83% 1/120 • Number of events 1 • 24 Months In this study, an Adverse Event (AE) is defined as any undesirable clinical event occurring in the abdominal space including the lower abdominal, inguinal and pubic regions (including the skin), as well as any other undesirable clinical events judged to be related to the study device or surgical procedure regardless of anatomical region. The definition of Serious AE does not deviate. Monitors have actively reviewed the subjects' medical records for Adverse Events during monitor visits.
Injury, poisoning and procedural complications Incisional Hernia	18.3% 22/120 • Number of events 22 • 24 Months In this study, an Adverse Event (AE) is defined as any undesirable clinical event occurring in the abdominal space including the lower abdominal, inguinal and pubic regions (including the skin), as well as any other undesirable clinical events judged to be related to the study device or surgical procedure regardless of anatomical region. The definition of Serious AE does not deviate. Monitors have actively reviewed the subjects' medical records for Adverse Events during monitor visits.
Injury, poisoning and procedural complications Intentional Overdose	0.83% 1/120 • Number of events 1 • 24 Months In this study, an Adverse Event (AE) is defined as any undesirable clinical event occurring in the abdominal space including the lower abdominal, inguinal and pubic regions (including the skin), as well as any other undesirable clinical events judged to be related to the study device or surgical procedure regardless of anatomical region. The definition of Serious AE does not deviate. Monitors have actively reviewed the subjects' medical records for Adverse Events during monitor visits.
Injury, poisoning and procedural complications Joint Injury	0.83% 1/120 • Number of events 1 • 24 Months In this study, an Adverse Event (AE) is defined as any undesirable clinical event occurring in the abdominal space including the lower abdominal, inguinal and pubic regions (including the skin), as well as any other undesirable clinical events judged to be related to the study device or surgical procedure regardless of anatomical region. The definition of Serious AE does not deviate. Monitors have actively reviewed the subjects' medical records for Adverse Events during monitor visits.
Injury, poisoning and procedural complications Post procedural haematoma	0.83% 1/120 • Number of events 1 • 24 Months In this study, an Adverse Event (AE) is defined as any undesirable clinical event occurring in the abdominal space including the lower abdominal, inguinal and pubic regions (including the skin), as well as any other undesirable clinical events judged to be related to the study device or surgical procedure regardless of anatomical region. The definition of Serious AE does not deviate. Monitors have actively reviewed the subjects' medical records for Adverse Events during monitor visits.
Injury, poisoning and procedural complications Postoperative ileus	3.3% 4/120 • Number of events 4 • 24 Months In this study, an Adverse Event (AE) is defined as any undesirable clinical event occurring in the abdominal space including the lower abdominal, inguinal and pubic regions (including the skin), as well as any other undesirable clinical events judged to be related to the study device or surgical procedure regardless of anatomical region. The definition of Serious AE does not deviate. Monitors have actively reviewed the subjects' medical records for Adverse Events during monitor visits.
Injury, poisoning and procedural complications Procedural pain	1.7% 2/120 • Number of events 2 • 24 Months In this study, an Adverse Event (AE) is defined as any undesirable clinical event occurring in the abdominal space including the lower abdominal, inguinal and pubic regions (including the skin), as well as any other undesirable clinical events judged to be related to the study device or surgical procedure regardless of anatomical region. The definition of Serious AE does not deviate. Monitors have actively reviewed the subjects' medical records for Adverse Events during monitor visits.
Injury, poisoning and procedural complications Rib Fracture	0.83% 1/120 • Number of events 1 • 24 Months In this study, an Adverse Event (AE) is defined as any undesirable clinical event occurring in the abdominal space including the lower abdominal, inguinal and pubic regions (including the skin), as well as any other undesirable clinical events judged to be related to the study device or surgical procedure regardless of anatomical region. The definition of Serious AE does not deviate. Monitors have actively reviewed the subjects' medical records for Adverse Events during monitor visits.
Injury, poisoning and procedural complications Subdural haematoma	0.83% 1/120 • Number of events 1 • 24 Months In this study, an Adverse Event (AE) is defined as any undesirable clinical event occurring in the abdominal space including the lower abdominal, inguinal and pubic regions (including the skin), as well as any other undesirable clinical events judged to be related to the study device or surgical procedure regardless of anatomical region. The definition of Serious AE does not deviate. Monitors have actively reviewed the subjects' medical records for Adverse Events during monitor visits.
Injury, poisoning and procedural complications Thermal burn	0.83% 1/120 • Number of events 1 • 24 Months In this study, an Adverse Event (AE) is defined as any undesirable clinical event occurring in the abdominal space including the lower abdominal, inguinal and pubic regions (including the skin), as well as any other undesirable clinical events judged to be related to the study device or surgical procedure regardless of anatomical region. The definition of Serious AE does not deviate. Monitors have actively reviewed the subjects' medical records for Adverse Events during monitor visits.
Metabolism and nutrition disorders Hyponatraemia	0.83% 1/120 • Number of events 1 • 24 Months In this study, an Adverse Event (AE) is defined as any undesirable clinical event occurring in the abdominal space including the lower abdominal, inguinal and pubic regions (including the skin), as well as any other undesirable clinical events judged to be related to the study device or surgical procedure regardless of anatomical region. The definition of Serious AE does not deviate. Monitors have actively reviewed the subjects' medical records for Adverse Events during monitor visits.
Musculoskeletal and connective tissue disorders Cervical spinal stenosis	0.83% 1/120 • Number of events 1 • 24 Months In this study, an Adverse Event (AE) is defined as any undesirable clinical event occurring in the abdominal space including the lower abdominal, inguinal and pubic regions (including the skin), as well as any other undesirable clinical events judged to be related to the study device or surgical procedure regardless of anatomical region. The definition of Serious AE does not deviate. Monitors have actively reviewed the subjects' medical records for Adverse Events during monitor visits.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cholangiocarcinoma	0.83% 1/120 • Number of events 1 • 24 Months In this study, an Adverse Event (AE) is defined as any undesirable clinical event occurring in the abdominal space including the lower abdominal, inguinal and pubic regions (including the skin), as well as any other undesirable clinical events judged to be related to the study device or surgical procedure regardless of anatomical region. The definition of Serious AE does not deviate. Monitors have actively reviewed the subjects' medical records for Adverse Events during monitor visits.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Small intestine carcinoma	0.83% 1/120 • Number of events 1 • 24 Months In this study, an Adverse Event (AE) is defined as any undesirable clinical event occurring in the abdominal space including the lower abdominal, inguinal and pubic regions (including the skin), as well as any other undesirable clinical events judged to be related to the study device or surgical procedure regardless of anatomical region. The definition of Serious AE does not deviate. Monitors have actively reviewed the subjects' medical records for Adverse Events during monitor visits.
Nervous system disorders Syncope	0.83% 1/120 • Number of events 1 • 24 Months In this study, an Adverse Event (AE) is defined as any undesirable clinical event occurring in the abdominal space including the lower abdominal, inguinal and pubic regions (including the skin), as well as any other undesirable clinical events judged to be related to the study device or surgical procedure regardless of anatomical region. The definition of Serious AE does not deviate. Monitors have actively reviewed the subjects' medical records for Adverse Events during monitor visits.
Nervous system disorders Ulnar neuritis	0.83% 1/120 • Number of events 1 • 24 Months In this study, an Adverse Event (AE) is defined as any undesirable clinical event occurring in the abdominal space including the lower abdominal, inguinal and pubic regions (including the skin), as well as any other undesirable clinical events judged to be related to the study device or surgical procedure regardless of anatomical region. The definition of Serious AE does not deviate. Monitors have actively reviewed the subjects' medical records for Adverse Events during monitor visits.
Reproductive system and breast disorders Pelvic adhesions	0.83% 1/120 • Number of events 1 • 24 Months In this study, an Adverse Event (AE) is defined as any undesirable clinical event occurring in the abdominal space including the lower abdominal, inguinal and pubic regions (including the skin), as well as any other undesirable clinical events judged to be related to the study device or surgical procedure regardless of anatomical region. The definition of Serious AE does not deviate. Monitors have actively reviewed the subjects' medical records for Adverse Events during monitor visits.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.83% 1/120 • Number of events 1 • 24 Months In this study, an Adverse Event (AE) is defined as any undesirable clinical event occurring in the abdominal space including the lower abdominal, inguinal and pubic regions (including the skin), as well as any other undesirable clinical events judged to be related to the study device or surgical procedure regardless of anatomical region. The definition of Serious AE does not deviate. Monitors have actively reviewed the subjects' medical records for Adverse Events during monitor visits.
Vascular disorders Hypertensive crisis	0.83% 1/120 • Number of events 1 • 24 Months In this study, an Adverse Event (AE) is defined as any undesirable clinical event occurring in the abdominal space including the lower abdominal, inguinal and pubic regions (including the skin), as well as any other undesirable clinical events judged to be related to the study device or surgical procedure regardless of anatomical region. The definition of Serious AE does not deviate. Monitors have actively reviewed the subjects' medical records for Adverse Events during monitor visits.
Vascular disorders Hypotension	0.83% 1/120 • Number of events 1 • 24 Months In this study, an Adverse Event (AE) is defined as any undesirable clinical event occurring in the abdominal space including the lower abdominal, inguinal and pubic regions (including the skin), as well as any other undesirable clinical events judged to be related to the study device or surgical procedure regardless of anatomical region. The definition of Serious AE does not deviate. Monitors have actively reviewed the subjects' medical records for Adverse Events during monitor visits.
Vascular disorders Peripheral arterial occlusive disease	0.83% 1/120 • Number of events 1 • 24 Months In this study, an Adverse Event (AE) is defined as any undesirable clinical event occurring in the abdominal space including the lower abdominal, inguinal and pubic regions (including the skin), as well as any other undesirable clinical events judged to be related to the study device or surgical procedure regardless of anatomical region. The definition of Serious AE does not deviate. Monitors have actively reviewed the subjects' medical records for Adverse Events during monitor visits.

Other adverse events

Other adverse events
Measure	Phasix™ ST n=120 participants at risk Subjects treated with Phasix™ ST mesh Phasix™ ST: Phasix™ ST is a fully resorbable mesh with a hydrogel coating that is also resorbable.
Gastrointestinal disorders Abdominal Pain	6.7% 8/120 • Number of events 120 • 24 Months In this study, an Adverse Event (AE) is defined as any undesirable clinical event occurring in the abdominal space including the lower abdominal, inguinal and pubic regions (including the skin), as well as any other undesirable clinical events judged to be related to the study device or surgical procedure regardless of anatomical region. The definition of Serious AE does not deviate. Monitors have actively reviewed the subjects' medical records for Adverse Events during monitor visits.
Gastrointestinal disorders Abdominal pain upper	2.5% 3/120 • Number of events 3 • 24 Months In this study, an Adverse Event (AE) is defined as any undesirable clinical event occurring in the abdominal space including the lower abdominal, inguinal and pubic regions (including the skin), as well as any other undesirable clinical events judged to be related to the study device or surgical procedure regardless of anatomical region. The definition of Serious AE does not deviate. Monitors have actively reviewed the subjects' medical records for Adverse Events during monitor visits.
Injury, poisoning and procedural complications Incisional hernia	14.2% 17/120 • Number of events 17 • 24 Months In this study, an Adverse Event (AE) is defined as any undesirable clinical event occurring in the abdominal space including the lower abdominal, inguinal and pubic regions (including the skin), as well as any other undesirable clinical events judged to be related to the study device or surgical procedure regardless of anatomical region. The definition of Serious AE does not deviate. Monitors have actively reviewed the subjects' medical records for Adverse Events during monitor visits.
Injury, poisoning and procedural complications Procedural Pain	14.2% 17/120 • Number of events 17 • 24 Months In this study, an Adverse Event (AE) is defined as any undesirable clinical event occurring in the abdominal space including the lower abdominal, inguinal and pubic regions (including the skin), as well as any other undesirable clinical events judged to be related to the study device or surgical procedure regardless of anatomical region. The definition of Serious AE does not deviate. Monitors have actively reviewed the subjects' medical records for Adverse Events during monitor visits.
Injury, poisoning and procedural complications Seroma	7.5% 9/120 • Number of events 9 • 24 Months In this study, an Adverse Event (AE) is defined as any undesirable clinical event occurring in the abdominal space including the lower abdominal, inguinal and pubic regions (including the skin), as well as any other undesirable clinical events judged to be related to the study device or surgical procedure regardless of anatomical region. The definition of Serious AE does not deviate. Monitors have actively reviewed the subjects' medical records for Adverse Events during monitor visits.
Injury, poisoning and procedural complications Urinary retention postoperative	5.8% 7/120 • Number of events 7 • 24 Months In this study, an Adverse Event (AE) is defined as any undesirable clinical event occurring in the abdominal space including the lower abdominal, inguinal and pubic regions (including the skin), as well as any other undesirable clinical events judged to be related to the study device or surgical procedure regardless of anatomical region. The definition of Serious AE does not deviate. Monitors have actively reviewed the subjects' medical records for Adverse Events during monitor visits.
Musculoskeletal and connective tissue disorders Diastasis recti abdominis	2.5% 3/120 • Number of events 3 • 24 Months In this study, an Adverse Event (AE) is defined as any undesirable clinical event occurring in the abdominal space including the lower abdominal, inguinal and pubic regions (including the skin), as well as any other undesirable clinical events judged to be related to the study device or surgical procedure regardless of anatomical region. The definition of Serious AE does not deviate. Monitors have actively reviewed the subjects' medical records for Adverse Events during monitor visits.

Additional Information

Dawn Heimer / Sr. Director Medical Affairs

Becton Dickinson

Phone: 401-479-1253

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place