Trial Outcomes & Findings for Ventral Hernia Study Using OviTex Reinforced Bioscaffold (NCT NCT03074474)

Last Updated: 2023-06-13

Results Overview

The primary endpoints were number of participants experiencing an SSO or wound related event at the hernia repair site and the number of participants experiencing other complications \<90 days after index surgery. These included seromas, hematomas, wound dehiscence, skin necrosis, fistulae, and infections. Complications such as ileus and bowel obstruction were also recorded.

Recruitment status

COMPLETED

Study phase

Target enrollment

92 participants

Primary outcome timeframe

within the first three months of the ventral hernia repair

Results posted on

2023-06-13

Participant Flow

Of 95 patients were consented, 3 did not meet eligibility criteria and were not enrolled. Only 92 patients were enrolled in the study and received OviTex 1S Permanent reinforced tissue matrix during their hernia repair procedure.

Participant milestones

Participant milestones
Measure	OviTex Permanent 1S All subjects included in this post-market study had a ventral hernia repaired with OviTex 1S Permanent reinforced tissue matrix.
Overall Study STARTED	92
Overall Study COMPLETED	65
Overall Study NOT COMPLETED	27

Reasons for withdrawal

Reasons for withdrawal
Measure	OviTex Permanent 1S All subjects included in this post-market study had a ventral hernia repaired with OviTex 1S Permanent reinforced tissue matrix.
Overall Study Lost to Follow-up	10
Overall Study Withdrawal by Subject	10
Overall Study Death	4
Overall Study 1 exited due to recurrence and 2 exited due to mesh removal.	3

Baseline Characteristics

Ventral Hernia Study Using OviTex Reinforced Bioscaffold

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	OviTex Permanent 1S n=92 Participants All subjects included in this post-market study had a ventral hernia repaired with OviTex 1S Permanent reinforced tissue matrix.
Age, Customized Age	60.42 years STANDARD_DEVIATION 13.13 • n=93 Participants
Sex: Female, Male Female	55 Participants n=93 Participants
Sex: Female, Male Male	37 Participants n=93 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=93 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	91 Participants n=93 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants
Race (NIH/OMB) Asian	1 Participants n=93 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants
Race (NIH/OMB) Black or African American	3 Participants n=93 Participants
Race (NIH/OMB) White	88 Participants n=93 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Body Mass Index	31 (kg/m^2) STANDARD_DEVIATION 4.51 • n=93 Participants
modified Ventral Hernia Working Group Grade Grade I	21 Participants n=93 Participants
modified Ventral Hernia Working Group Grade Grade II	52 Participants n=93 Participants
modified Ventral Hernia Working Group Grade Grade III	19 Participants n=93 Participants
Surgical Site Wound Classification CDC Class I Clean	74 Participants n=93 Participants
Surgical Site Wound Classification CDC Class II Clean-Contaminated	14 Participants n=93 Participants
Surgical Site Wound Classification CDC Class III Contaminated	4 Participants n=93 Participants
Operative Approach Open	60 Participants n=93 Participants
Operative Approach Laparoscopic	12 Participants n=93 Participants
Operative Approach Robotic	20 Participants n=93 Participants
Plane of Placement Retrorectus/TAR	48 Participants n=93 Participants
Plane of Placement Intraperitoneal	42 Participants n=93 Participants
Plane of Placement Retrofascial/Pre-Periotneal	1 Participants n=93 Participants
Plane of Placement Onlay	1 Participants n=93 Participants

PRIMARY outcome

Timeframe: within the first three months of the ventral hernia repair

Outcome measures

Outcome measures
Measure	OviTex 1S Permanent n=92 Participants All subjects included in this post-market study had a ventral hernia repaired with OviTex 1S Permanent reinforced tissue matrix.
Surgical Site Occurrences or Wound-related Events Seroma (requiring intervention)	3 Participants
Surgical Site Occurrences or Wound-related Events Skin Necrosis	1 Participants
Surgical Site Occurrences or Wound-related Events Adjacent Recurrence	0 Participants
Surgical Site Occurrences or Wound-related Events Seroma	10 Participants
Surgical Site Occurrences or Wound-related Events Hematoma	4 Participants
Surgical Site Occurrences or Wound-related Events Wound Dehiscence	1 Participants
Surgical Site Occurrences or Wound-related Events Fistulae	2 Participants
Surgical Site Occurrences or Wound-related Events Surgical Site Infection	15 Participants
Surgical Site Occurrences or Wound-related Events Bowel Obstruction	1 Participants
Surgical Site Occurrences or Wound-related Events Ileus	8 Participants
Surgical Site Occurrences or Wound-related Events Any other non-surgery or hernia-related complications	1 Participants
Surgical Site Occurrences or Wound-related Events Mesh Removal (Full)	1 Participants
Surgical Site Occurrences or Wound-related Events Mesh Removal (Partial)	1 Participants
Surgical Site Occurrences or Wound-related Events Superficial Infection	9 Participants
Surgical Site Occurrences or Wound-related Events Deep/Abscess Infection	6 Participants
Surgical Site Occurrences or Wound-related Events Organ Space Infection	0 Participants

SECONDARY outcome

Timeframe: Overall Cumulative SSOs and Complications (0 - 24 Months)

Secondary outcome measures include the number of participants experiencing a hernia recurrence, post-operative SSO, wound related event at the hernia repair site, and other complications occurring at time points \> 90 days after index surgery.

Outcome measures

Outcome measures
Measure	OviTex 1S Permanent n=92 Participants All subjects included in this post-market study had a ventral hernia repaired with OviTex 1S Permanent reinforced tissue matrix.
Hernia Recurrence, Post-operative SSO, and Wound Related Events at the Hernia Repair Site Occurring at Time Points > 90 Days After Index Surgery Adjacent Recurrence	3 Participants
Hernia Recurrence, Post-operative SSO, and Wound Related Events at the Hernia Repair Site Occurring at Time Points > 90 Days After Index Surgery Seroma (requiring intervention)	3 Participants
Hernia Recurrence, Post-operative SSO, and Wound Related Events at the Hernia Repair Site Occurring at Time Points > 90 Days After Index Surgery Bowel Obstruction	1 Participants
Hernia Recurrence, Post-operative SSO, and Wound Related Events at the Hernia Repair Site Occurring at Time Points > 90 Days After Index Surgery Ileus	8 Participants
Hernia Recurrence, Post-operative SSO, and Wound Related Events at the Hernia Repair Site Occurring at Time Points > 90 Days After Index Surgery Any other non-surgery or hernia-related complication	2 Participants
Hernia Recurrence, Post-operative SSO, and Wound Related Events at the Hernia Repair Site Occurring at Time Points > 90 Days After Index Surgery Mesh removal (full)	2 Participants
Hernia Recurrence, Post-operative SSO, and Wound Related Events at the Hernia Repair Site Occurring at Time Points > 90 Days After Index Surgery Seroma	12 Participants
Hernia Recurrence, Post-operative SSO, and Wound Related Events at the Hernia Repair Site Occurring at Time Points > 90 Days After Index Surgery Hematoma	4 Participants
Hernia Recurrence, Post-operative SSO, and Wound Related Events at the Hernia Repair Site Occurring at Time Points > 90 Days After Index Surgery Wound Dehiscence	1 Participants
Hernia Recurrence, Post-operative SSO, and Wound Related Events at the Hernia Repair Site Occurring at Time Points > 90 Days After Index Surgery Skin Necrosis	1 Participants
Hernia Recurrence, Post-operative SSO, and Wound Related Events at the Hernia Repair Site Occurring at Time Points > 90 Days After Index Surgery Fistulae	2 Participants
Hernia Recurrence, Post-operative SSO, and Wound Related Events at the Hernia Repair Site Occurring at Time Points > 90 Days After Index Surgery SSI	19 Participants
Hernia Recurrence, Post-operative SSO, and Wound Related Events at the Hernia Repair Site Occurring at Time Points > 90 Days After Index Surgery Mesh removal (partial)	1 Participants

SECONDARY outcome

Timeframe: Baseline through 24 months

Population: The number of participants at each time point differs from the overall number of participants analyzed (92) as not all participants completed the required questionnaires at each time point and therefore, only the questionnaires that were available to be analyzed are included.

Hernia-Related Quality-of-Life Survey (HerQLes) assesses abdominal wall function and impact of ventral hernia repair on quality of life through 12 questions. Responses are graded on a likert scale from 1 to 6, 1=strongly disagree, 2=moderately disagree, 3=slightly disagree, 4=slightly agree, 5=moderately agree, 6=strongly agree. A raw score is calculated by the following formula: 12 question average = (Response to Q1 + Response to Q2 +…+ Response to Q12) / 12 A summary score is calculated by the following formula: HerQLes Summary Score = 120-20\*(12 Question Average) HerQLes scores range from 0 (worst possible response) to 100 (best possible response). Data is reported as change in HerQLes Summary Score from baseline to each time point The scale was first reported in Krpata, D. M. et al. Design and Initial Implementation of HerQLes: A Hernia-Related Quality-of-Life Survey to Assess Abdominal Wall Function. J Am Coll Surgeons 215, 635-642 (2012).

Outcome measures

Outcome measures
Measure	OviTex 1S Permanent n=92 Participants All subjects included in this post-market study had a ventral hernia repaired with OviTex 1S Permanent reinforced tissue matrix.
Change in Patient Reported Outcomes (HerQLes) From Baseline to Each Time Point Day 30	-5.67 scores on a scale Standard Deviation 31.62
Change in Patient Reported Outcomes (HerQLes) From Baseline to Each Time Point Day 90	16.25 scores on a scale Standard Deviation 31.12
Change in Patient Reported Outcomes (HerQLes) From Baseline to Each Time Point Month 12	25.03 scores on a scale Standard Deviation 30.09
Change in Patient Reported Outcomes (HerQLes) From Baseline to Each Time Point Month 24	26.93 scores on a scale Standard Deviation 29.01

SECONDARY outcome

Timeframe: Baseline through 24 Months

EuroQol 5 Dimensions (EQ-5D) Visual Analog Scale (VAS) is a standardized generic (disease non-specific) quality of life scale measuring how good or bad the patients' health is on their visit date. The patient indicates on the scale from 0 (the worst health you can imagine) to 100 (the best health you can imagine) how their health is with an X and reports the number in a box. Data is reported as change in EQ-5D VAS score from baseline to each time point.

Outcome measures

Outcome measures
Measure	OviTex 1S Permanent n=92 Participants All subjects included in this post-market study had a ventral hernia repaired with OviTex 1S Permanent reinforced tissue matrix.
Change in Patient Reported Outcomes (EQ-5D VAS) From Baseline to Each Time Point Day 30	-0.05 scores on a scale Standard Deviation 19.49
Change in Patient Reported Outcomes (EQ-5D VAS) From Baseline to Each Time Point Day 90	0.49 scores on a scale Standard Deviation 21.21
Change in Patient Reported Outcomes (EQ-5D VAS) From Baseline to Each Time Point Month 12	6.70 scores on a scale Standard Deviation 20.48
Change in Patient Reported Outcomes (EQ-5D VAS) From Baseline to Each Time Point Month 24	5.28 scores on a scale Standard Deviation 18.97

SECONDARY outcome

Timeframe: Baseline through 24 Months

EuroQol 5 Dimensions (EQ-5D) is a standardized generic (disease non-specific) quality of life instrument measuring mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Responses are coded from 1 to 5 (1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems, 5=extreme problems). The levels reported for each dimension create a 5-digit number (i.e. 11111 or 12345) based on patient response. These 5-digit numbers are converted to an index score by special algorithm that is not publicly available. The index value represents the patient's health status, where higher numbers are associated with better outcomes. Data is reported as change in EQ-5D Index value from baseline to each time point.

Outcome measures

Outcome measures
Measure	OviTex 1S Permanent n=92 Participants All subjects included in this post-market study had a ventral hernia repaired with OviTex 1S Permanent reinforced tissue matrix.
Change in Patient Reported Outcomes (EQ-5D Index) From Baseline to Each Time Point Day 30	-0.048 scores on a scale Standard Deviation 0.150
Change in Patient Reported Outcomes (EQ-5D Index) From Baseline to Each Time Point Day 90	0.006 scores on a scale Standard Deviation 0.164
Change in Patient Reported Outcomes (EQ-5D Index) From Baseline to Each Time Point Month 12	0.046 scores on a scale Standard Deviation 0.142
Change in Patient Reported Outcomes (EQ-5D Index) From Baseline to Each Time Point Month 24	0.042 scores on a scale Standard Deviation 0.129

Adverse Events

OviTex 1S Permanent

Serious events: 34 serious events

Other events: 24 other events

Deaths: 4 deaths

Serious adverse events

Serious adverse events
Measure	OviTex 1S Permanent n=92 participants at risk All subjects included in this post-market study will have a ventral hernia repaired with OviTex 1S Permanent reinforced tissue matrix.
Cardiac disorders Atrial fibrillation	2.2% 2/92 • Number of events 2 • Adverse events were collected from all study subjects from the time of the index surgery through the 24 month follow-up.
Cardiac disorders Cardiac arrest	1.1% 1/92 • Number of events 1 • Adverse events were collected from all study subjects from the time of the index surgery through the 24 month follow-up.
Cardiac disorders Cardio-respiratory arrest	2.2% 2/92 • Number of events 2 • Adverse events were collected from all study subjects from the time of the index surgery through the 24 month follow-up.
Cardiac disorders Pericardial effusion	1.1% 1/92 • Number of events 1 • Adverse events were collected from all study subjects from the time of the index surgery through the 24 month follow-up.
Gastrointestinal disorders Abdominal hernia	1.1% 1/92 • Number of events 1 • Adverse events were collected from all study subjects from the time of the index surgery through the 24 month follow-up.
Gastrointestinal disorders Constipation	1.1% 1/92 • Number of events 1 • Adverse events were collected from all study subjects from the time of the index surgery through the 24 month follow-up.
Gastrointestinal disorders Fistula of small intestine	2.2% 2/92 • Number of events 2 • Adverse events were collected from all study subjects from the time of the index surgery through the 24 month follow-up.
Gastrointestinal disorders Gastrointestinal haemorrhage	1.1% 1/92 • Number of events 2 • Adverse events were collected from all study subjects from the time of the index surgery through the 24 month follow-up.
Gastrointestinal disorders Haematemesis	1.1% 1/92 • Number of events 1 • Adverse events were collected from all study subjects from the time of the index surgery through the 24 month follow-up.
Gastrointestinal disorders Inguinal hernia	1.1% 1/92 • Number of events 1 • Adverse events were collected from all study subjects from the time of the index surgery through the 24 month follow-up.
Gastrointestinal disorders Intestinal fistula	1.1% 1/92 • Number of events 1 • Adverse events were collected from all study subjects from the time of the index surgery through the 24 month follow-up.
Gastrointestinal disorders Rectal prolapse	1.1% 1/92 • Number of events 1 • Adverse events were collected from all study subjects from the time of the index surgery through the 24 month follow-up.
Gastrointestinal disorders Small intestinal obstruction	1.1% 1/92 • Number of events 1 • Adverse events were collected from all study subjects from the time of the index surgery through the 24 month follow-up.
Gastrointestinal disorders Vomiting	1.1% 1/92 • Number of events 1 • Adverse events were collected from all study subjects from the time of the index surgery through the 24 month follow-up.
Hepatobiliary disorders Cirrhosis alcoholic	1.1% 1/92 • Number of events 1 • Adverse events were collected from all study subjects from the time of the index surgery through the 24 month follow-up.
Infections and infestations Abdominal abscess	1.1% 1/92 • Number of events 1 • Adverse events were collected from all study subjects from the time of the index surgery through the 24 month follow-up.
Infections and infestations Abdominal wall abscess	5.4% 5/92 • Number of events 6 • Adverse events were collected from all study subjects from the time of the index surgery through the 24 month follow-up.
Infections and infestations Incision site abscess	1.1% 1/92 • Number of events 1 • Adverse events were collected from all study subjects from the time of the index surgery through the 24 month follow-up.
Infections and infestations Pelvic abscess	1.1% 1/92 • Number of events 1 • Adverse events were collected from all study subjects from the time of the index surgery through the 24 month follow-up.
Infections and infestations Pneumonia	1.1% 1/92 • Number of events 1 • Adverse events were collected from all study subjects from the time of the index surgery through the 24 month follow-up.
Infections and infestations Postoperative wound infection	1.1% 1/92 • Number of events 1 • Adverse events were collected from all study subjects from the time of the index surgery through the 24 month follow-up.
Infections and infestations Sepsis	1.1% 1/92 • Number of events 1 • Adverse events were collected from all study subjects from the time of the index surgery through the 24 month follow-up.
Infections and infestations Subdiaphragmatic abscess	1.1% 1/92 • Number of events 1 • Adverse events were collected from all study subjects from the time of the index surgery through the 24 month follow-up.
Injury, poisoning and procedural complications Complications of transplanted liver	1.1% 1/92 • Number of events 1 • Adverse events were collected from all study subjects from the time of the index surgery through the 24 month follow-up.
Injury, poisoning and procedural complications Incarcerated incisional hernia	1.1% 1/92 • Number of events 1 • Adverse events were collected from all study subjects from the time of the index surgery through the 24 month follow-up.
Injury, poisoning and procedural complications Incisional hernia	1.1% 1/92 • Number of events 1 • Adverse events were collected from all study subjects from the time of the index surgery through the 24 month follow-up.
Injury, poisoning and procedural complications Post procedural haematoma	1.1% 1/92 • Number of events 1 • Adverse events were collected from all study subjects from the time of the index surgery through the 24 month follow-up.
Injury, poisoning and procedural complications Postoperative ileus	1.1% 1/92 • Number of events 1 • Adverse events were collected from all study subjects from the time of the index surgery through the 24 month follow-up.
Injury, poisoning and procedural complications Postoperative wound complication	1.1% 1/92 • Number of events 1 • Adverse events were collected from all study subjects from the time of the index surgery through the 24 month follow-up.
Injury, poisoning and procedural complications Procedural pain	1.1% 1/92 • Number of events 1 • Adverse events were collected from all study subjects from the time of the index surgery through the 24 month follow-up.
Injury, poisoning and procedural complications Seroma	1.1% 1/92 • Number of events 1 • Adverse events were collected from all study subjects from the time of the index surgery through the 24 month follow-up.
Metabolism and nutrition disorders Dehydration	1.1% 1/92 • Number of events 1 • Adverse events were collected from all study subjects from the time of the index surgery through the 24 month follow-up.
Metabolism and nutrition disorders Hyponatraemia	1.1% 1/92 • Number of events 1 • Adverse events were collected from all study subjects from the time of the index surgery through the 24 month follow-up.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung carcinoma cell type unspecified stage IV	1.1% 1/92 • Number of events 1 • Adverse events were collected from all study subjects from the time of the index surgery through the 24 month follow-up.
Nervous system disorders Cerebrovascular accident	1.1% 1/92 • Number of events 1 • Adverse events were collected from all study subjects from the time of the index surgery through the 24 month follow-up.
Nervous system disorders Presyncope	1.1% 1/92 • Number of events 1 • Adverse events were collected from all study subjects from the time of the index surgery through the 24 month follow-up.
Renal and urinary disorders Acute kidney injury	1.1% 1/92 • Number of events 1 • Adverse events were collected from all study subjects from the time of the index surgery through the 24 month follow-up.
Reproductive system and breast disorders Uterovaginal prolapse	1.1% 1/92 • Number of events 1 • Adverse events were collected from all study subjects from the time of the index surgery through the 24 month follow-up.
Respiratory, thoracic and mediastinal disorders Aspiration	1.1% 1/92 • Number of events 1 • Adverse events were collected from all study subjects from the time of the index surgery through the 24 month follow-up.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	1.1% 1/92 • Number of events 1 • Adverse events were collected from all study subjects from the time of the index surgery through the 24 month follow-up.
Respiratory, thoracic and mediastinal disorders Hypercapnia	1.1% 1/92 • Number of events 1 • Adverse events were collected from all study subjects from the time of the index surgery through the 24 month follow-up.
Respiratory, thoracic and mediastinal disorders Hypoxia	1.1% 1/92 • Number of events 1 • Adverse events were collected from all study subjects from the time of the index surgery through the 24 month follow-up.
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	1.1% 1/92 • Number of events 1 • Adverse events were collected from all study subjects from the time of the index surgery through the 24 month follow-up.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	1.1% 1/92 • Number of events 1 • Adverse events were collected from all study subjects from the time of the index surgery through the 24 month follow-up.

Other adverse events

Other adverse events
Measure	OviTex 1S Permanent n=92 participants at risk All subjects included in this post-market study will have a ventral hernia repaired with OviTex 1S Permanent reinforced tissue matrix.
Gastrointestinal disorders Constipation	7.6% 7/92 • Number of events 8 • Adverse events were collected from all study subjects from the time of the index surgery through the 24 month follow-up.
Gastrointestinal disorders Nausea	6.5% 6/92 • Number of events 7 • Adverse events were collected from all study subjects from the time of the index surgery through the 24 month follow-up.
General disorders Pyrexia	5.4% 5/92 • Number of events 5 • Adverse events were collected from all study subjects from the time of the index surgery through the 24 month follow-up.
Injury, poisoning and procedural complications Seroma	13.0% 12/92 • Number of events 12 • Adverse events were collected from all study subjects from the time of the index surgery through the 24 month follow-up.

Additional Information

Neal Overbeck

TELA Bio

Phone: 484-802-9570

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place