Ventral Hernia Study Using OviTex Reinforced Bioscaffold

A Prospective, Single Arm, Multi-center Study Evaluating the Short-term Clinical Outcomes of Ventral Hernias Treated With OviTex Reinforced Bioscaffold.

The study is designed to demonstrate that the use of OviTex® 1S material for a ventral hernia repair leads to the same or a lower percentage of early post-operative complications and true hernia recurrences when compared to other types of available meshes. 100 subjects will be included from 5-7 participating investigator sites. Within 30 days prior to the hernia repair surgery, a baseline visit will be performed during which the patient's eligibility for the study will be evaluated. The surgical technique used for the repair will be determined by the investigator/surgeon. Additional study data will be collected during the hospital stay, 30 and 90 days post-operatively and 12 and 24 months post-operatively. At the follow up visits, the surgical site will be evaluated by the surgeon, both the surgeon and patient will be asked to rate their satisfaction with the repair and the subject will be asked to complete two Quality of Life questionnaires.

Study Overview

• Status: Completed
• Conditions: Hernia, Ventral
• Intervention / Treatment: Device: OviTex 1S Permanent

Detailed Description

The study is intended to evaluate the post-operative complications and re-herniations following the use of OviTex® Permanent 1S reinforced bioscaffold in subjects with ventral hernias. The study is designed to mirror surgical standard of care for ventral hernia intervention, with the exception of asking for subjects to return for evaluation at longer time points post-surgery than is typical for standard care. A baseline visit will be performed for patients who are identified for and provide informed consent to participate in the study. During this visit, a review of medical history, a physical exam and assessment of the hernia site will be performed. The potential subject will also be asked to complete two quality of life surveys; one that is disease specific and one that is a standard method of health assessment. On the day of surgery, the ventral hernia will be repaired with the use of OviTex® 1S reinforced bioscaffold. Perioperative data will be collected and the surgeon will provide an assessment of the product's handling qualities. During the course of the hospital stay, the subject will be assessed for incidence of early post-operative surgical site wound events and complications, all necessary medical interventions and/or re-operations. On the day of discharge, surgical site occurrences or wound related events noted at the hernia repair site and the occurrence of other post-operative complications will be assessed.

The Day 30 and Day 90 visits will have a visit window of +/- 2 weeks. At these visits, the incidence of late surgical site occurrences or wound related events noted at the hernia repair site will be assessed. If hernia recurrence is suspected, it will be confirmed via diagnostic imaging with a CT scan. The occurrence of other late post-operative complications will also be assessed. The subjects will be asked to complete the same disease specific questionnaire and the same health assessment questionnaire as was done at the Baseline visit, however the subject will also be asked to complete a pain assessment. Both the surgeon and the subject will provide an assessment of his/her satisfaction with the hernia repair. The activities at Months 12 and 24 mirror those of Days 30 and 90, however the visit window is extended to +/- 4 weeks.

• Study Type: Interventional
• Enrollment (Actual): 92
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • La Jolla, California, United States, 92037
      • Scripps Clinic
  • Florida
    • Sarasota, Florida, United States, 34239
      • Sarasota Memorial Hospital
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Indiana University School of Medicine
  • Kansas
    • Overland Park, Kansas, United States, 66213
      • St. Luke's Hospital South
  • New Jersey
    • Trenton, New Jersey, United States, 08638
      • Capital Health
  • New York
    • Roslyn, New York, United States, 11576
      • St. Francis Hosptial
  • Oklahoma
    • Lawton, Oklahoma, United States, 73505
      • Comanche County Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Subject suffers from an uncomplicated ventral hernia that requires surgical repair (open, laparoscopic, or robotic) with the use of an implant to reinforce or replace weakened or missing tissue.
• The size of the implant needed for repair is expected to be 18 x 22 cm, 20 x 20 cm or less.
• Subject meets CDC/SSI Wound Classification Class I (Clean), Class II (Clean-Contaminated) or Class III (Contaminated) criteria
• Subject is willing and able to sign an informed consent for the study and has signed the IRB approved Informed Consent form for this study.
• Subject is able to complete Quality of Life (QoL) and pain Questionnaires.
• Subject is at least 18 years old (or considered an adult per state law).
• Subject is able to participate fully in, and for the full duration of, the study.

Exclusion Criteria:

• Subject has a BMI of > 40.
• Subject meets CDC/SSI Wound Classification Class IV(Dirty-Infected) criteria.
• Subject is female and is pregnant.
• Subject has a life expectancy of < 2 years making it unlikely that the subject will successfully achieve two-year follow-up.
• Subject has recent history of drug or alcohol abuse (in last 3 years).
• Subject has an allergy to ovine-derived products.
• Subject has participated in another clinical trial within the past 30 days or is currently involved in another clinical trial.
• Subject is unable to receive OviTex® Permanent 1S reinforced bioscaffold at the time of surgery.

Intra-operative Exclusion Criteria

• Subject requires implant that exceeds 18 x 22 cm or 20 x 20 cm.
• Subject unable to receive OviTex® Permanent 1S reinforced bioscaffold at time of surgery.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: OviTex Permanent 1S; All subjects included in this post-market study had a ventral hernia repaired with OviTex 1S Permanent reinforced tissue matrix.

Device: OviTex 1S Permanent; OviTex 1S Permanent is a reinforced tissue matrix consisting of layers of extra-cellular matrix derived from sheep stomachs. The layers are embroidered together with a monofilament polypropylene. One side of the mesh has blue polypropylene stitching, which provides a surface conducive to native tissue growth. The other side of the mesh is a smooth surface intended to minimize tissue attachment (adhesions).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Surgical Site Occurrences or Wound-related Events	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.	within the first three months of the ventral hernia repair

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hernia Recurrence, Post-operative SSO, and Wound Related Events at the Hernia Repair Site Occurring at Time Points > 90 Days After Index Surgery	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.	Overall Cumulative SSOs and Complications (0 - 24 Months)
Change in Patient Reported Outcomes (HerQLes) From Baseline to Each Time Point	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).	Baseline through 24 months
Change in Patient Reported Outcomes (EQ-5D VAS) From Baseline to Each Time Point	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.	Baseline through 24 Months
Change in Patient Reported Outcomes (EQ-5D Index) From Baseline to Each Time Point	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.	Baseline through 24 Months

Collaborators and Investigators

• Sponsor: Tela Bio Inc
• Investigators: Principal Investigator: George DeNoto, MD, Saint Francis Memorial Hospital

Publications and helpful links

General Publications

• DeNoto G 3rd, Ceppa EP, Pacella SJ, Sawyer M, Slayden G, Takata M, Tuma G, Yunis J. 24-Month results of the BRAVO study: A prospective, multi-center study evaluating the clinical outcomes of a ventral hernia cohort treated with OviTex(R) 1S permanent reinforced tissue matrix. Ann Med Surg (Lond). 2022 Sep 27;83:104745. doi: 10.1016/j.amsu.2022.104745. eCollection 2022 Nov.
• DeNoto G 3rd, Ceppa EP, Pacella SJ, Sawyer M, Slayden G, Takata M, Tuma G, Yunis J. A Prospective, Single Arm, Multi-Center Study Evaluating the Clinical Outcomes of Ventral Hernias Treated with OviTex(R) 1S Permanent Reinforced Tissue Matrix: The BRAVO Study 12-Month Analysis. J Clin Med. 2021 Oct 27;10(21):4998. doi: 10.3390/jcm10214998.

Study record dates

Study Major Dates

• Study Start (Actual): April 24, 2017
• Primary Completion (Actual): December 8, 2019
• Study Completion (Actual): August 8, 2021

Study Registration Dates

• First Submitted: March 3, 2017
• First Submitted That Met QC Criteria: March 3, 2017
• First Posted (Actual): March 8, 2017

Study Record Updates

• Last Update Posted (Actual): June 13, 2023
• Last Update Submitted That Met QC Criteria: June 12, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: use of mesh
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Hernia, Abdominal; Hernia; Hernia, Ventral
• Other Study ID Numbers: TB2016.01.01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No