The Use of Biologic Mesh vs Bioabsorbable Mesh During Ventral Hernia Repair in At-risk Patients

NCT01794338 | Terminated Results DMC FDA Device

• 1 other identifier: 09-12-02A
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluates the outcomes of patients who have been treated with Strattice or Gore Bio-A mesh for the repair of complicated abdominal wall hernias. The purpose of this study is to collect information and evaluate the outcome of your surgery. Synthetic (man made) mesh has been shown to provide durable long-term outcomes; however, this type of mesh should not be used in patients at risk of developing an infection. Therefore, to address the challenge of finding an artificial strengthening material to repair complicated hernias in patients that could potentially develop surgical infection, two types of non-permanent materials have been developed, including biologics and bioabsorbables. Biologic mesh is made of living tissue and bioabsorbable mesh is made of synthetic material that is gradually absorbed by the body over time. The purpose of this study is to allow surgeons to compare the postoperative course of patients associated with these two mesh types to decide which material will improve the outcomes of their patients with complicated abdominal wall defects. To date there is no evidence to suggest that either mesh type is superior or safer than the other.

Conditions

Ventral Hernia

Outcome Measures

Primary Outcomes (1)

• Hernia Recurrence

  Patients will undergo post-operative follow-up at 1 month, 6 months, and yearly for 3 years. Patients will receive reminders of their follow-up visits before each time period. At each visit, patients will be asked to fill out a short questionnaire (Form A and Form B) that will aid in assessing and documenting postoperative symptoms and quality of life. During each follow-up visit a board certified or board eligible surgeon, who is blinded with regard to the group assignment, will perform a physical examination to assess for the presence of a recurrent hernia, eventration and other findings detailed on Form C. Any signs of wound complications will be noted, including seroma formation, erythema, drainage, break in the skin, purulence or tenderness to palpation. If a recurrent hernia defect is identified on the physical examination, imaging studies will be performed as indicated. Once a hernia defect is found, further management options will be discussed with the patient.

  3 years

Study Arms (2)

Bio-A Arm

EXPERIMENTAL

Patients will receive underlay mesh tissue reinforcement followed by standard fascial closure with #1 PDS. As described by Dr. Stoppa10-12, the mesh will be secured via abdominal wall sutures. Additional full thickness sutures will be placed every 8 cm circumferentially. After securing the mesh in place, #1 PDS sutures will be used to close the fascia in a running fashion with 1.5-2 cm "bites" from the fascial edge and a 1cm "walk" between stitches. Skin will be closed with staples or monofilament suture according to surgeon preference. Drains will be placed on the mesh in each case, and one or two drains will be placed in the subcutaneous tissues at the discretion of the surgeon depending on the amount of subcutaneous tissue dissected.

Device: Bio-A Arm

Strattice Arm

ACTIVE COMPARATOR

Patients will receive underlay mesh tissue reinforcement followed by standard fascial closure with #1 PDS. As described by Dr. Stoppa10-12, the mesh will be secured via abdominal wall sutures. Additional full thickness sutures will be placed every 8 cm circumferentially. After securing the mesh in place, #1 PDS sutures will be used to close the fascia in a running fashion with 1.5-2 cm "bites" from the fascial edge and a 1cm "walk" between stitches. Skin will be closed with staples or monofilament suture according to surgeon preference. Drains will be placed on the mesh in each case, and one or two drains will be placed in the subcutaneous tissues at the discretion of the surgeon depending on the amount of subcutaneous tissue dissected..

Device: Strattice Arm

Interventions

Strattice Arm DEVICE

Biologic mesh to be placed during hernia repair surgery

Strattice Arm

Bio-A Arm DEVICE

Bioabsorbable mesh to be placed during hernia repair surgery

Bio-A Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 or older
• Grade II or III ventral hernia according to Ventral Hernia Working Group (VHWG)
• Pre-operative informed consent is obtainable

You may not qualify if:

• Return to the operating room within the next 1 year for additional open abdominal surgery is anticipated
• Absence of fascial defect or fascial defect less than 3 cm in greatest dimension
• Presence of previously place mesh (synthetic or biologic) at the site of surgery, which will not be completely removed and will, in part or whole, remain at the site of implantation of the study mesh
• Concurrent placement of another mesh (synthetic or biologic) at the site where the study mesh is placed
• Grade IV ventral hernia according to VHWG system
• ASA score IV or above
• Any disease or condition along with the surgeon's clinical judgment that contraindicates the use of either study mesh
• Pregnancy

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Atrium Health - Carolinas Medical Center

Charlotte, North Carolina, 28204, United States

Location

MeSH Terms

Conditions

Hernia, Ventral

Condition Hierarchy (Ancestors)

Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Research Director
• Organization: Carolinas HelathCare System

Amy.Lincourt@carolinashealthcare.org

704-355-3168

Study Officials

• Brant T Heniford, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 15, 2013
• First Posted: February 18, 2013
• Study Start: November 1, 2012
• Primary Completion: July 1, 2017
• Study Completion: July 21, 2017
• Last Updated: August 15, 2022
• Results First Posted: August 3, 2022

Record last verified: 2022-04

Locations

US (1)