← Back to Search

Bioabsorbable Mesh

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

Charlotte, NC
N/A
Waitlist Available
Led By Brant T Heniford, MD
Research Sponsored by Atrium Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights
No Placebo-Only Group

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.

See full description
Eligible Conditions
  • Ventral Hernia

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Hernia Recurrence

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Bio-A ArmExperimental Treatment1 Intervention
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.
Group II: Strattice ArmActive Control1 Intervention
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..

Find a Location

Closest Location:Atrium Health - Carolinas Medical Center· Charlotte, NC· 959 miles

Who is running the clinical trial?

Atrium HealthLead Sponsor
121 Previous Clinical Trials
34,894 Total Patients Enrolled
Wake Forest University Health SciencesLead Sponsor
1,426 Previous Clinical Trials
2,502,635 Total Patients Enrolled
Brant T Heniford, MDPrincipal InvestigatorWake Forest University Health Sciences
2 Previous Clinical Trials
212 Total Patients Enrolled
Todd Heniford, MDPrincipal InvestigatorCarolinas Medical Center
5 Previous Clinical Trials
1,080 Total Patients Enrolled
~2 spots leftby Mar 2026