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Synthetic versus Biologic Mesh for Complex Open Ventral Hernia Repair: A Pilot Randomized Controlled Trial
Oscar A Olavarria1,2, Karla Bernardi1,2, Naila H Dhanani1,2
1Department of Surgery, McGovern Medical School at the University of Texas Health Science Center at Houston, Houston, Texas, USA.
Surgical Infections
|December 1, 2020
Summary
Biologic mesh did not show benefits over synthetic mesh for complex ventral hernia repair one year after surgery. Bayesian analysis indicates biologic mesh may increase the risk of major complications compared to synthetic options.
Area of Science:
- Surgical Innovation
- Biomaterials Science
- Clinical Trials
Background:
- Biologic mesh is often used for complex ventral hernia repair (VHR) in challenging cases.
- No randomized controlled trials (RCTs) have directly compared biologic and synthetic mesh for VHR.
- This study aimed to compare outcomes between biologic and synthetic mesh in complex VHR.
Purpose of the Study:
- To test the hypothesis that biologic mesh leads to fewer major complications at one year post-operative compared to synthetic mesh.
- To evaluate secondary outcomes including surgical site infections, seromas, hematomas, wound dehiscence, re-admissions, and complication grades.
Main Methods:
- A single-center, pilot randomized controlled trial (RCT) was conducted.
- Eligible patients undergoing complex, open VHR were randomized to receive either biologic or synthetic mesh.
- The primary outcome was a composite of mesh infection, recurrence, or re-operation at one year; secondary outcomes were also assessed.
Main Results:
- Biologic mesh group had a higher percentage of major complications (42.4% vs. 21.6%), surgical site infections (15.9% vs. 9.3%), wound dehiscence (25.0% vs. 14.0%), and re-admissions (22.7% vs. 9.3%) compared to synthetic mesh.
- Bayesian analysis showed a 95% probability of increased risk for major complications with biologic mesh.
- No significant differences were found for seromas, hematomas, or Clavien-Dindo complication grade.
Conclusions:
- In elective complex open VHR, biologic mesh offers no apparent benefit over synthetic mesh regarding one-year outcomes.
- Biologic mesh may be associated with an increased probability of major complications.
- Further research is warranted to clarify the role of different mesh types in complex VHR.
