Comparing post-operative dressings for abdominal wall reconstruction
The Effects of Post-Operative Interventions on Surgical Site Occurrences in Abdominal Wall Reconstructions: A Randomized Controlled Trial
This study is trying to see which type of dressing after abdominal wall surgery—vacuum therapy, self-adhering mesh, or regular dressings—works best to prevent complications like infections for patients having hernia repairs.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Ohio State University Academic / other |
| Locations | 1 site (Columbus, Ohio) |
| Trial ID | NCT04906408 on ClinicalTrials.gov |
What this trial studies
This randomized controlled trial investigates the impact of different post-operative interventions on surgical site occurrences (SSOs) in patients undergoing abdominal wall reconstruction. The study compares the effectiveness of Prevena, a vacuum-assisted therapy, Prineo, a self-adhering mesh, and traditional incisional dressings in reducing complications such as infection and seroma. By focusing on patients with complex surgical needs, the trial aims to identify which dressing method best minimizes SSOs, thereby improving patient outcomes and reducing healthcare costs. The study includes patients over 18 years old who are good surgical candidates for elective ventral hernia repair.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old presenting for elective ventral hernia repair without active life-threatening conditions.
Not a fit: Patients with known allergies to the materials used in the dressings or those requiring emergent hernia repair may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly reduce the rates of surgical site complications in abdominal wall reconstruction patients.
How similar studies have performed: Previous studies have shown varying success with different post-operative interventions, but this specific comparison of dressings in abdominal wall reconstruction is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age \> 18 * Patients presenting for elective ventral hernia repair * Patients deemed to be good surgical candidates, with no active life-threatening cardiac disease, pulmonary disease, renal disease, hematologic disease -Patients who will have a closed incision following the surgery Exclusion Criteria: * Known allergy to any material used in any wound treatment (Prevena- Acrylic adhesive or silver, Prineo- Dermabond glue, Standard- Bacitracin, Xeroform, surgical tape) -Active smokers (within the past 4 weeks) presenting for elective hernia repair * Patients with active life-threatening cardiac disease, pulmonary disease, renal disease, hematologic disease presenting for elective ventral hernia repair * Patients presenting for emergent ventral hernia repair (in the setting of bowel strangulation, necrosis, penetrating trauma) as it will be difficult to consent those patients for the study preoperatively * Patients with severe systemic sepsis * Patients with frank purulence in the wound -Patients with an open wound following surgery -Patients undergoing a panniculectomy
Where this trial is running
Columbus, Ohio
- Department of Plastic Surgery — Columbus, Ohio, United States (Recruiting)
Study contacts
- Principal investigator: Jeffrey E Janis, MD — Ohio State University
- Study coordinator: Jeffrey Janis, MD
- Email: Jeffrey.Janis@osumc.edu
- Phone: 6143661242
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.