Study Comparing Wound Dressings After Hernia Surgery

This study is looking at how different wound dressings affect healing after surgery for an abdominal hernia (a bulge in the abdomen). Researchers want to see if using Prevena (a vacuum-assisted dressing), Prineo (another type of dressing), or a traditional dressing like bacitracin/xeroform can lower the chances of problems after surgery. These problems, called surgical site occurrences (SSOs), include infections, seromas (fluid collections), and hematomas (blood collections). You might be able to join if you are over 18, having elective ventral hernia repair, and are a good candidate for surgery. The study aims to enroll 300 participants.

Study design
This is a randomized controlled trial comparing three different wound dressings. It plans to enroll 300 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for rates of infection, seroma, and hematoma at 6 weeks after surgery.

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NCT04906408

The Effects of Post-Operative Interventions on Surgical Site Occurrences in AWR

Recruiting
NAAges 18+InterventionalPrevention
Ohio State University
~300 participants
Updated 2025-03-27 on ClinicalTrials.gov
What's tested:PrevenaPrineoTraditional

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Rate of Infection
Measured over At 6 weeks postoperatively
+8 more outcomes measured
Abdomen Hernia
1 sites across 1 states
Ohio1
  • Jeffrey E Janis, MD · PRINCIPAL_INVESTIGATOR · Ohio State University

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Eligibility criteria

Inclusion

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

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
  • Rate of InfectionAt 6 weeks postoperatively
  • Rate of SeromaAt 6 weeks postoperatively
  • Rate of HematomaAt 6 weeks postoperatively
  • Rate of DehiscenceAt 6 weeks postoperatively
  • Rate of Skin necrosisAt 6 weeks postoperatively
  • Rate of Enterocutaneous fistulaAt 6 weeks postoperatively
  • Rate of Mesh infectionAt 6 weeks postoperatively
  • Rate of Hernia recurrenceAt 6 weeks postoperatively
  • Rate of BulgeAt 6 weeks postoperatively