Status:
RECRUITING
The Effects of Post-Operative Interventions on Surgical Site Occurrences in AWR
Lead Sponsor:
Ohio State University
Conditions:
Abdomen Hernia
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Randomized controlled trial to compare SSO's in abdominal wall reconstruction patients using Prevena, Prineo, and traditional incisional dressings.
Detailed Description
Surgical site occurrences (SSOs) are a common complication of complex abdominal wall reconstruction (AWR), with rates ranging from 29-63.6%. Contributors to the high rates include: 1) comorbidities in...
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
Key Trial Info
Start Date :
September 17 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2028
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT04906408
Start Date
September 17 2021
End Date
May 1 2028
Last Update
March 27 2025
Active Locations (1)
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1
Department of Plastic Surgery
Columbus, Ohio, United States, 43212