Status:
NOT_YET_RECRUITING
Closed Incision Negative Pressure Wound Therapy for the Prevention of Surgical Site Infections in Abdominal Surgery
Lead Sponsor:
Insel Gruppe AG, University Hospital Bern
Collaborating Sponsors:
Clinical Trials Unit University of Bern
Conditions:
Surgical Wound Infection
Eligibility:
All Genders
19+ years
Phase:
NA
Brief Summary
Surgical site infections (SSI) are a frequent complication in abdominal surgery. SSI lead to worse outcomes for the affected patients and significantly higher healthcare costs. Closed incision negativ...
Detailed Description
Background: Surgical site infections (SSI) are a frequent complication after abdominal surgery and are associated with increased morbidity and mortality, longer hospital stay, and significantly incre...
Eligibility Criteria
Inclusion
- Elective or emergency laparotomy, or laparoscopy converted to laparotomy, including surgery for complications after elective operations
- Incision length ≥ 10 cm
- Centers for Disease Control and Prevention (CDC) wound class 1 and 2 (clean, clean-contaminated)
- Abdominal closure with or without mesh implantation
- Primary abdominal closure or closure after open abdomen treatment
- Age over 18 years
- Written informed consent
Exclusion
- Age ≤ 18 years
- CDC wound class 4 (dirty/infected wound)
- Organ transplantation
- Sensitivity or allergy to silver
Key Trial Info
Start Date :
March 1 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 31 2028
Estimated Enrollment :
654 Patients enrolled
Trial Details
Trial ID
NCT06068517
Start Date
March 1 2026
End Date
May 31 2028
Last Update
December 5 2024
Active Locations (1)
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1
Inselspital, Bern University Hospital
Bern, Switzerland, 3010