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)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 1 (1 locations)

1

Inselspital, Bern University Hospital

Bern, Switzerland, 3010