Closed Incision Negative Pressure Wound Therapy for the Prevention of Surgical Site Infections in Abdominal Surgery

Launched by INSEL GRUPPE AG, UNIVERSITY HOSPITAL BERN · Sep 28, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at a new way to help prevent surgical site infections (SSIs) after abdominal surgery using a method called closed incision negative pressure wound therapy (ciNPWT). SSIs are common complications that can make recovery harder and cost more for patients. ciNPWT uses a gentle vacuum to help keep the surgical incision clean and promote healing. The main goal of this study is to find out if using this therapy can reduce the risk of infections for patients who have had surgery on their abdomen.

To participate in this trial, individuals must be adults over 18 years old who are undergoing certain types of abdominal surgeries, such as elective or emergency laparotomies (a type of surgery where the abdomen is opened). The surgical incision must be at least 10 centimeters long and classified as clean or clean-contaminated. Patients with dirty or infected wounds, those under 18, or individuals with allergies to silver will not be eligible. Participants in the trial will undergo standard surgical procedures and, if selected, may receive the ciNPWT treatment to see how it affects their recovery. The trial is not yet recruiting, so there will be more information available as it begins.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • Age ≤ 18 years
• • CDC wound class 4 (dirty/infected wound)
• • Organ transplantation
• • Sensitivity or allergy to silver