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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age19+
SponsorInsel Gruppe AG, University Hospital Bern

About this trial

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 negative pressure wound therapy (ciNPWT) consists of a non-invasive, vacuum-assisted system that applies negative pressure to closed surgical incisions. It is currently unclear, if ciNPWT reduces SSI in patients undergoing abdominal surgery. This trial will investigate the effect of ciNPWT on SSI in abdominal surgery.

Eligibility criteria

Qualifiers

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

Disqualifiers

Age ≤ 18 years

CDC wound class 4 (dirty/infected wound)

Organ transplantation

Sensitivity or allergy to silver

Trial design

Treatments tested in this trial

  • Closed incision negative pressure wound therapy
  • Standard dressing

Treatment groups

654 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Insel Gruppe AG, University Hospital Bern

Lead sponsor

Clinical Trials Unit University of Bern

Collaborator