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

Closed Incision Negative Pressure Wound Therapy for the Prevention of Surgical Site Infections in Abdominal Surgery - A Multicenter Randomized Controlled 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.

Study Overview

• Status: Not yet recruiting
• Conditions: Surgical Wound Infection
• Intervention / Treatment: Device: Closed incision negative pressure wound therapy; Device: Standard dressing

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 increased healthcare costs. Closed incision negative pressure wound therapy (ciNPWT) is a non-invasive, vacuum-assisted system that applies negative pressure to closed surgical incisions. Recent meta-analyses suggest that ciNPWT reduces the risk of SSI in abdominal surgery. However, based on the available randomized controlled trials (RCT), the evidence for the effect of ciNPWT on SSI in abdominal surgery is insufficient.

Rationale:

Considering the frequent occurrence of SSI in abdominal surgery, associated worse outcomes, and insufficient evidence, an adequately powered, robust RCT investigating the effect of ciNPWT on SSI in elective and emergency abdominal surgery is warranted. Provided that ciNPWT significantly reduces the incidence of SSI, this adjunct to surgical therapy has the potential to fundamentally improve patient outcomes in abdominal surgery.

Aim of the trial:

To investigate the effect of ciNPWT on superficial and deep SSI in patients undergoing elective or emergency abdominal surgery by laparotomy.

Methodology:

Multicenter, open-label, two arm, parallel group RCT. Patients undergoing elective or emergency laparotomy will be enrolled. During surgery, participants will be randomized in a 1:1 ratio to the ciNPWT (treatment) or standard dressing (control) group. After the completion of abdominal surgery and standardized skin closure with staples, either ciNPWT or standard dry dressings will be applied. Other than the study procedure, participants in both groups will be treated the same according to the current standard of care at the participating centers. Data collection will be carried out during the subsequent hospital stay and at 30 (+/- 7) days postoperatively.

Hypothesis:

The investigators hypothesize that ciNPWT will significantly reduce the incidence of superficial and deep SSI in patients undergoing laparotomy.

• Study Type: Interventional
• Enrollment (Estimated): 654
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tobias Haltmeier, MD; Phone Number: +41 31 664 03 04; Email: tobias.haltmeier@insel.ch

Study Locations

• Switzerland
  • Bern, Switzerland, 3010
    • Inselspital, Bern University Hospital
    • Contact: Tobias Haltmeier, MD; Phone Number: +41 31 664 03 04; Email: tobias.haltmeier@insel.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Closed incision negative pressure wound therapy; At the completion of the surgical procedure, the skin will be closed with staples at a distance of two centimeters from each other. After skin closure, ciNPWT will be applied, using a commercially available device. The device will be left in place for 7 days.	Device: Closed incision negative pressure wound therapy; After the completion of abdominal surgery and standardised skin closure with staples, ciNPWT will be applied, using a commercially available device.
Active Comparator: Standard dressing; At the completion of the surgical procedure, the skin will be closed with staples at a distance of two centimeters from each other. After skin closure, conventional dry dressings will be applied. Conventional dressings will be changed according to clinical practice in the participating study centers.	Device: Standard dressing; After the completion of abdominal surgery and standardised skin closure with staples, standard dressings will be applied.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Composite incidence of superficial and deep surgical site infections	Number of participants with a superficial or deep surgical site infections at 30 (+/- 7) days postoperatively.	30 (+/- 7) days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
30-day mortality		30 days
Overall surgical site infections (superficial, deep, and organ space)	Number of participants with a superficial or deep or organ space surgical site infections at 30 (+/- 7) days postoperatively.	30 (+/- 7) days
Superficial, deep, and organ space surgical site infections as separate outcomes	Number of participants with a superficial surgical site infections at 30 (+/- 7) days postoperatively. Number of participants with a deep surgical site infections at 30 (+/- 7) days postoperatively. Number of participants with an organ space surgical site infections at 30 (+/- 7) days postoperatively.	30 (+/- 7) days
Other wound complications (wound dehiscence, seroma, hematoma)	Number of participants with another wound complication at 30 (+/- 7) days postoperatively.	30 (+/- 7) days
Postoperative hospital length of stay		Usually between 1 and 14 days
Duration of closed incision negative pressure wound therapy		7 days
Number of outpatient visits		30 days
Postoperative health-related quality of life (SF-36 Health Survey)	Range from 0 (worst) to 100 (best).	30 (+/- 7) days
Costs for inpatient treatment		Usually between 1 and 14 days
In-hospital mortality		Usually between 1 and 14 days

Collaborators and Investigators

• Sponsor: Insel Gruppe AG, University Hospital Bern
• Collaborators: Clinical Trials Unit University of Bern
• Investigators: Principal Investigator: Tobias Haltmeier, MD, Inselspital, Bern University Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2024
• Primary Completion (Estimated): October 31, 2027
• Study Completion (Estimated): May 31, 2028

Study Registration Dates

• First Submitted: September 27, 2023
• First Submitted That Met QC Criteria: September 28, 2023
• First Posted (Actual): October 5, 2023

Study Record Updates

• Last Update Posted (Actual): October 10, 2023
• Last Update Submitted That Met QC Criteria: October 6, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Disease Attributes; Infections; Communicable Diseases; Wounds and Injuries; Surgical Wound; Surgical Wound Infection; Wound Infection
• Other Study ID Numbers: CISSI

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No