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

Surgical Wound Infection Clinical Trial

— CISSI  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06068517
• Other study ID #: CISSI
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 1, 2024
• Est. completion date: May 31, 2028

Study information

• Verified date: October 2023
• Source: Insel Gruppe AG, University Hospital Bern
• Contact: Tobias Haltmeier, MD
• Phone: 31 664 03 04
• Email: tobias.haltmeier[@]insel.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 654
• Est. completion date: May 31, 2028
• Est. primary completion date: October 31, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Infections
• Surgical Wound
• Surgical Wound Infection
• Wound Infection
• Wounds and Injuries

Intervention

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.
• Standard dressing
After the completion of abdominal surgery and standardised skin closure with staples, standard dressings will be applied.

Locations

Country	Name	City	State
Switzerland	Inselspital, Bern University Hospital	Bern

Sponsors (2)

Lead Sponsor	Collaborator
Insel Gruppe AG, University Hospital Bern	Clinical Trials Unit University of Bern

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Other wound complications (wound dehiscence, seroma, hematoma)	Number of participants with another wound complication at 30 (+/- 7) days postoperatively.	30 (+/- 7) days
Secondary	Postoperative hospital length of stay		Usually between 1 and 14 days
Secondary	Duration of closed incision negative pressure wound therapy		7 days
Secondary	Number of outpatient visits		30 days
Secondary	Postoperative health-related quality of life (SF-36 Health Survey)	Range from 0 (worst) to 100 (best).	30 (+/- 7) days
Secondary	Costs for inpatient treatment		Usually between 1 and 14 days
Secondary	In-hospital mortality		Usually between 1 and 14 days
Secondary	30-day mortality		30 days