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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06068517
Other study ID # CISSI
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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