Closed Incision Negative Pressure Wound Therapy for the Prevention of Surgical Site Infections in Abdominal Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Closed incision negative pressure wound therapy, Standard dressing.
- Who it may be relevant to
- Registry conditions: Surgical Wound Infection. Basic parameters: from 19 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Switzerland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Closed Incision Negative Pressure Wound Therapy for the Prevention of Surgical Site Infections in Abdominal Surgery - A Multicenter Randomized Controlled Trial
Overview
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.
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.
Interventions
- 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. - Device Standard dressing
After the completion of abdominal surgery and standardised skin closure with staples, standard dressings will be applied.
Primary outcome measures
- Composite incidence of superficial and deep surgical site infections [Time frame: 30 (+/- 7) days]
Secondary outcome measures (10)
- Overall surgical site infections (superficial, deep, and organ space) [Time frame: 30 (+/- 7) days]
- Superficial, deep, and organ space surgical site infections as separate outcomes [Time frame: 30 (+/- 7) days]
- Other wound complications (wound dehiscence, seroma, hematoma) [Time frame: 30 (+/- 7) days]
- Postoperative hospital length of stay [Time frame: Usually between 1 and 14 days]
- Duration of closed incision negative pressure wound therapy [Time frame: 7 days]
- Number of outpatient visits [Time frame: 30 days]
- Postoperative health-related quality of life (SF-36 Health Survey) [Time frame: 30 (+/- 7) days]
- Costs for inpatient treatment [Time frame: Usually between 1 and 14 days]
- In-hospital mortality [Time frame: Usually between 1 and 14 days]
- 30-day mortality [Time frame: 30 days]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Switzerland · 1 center
- Inselspital, Bern University Hospital — Bern
Identifiers
NCT: NCT06068517 · CISSI