NPWT vs Primary Closure in SSI Prevention for Emergency Laparotomies for Peritonitis

Not Applicable

Recruiting

• Conditions: Peritonitis; Infections; Wound Infection; Surgical Site Infection
• Interventions: Device: subcutaneous NPWT

• Registration Number: NCT05684198
• Lead Sponsor: Medical University of Gdansk

Brief Summary

The study aims to evaluate the efficacy of negative pressure wound therapy (NPWT) compared with primary closure (PC) in surgical site infection (SSI) prevention for laparotomy for peritonitis.

Detailed Description

Surgical site infection is a particularly common morbidity in contaminated surgeries leading to prolonged length of hospital stay, healing time, and a significant financial burden on healthcare systems.

Hence, the objective of PRISTINE trial is to compare the effectiveness of subcutaneous NPWT with PC for SSI prevention in patients who, due to wound contamination, are prone to infection. Moreover, with a further cost analysis, the investigators aim to evaluate the rationale for the implementation of routine preventive NPWT for laparotomy for diffuse peritonitis.

Patients qualified for an emergency laparotomy for peritonitis in University Clinical Centre (UCC) Division of Oncological, Endocrine and General Surgery will be identified. Prior to laparotomy, participants will be randomized in 1:1 ratio to subcutaneous NPWT or PC. The assigned intervention will be performed intraoperatively, after fascia closure.

All participants will receive an empirical antibiotic therapy regimen consisting of tazobactam/piperacillin or ciprofloxacin+ metronidazole. Participants will be followed-up postoperatively for one year.

In case of an SSI all participants, regardless of their initial allocation, will be treated according to the standard of care with prolonged NPWT and targeted antibiotic therapy.

Study Timeline

• Study First Submitted: 2022-11-29
• Study Start: 2023-01-11
• Study First Submitted QC: 2023-01-11
• Study First Posted: 2023-01-13
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-18
• Last Update Posted: 2023-05-19
• Primary Completion: 2024-11
• Study Completion: 2025-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• qualified for an emergency laparotomy for peritonitis
• gave written informed consent

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Exclusion Criteria

• qualified for open abdomen treatment

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
subcutaneous NPWT	subcutaneous NPWT	The peritoneum and fascia will be closed as in the PC arm. Subsequently, patients will be treated with commercially available vacuum-assisted closure systems (provided by Smith\&Nephew or Hartmann) according to the manufacturer's instructions. Following fascia closure, the NPWT foam will be adjusted to the wound size to fill the wound cavity without causing excessive wound dehiscence. Subsequently, the foam will be placed in the subcutaneous tissue. The foam will not be fixated on the skin with sutures. The wound will be sealed with adhesive film. In case of air leak in problematic areas such as the navel or ostomy, ostomy paste will be used to create a tighter seal. Continuous pressure of 120 mmHg will be applied. On the 3rd day postop, the dressing will be removed and closure by secondary intention will be performed.

Primary Outcome Measures

Name	Time	Method
Time to end of surgical treatment of the wound	1 year	Time of last out-patient visit ending the process of treating surgical wound
Effective wound closure by 30th day post-op	30 days	definitive wound closure, not followed by secondary wound dehiscence

Secondary Outcome Measures

Name	Time	Method
Time of secondary NPWT treatment	60 days	Duration of NPWT therapy administered if SSI occured
SSI presence or absence	30 days	Surgical Site Infection according to Centre for Disease Control (CDC) criteria: Infection occurring within the first 30 post-operative days with at least one of the following: * Purulent drainage from the incision; * Organisms isolated from an aseptically obtained culture of fluid or tissue from the incision; * Incision is deliberately opened by a surgeon AND at least one of the following signs/symptoms of infection: 1. Pain or tenderness; 2. Localized swelling; 3. Redness; 4. Heat; * Diagnosis of SSI by the surgeon or attending physician; Due to the inability to implement CDC for wounds treated with NPWT, the investigators have included additional SSI criteria: the absolute necessity to prolong NPWT after 3rd day postop, an anergic wound morphology or slough.
Length of stay	90 days	postoperative length of hospital stay
Time to heal	120 days	time to full epithelialisation of the wound
Scar quality	1 year	Measured with Vancouver Scar Scale (VSS). This scale ranges from 0 (representing normal skin) to 13 (representing worst scar imaginable). VSS provides the assessment of the following wound characteristics: pigmentation (0-2), vascularity (0-3), pliability (0-5), height (0-3).
Volume of wound drainage	60 days	Volume of wound drainage collected in a NPWT or drainage collector
Post-operative morbidity	60 days	occurrence of adverse events and complications following surgery measured with Clavien-Dindo scale (grade I to V; grade I represents any deviation from the normal post-operative course not requiring surgical, endoscopic or radiological intervention and grade 5 represents patient's death)
Pain level	7 days	Pain measured with Visual Analogue Scale every 8h (subjective pain strength scale from 0 to 10; 0 represents no pain and 10 represents the worst pain)
Cost	1 year	Cost of hospitalisation and outpatient visits

Trial Locations

Locations (1)

UCC Division of Oncological, Transplant and General Surgery; 🇵🇱 Gdańsk, Pomerania, Poland