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

Surgical Site Infection Clinical Trial

— PRISTINE  

Official title:

Emergency Laparotomy for Peritonitis and Surgical Site Infection: Preventive Subcutaneous NPWT vs Primary Closure - a Randomized Health Services Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05684198
• Other study ID #: 420/1
• Status: Recruiting
• Phase: N/A
• Start date: January 11, 2023
• Est. completion date: September 2025

Study information

• Verified date: May 2023
• Source: Medical University of Gdansk
• Contact: Katarzyna M Polomska
• Phone: +48794037928
• Email: k.polomska[@]gumed.edu.pl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: September 2025
• Est. primary completion date: November 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• qualified for an emergency laparotomy for peritonitis

• gave written informed consent

Exclusion Criteria:

• qualified for open abdomen treatment

Related Conditions & MeSH terms

• Communicable Diseases
• Emergencies
• Infections
• Peritonitis
• Surgical Site Infection
• Surgical Wound Infection
• Wound Infection

Intervention

Device:
• subcutaneous NPWT
Following fascia closure, NPWT system will be inserted into subcutaneous tissue, continuous negative pressure of 120 mmHg will be applied.

Locations

Country	Name	City	State
Poland	UCC Division of Oncological, Transplant and General Surgery	Gdansk	Pomerania

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Gdansk

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effective wound closure by 30th day post-op	definitive wound closure, not followed by secondary wound dehiscence	30 days
Primary	Time to end of surgical treatment of the wound	Time of last out-patient visit ending the process of treating surgical wound	1 year
Secondary	Length of stay	postoperative length of hospital stay	90 days
Secondary	Time to heal	time to full epithelialisation of the wound	120 days
Secondary	Volume of wound drainage	Volume of wound drainage collected in a NPWT or drainage collector	60 days
Secondary	Time of secondary NPWT treatment	Duration of NPWT therapy administered if SSI occured	60 days
Secondary	Post-operative morbidity	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)	60 days
Secondary	SSI presence or absence	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: Pain or tenderness; Localized swelling; Redness; 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.	30 days
Secondary	Pain level	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)	7 days
Secondary	Scar quality	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).	1 year
Secondary	Cost	Cost of hospitalisation and outpatient visits	1 year