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NCT Number: NCT05684198

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UCC Division of Oncological, Transplant and General Surgery

Gdansk, Pomeranian Voivodeship, 80952, Poland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • qualified for open abdomen treatment

Treatment and study plan

subcutaneous NPWT

Device

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

Other names: vacuum-assisted wound closure, Vivano, Renasys

Primary outcomes

  1. Effective wound closure by 30th day post-op

    Time frame: 30 days

    definitive wound closure, not followed by secondary wound dehiscence

  2. Time to end of surgical treatment of the wound

    Time frame: 1 year

    Time of last out-patient visit ending the process of treating surgical wound

Secondary outcomes

  1. Length of stay

    Time frame: 90 days

    postoperative length of hospital stay

  2. Time to heal

    Time frame: 120 days

    time to full epithelialisation of the wound

  3. Volume of wound drainage

    Time frame: 60 days

    Volume of wound drainage collected in a NPWT or drainage collector

  4. Time of secondary NPWT treatment

    Time frame: 60 days

    Duration of NPWT therapy administered if SSI occured

  5. Post-operative morbidity

    Time frame: 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)

  6. SSI presence or absence

    Time frame: 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:
    • 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.

  7. Pain level

    Time frame: 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)

  8. Scar quality

    Time frame: 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).

  9. Cost

    Time frame: 1 year

    Cost of hospitalisation and outpatient visits

Sponsors and collaborators

Lead sponsor

Medical University of Gdansk

Other

Registry information

Official study title

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

Acronym: PRISTINE

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jan 13, 2023
Registry last updated
Dec 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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