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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
50
Following fascia closure, NPWT system will be inserted into subcutaneous tissue, continuous negative pressure of 120 mmHg will be applied.
UCC Division of Oncological, Transplant and General Surgery
Gdansk, Pomeranian Voivodeship, Poland
Effective wound closure by 30th day post-op
definitive wound closure, not followed by secondary wound dehiscence
Time frame: 30 days
Time to end of surgical treatment of the wound
Time of last out-patient visit ending the process of treating surgical wound
Time frame: 1 year
Length of stay
postoperative length of hospital stay
Time frame: 90 days
Time to heal
time to full epithelialisation of the wound
Time frame: 120 days
Volume of wound drainage
Volume of wound drainage collected in a NPWT or drainage collector
Time frame: 60 days
Time of secondary NPWT treatment
Duration of NPWT therapy administered if SSI occured
Time frame: 60 days
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)
Time frame: 60 days
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: 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.
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Time frame: 30 days
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)
Time frame: 7 days
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).
Time frame: 1 year
Cost
Cost of hospitalisation and outpatient visits
Time frame: 1 year