Infections, Peritonitis, Surgical Site Infection, Wound Infection
Conditions
Keywords
laparotomy, NPWT, primary closure, vacuum-assisted closure, VAC
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.
Interventions
DEVICEsubcutaneous NPWT
Following fascia closure, NPWT system will be inserted into subcutaneous tissue, continuous negative pressure of 120 mmHg will be applied.
Sponsors
Medical University of Gdansk
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* qualified for an emergency laparotomy for peritonitis * gave written informed consent
Exclusion criteria
* qualified for open abdomen treatment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effective wound closure by 30th day post-op | 30 days | definitive wound closure, not followed by secondary wound dehiscence |
| Time to end of surgical treatment of the wound | 1 year | Time of last out-patient visit ending the process of treating surgical wound |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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) |
| 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). |
| Cost | 1 year | Cost of hospitalisation and outpatient visits |
| Length of stay | 90 days | postoperative length of hospital stay |
| Time to heal | 120 days | time to full epithelialisation of the wound |
| Volume of wound drainage | 60 days | Volume of wound drainage collected in a NPWT or drainage collector |
| Time of secondary NPWT treatment | 60 days | Duration of NPWT therapy administered if SSI occured |
| 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) |
Countries
Poland
Outcome results
None listed