An interventional study of subcutaneous NPWT in Peritonitis, Surgical Site Infection and Infections, sponsored by Medical University of Gdansk. Completed at 1 site in Poland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-03.
Sponsored by Medical University of Gdansk · Not applicable, Interventional, and Health services research
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.
167 studies on the registry are indexed under Peritonitis; 23 are open to participants now.
This study's enrollment of 50 is below the median of 79 across 106 interventional studies indexed under Peritonitis.
Browse Peritonitis studies →Medical University of Gdansk is the lead sponsor of 133 studies on the registry; 46 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Device: subcutaneous NPWT
The peritoneum will be closed as a separate layer with a 2-0 multifilament absorbable suture. Subsequently, the fascia will be closed with a continuous suture using absorbable monofilament 0 sutures. Subcutaneous tissue will be rinsed twice with hypochlorite solution following peritoneal closure and fascial closure. Interrupted subcutaneous closure will be performed with absorbable multifilament 2-0 sutures. Following skin disinfection with an alcohol solution, the skin will be closed with non-absorbable monofilament 2-0 or 3-0 sutures using the interrupted mattress technique. Conventional Cosmopor® sterile gauze dressings will be applied. Unless the dressing material will be saturated, the dressing will remain unchanged until 3rd day post-op.
Following fascia closure, NPWT system will be inserted into subcutaneous tissue, continuous negative pressure of 120 mmHg will be applied.
Also known as: vacuum-assisted wound closure, Vivano, Renasys
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.
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
This study is completed, as verified in May 2023. You cannot join it, but the record below documents what was studied.
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