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PeritonitisPRISTINENCT05684198

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

A study testing subcutaneous NPWT in people with Peritonitis and Surgical Site Infection, run by Medical University of Gdansk at 1 site in Poland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Peritonitis, Surgical Site Infection, Infections
What is being tested?
subcutaneous NPWT
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 sitePoland
Study dates
11 Jan 2023to 1 Nov 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • qualified for open abdomen treatment

Trial locations and contacts

1 site in 1 country.

Poland1 site

  • UCC Division of Oncological, Transplant and General Surgery

    Gdansk, Pomeranian Voivodeship, 80952

Other trials in Poland

About this study

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

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.

Read the 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.

Being tested
subcutaneous NPWT
Keywords
laparotomy, NPWT, primary closure, vacuum-assisted closure, VAC
Medical subject headings
Peritonitis, Surgical Wound Infection, Infections, Wound Infection

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • subcutaneous NPWTDevice

    Also called vacuum-assisted wound closure, Vivano, Renasys

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

Study groups in NCT05684198
Study groupRoleWhat they receive
subcutaneous NPWTExperimentalThe 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.
Receives: Device: subcutaneous NPWT
primary closureNo interventionThe 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    definitive wound closure, not followed by secondary wound dehiscence

    Measured: 30 days

  2. Time to end of surgical treatment of the wound

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

    Measured: 1 year

Secondary outcomes (9)

  1. Length of stay

    postoperative length of hospital stay

    Measured: 90 days

  2. Time to heal

    time to full epithelialisation of the wound

    Measured: 120 days

  3. Volume of wound drainage

    Volume of wound drainage collected in a NPWT or drainage collector

    Measured: 60 days

  4. Time of secondary NPWT treatment

    Duration of NPWT therapy administered if SSI occured

    Measured: 60 days

  5. 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)

    Measured: 60 days

  6. 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.

    Measured: 30 days

  7. 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)

    Measured: 7 days

  8. 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).

    Measured: 1 year

  9. Cost

    Cost of hospitalisation and outpatient visits

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jan 2023
  2. Study start11 Jan 2023
  3. Primary completion1 Nov 2025
  4. Study completion1 Nov 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05684198
Sponsor's protocol ID
420/1
Acronym
PRISTINE
Status last verified
May 2023
First submitted
29 Nov 2022
Last updated
3 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing subcutaneous NPWT in people with Peritonitis and Surgical Site Infection, run by Medical University of Gdansk at 1 site in Poland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Effective wound closure by 30th day post-op (time frame: 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05684198.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2025.

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