Clinical trial NCT05684198: NPWT vs Primary Closure in SSI Prevention for Emergency Laparotomies for Peritonitis
Official title: Emergency Laparotomy for Peritonitis and Surgical Site Infection: Preventive Subcutaneous NPWT vs Primary Closure - a Randomized Health Services Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Peritonitis
Surgical Site Infection
Infections
Wound Infection
Keywords: laparotomy
NPWT
primary closure
vacuum-assisted closure
VAC
Lead sponsor: Medical University of Gdansk
Sponsor class: OTHER
First posted: 2023-01-13
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* qualified for open abdomen treatment

Primary outcomes:
measure: Effective wound closure by 30th day post-op
timeFrame: 30 days
measure: Time to end of surgical treatment of the wound
timeFrame: 1 year
Secondary outcomes:
measure: Length of stay
timeFrame: 90 days
measure: Time to heal
timeFrame: 120 days
measure: Volume of wound drainage
timeFrame: 60 days
measure: Time of secondary NPWT treatment
timeFrame: 60 days
measure: Post-operative morbidity
timeFrame: 60 days
measure: SSI presence or absence
timeFrame: 30 days
measure: Pain level
timeFrame: 7 days
measure: Scar quality
timeFrame: 1 year
measure: Cost
timeFrame: 1 year
Other outcomes:
Locations:
city: Gdańsk
country: Poland
facility: UCC Division of Oncological, Transplant and General Surgery
state: Pomerania
Study officials:
affiliation: MUG Division of General Surgery
name: Piotr Spychalski, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Medical University of Gdansk (MUG)
name: Katarzyna M Polomska
role: PRINCIPAL_INVESTIGATOR
affiliation: MUG Division of General Surgery
name: Jaroslaw Kobiela, Prof.
role: PRINCIPAL_INVESTIGATOR
References: