NPWT vs Primary Closure in SSI Prevention for Emergency Laparotomies for Peritonitis (PRISTINE)

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.

Study Overview

• Status: Recruiting
• Conditions: Infections; Surgical Site Infection; Wound Infection; Peritonitis
• Intervention / Treatment: Device: subcutaneous NPWT

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.

• Study Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Katarzyna M Polomska; Phone Number: +48794037928; Email: k.polomska@gumed.edu.pl
• Study Contact Backup: Name: Piotr Spychalski; Phone Number: +48667843555; Email: piotr.spychalski@gumed.edu.pl

Study Locations

• Poland
  • Pomerania
    • Gdańsk, Pomerania, Poland, 80952
      • Recruiting
      • UCC Division of Oncological, Transplant and General Surgery
      • Contact: Katarzyna M Polomska; Phone Number: +48794037928; Email: k.polomska@gumed.edu.pl
      • Contact: Piotr Spychalski, PhD, MD; Phone Number: +48667843555; Email: piotr.spychalski@gumed.edu.pl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

• qualified for open abdomen treatment

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: subcutaneous NPWT; 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; Following fascia closure, NPWT system will be inserted into subcutaneous tissue, continuous negative pressure of 120 mmHg will be applied.; Other Names: vacuum-assisted wound closure; Vivano; Renasys
No Intervention: primary closure; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effective wound closure by 30th day post-op	definitive wound closure, not followed by secondary wound dehiscence	30 days
Time to end of surgical treatment of the wound	Time of last out-patient visit ending the process of treating surgical wound	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of stay	postoperative length of hospital stay	90 days
Time to heal	time to full epithelialisation of the wound	120 days
Volume of wound drainage	Volume of wound drainage collected in a NPWT or drainage collector	60 days
Time of secondary NPWT treatment	Duration of NPWT therapy administered if SSI occured	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)	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:Pain or tendernessLocalized swellingRednessHeat; 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.	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)	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).	1 year
Cost	Cost of hospitalisation and outpatient visits	1 year

Collaborators and Investigators

• Sponsor: Medical University of Gdansk
• Investigators: Principal Investigator: Jaroslaw Kobiela, Prof., MUG Division of General Surgery; Principal Investigator: Piotr Spychalski, MD PhD, MUG Division of General Surgery; Principal Investigator: Katarzyna M Polomska, Medical University of Gdansk (MUG)

Study record dates

Study Major Dates

• Study Start (Actual): January 11, 2023
• Primary Completion (Anticipated): November 1, 2024
• Study Completion (Anticipated): September 1, 2025

Study Registration Dates

• First Submitted: November 29, 2022
• First Submitted That Met QC Criteria: January 11, 2023
• First Posted (Actual): January 13, 2023

Study Record Updates

• Last Update Posted (Actual): May 19, 2023
• Last Update Submitted That Met QC Criteria: May 18, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: laparotomy; NPWT; VAC; primary closure; vacuum-assisted closure
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Peritoneal Diseases; Postoperative Complications; Disease Attributes; Intraabdominal Infections; Emergencies; Infections; Communicable Diseases; Surgical Wound Infection; Peritonitis; Wound Infection
• Other Study ID Numbers: 420/1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No