search
Back to results

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

Primary Purpose

Peritonitis, Surgical Site Infection, Infections

Status
Recruiting
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
subcutaneous NPWT
Sponsored by
Medical University of Gdansk
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Peritonitis focused on measuring laparotomy, NPWT, primary closure, vacuum-assisted closure, VAC

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: qualified for an emergency laparotomy for peritonitis gave written informed consent Exclusion Criteria: qualified for open abdomen treatment

Sites / Locations

  • UCC Division of Oncological, Transplant and General SurgeryRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

subcutaneous NPWT

primary closure

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Length of stay
postoperative length of hospital stay
Time to heal
time to full epithelialisation of the wound
Volume of wound drainage
Volume of wound drainage collected in a NPWT or drainage collector
Time of secondary NPWT treatment
Duration of NPWT therapy administered if SSI occured
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)
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 tenderness Localized swelling Redness 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
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
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
Cost of hospitalisation and outpatient visits

Full Information

First Posted
November 29, 2022
Last Updated
May 18, 2023
Sponsor
Medical University of Gdansk
search

1. Study Identification

Unique Protocol Identification Number
NCT05684198
Brief Title
NPWT vs Primary Closure in SSI Prevention for Emergency Laparotomies for Peritonitis
Acronym
PRISTINE
Official Title
Emergency Laparotomy for Peritonitis and Surgical Site Infection: Preventive Subcutaneous NPWT vs Primary Closure - a Randomized Health Services Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 11, 2023 (Actual)
Primary Completion Date
November 2024 (Anticipated)
Study Completion Date
September 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical University of Gdansk

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peritonitis, Surgical Site Infection, Infections, Wound Infection
Keywords
laparotomy, NPWT, primary closure, vacuum-assisted closure, VAC

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
subcutaneous NPWT
Arm Type
Experimental
Arm Description
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.
Arm Title
primary closure
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
subcutaneous NPWT
Other Intervention Name(s)
vacuum-assisted wound closure, Vivano, Renasys
Intervention Description
Following fascia closure, NPWT system will be inserted into subcutaneous tissue, continuous negative pressure of 120 mmHg will be applied.
Primary Outcome Measure Information:
Title
Effective wound closure by 30th day post-op
Description
definitive wound closure, not followed by secondary wound dehiscence
Time Frame
30 days
Title
Time to end of surgical treatment of the wound
Description
Time of last out-patient visit ending the process of treating surgical wound
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Length of stay
Description
postoperative length of hospital stay
Time Frame
90 days
Title
Time to heal
Description
time to full epithelialisation of the wound
Time Frame
120 days
Title
Volume of wound drainage
Description
Volume of wound drainage collected in a NPWT or drainage collector
Time Frame
60 days
Title
Time of secondary NPWT treatment
Description
Duration of NPWT therapy administered if SSI occured
Time Frame
60 days
Title
Post-operative morbidity
Description
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
Title
SSI presence or absence
Description
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 tenderness Localized swelling Redness 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
Title
Pain level
Description
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
Title
Scar quality
Description
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
Title
Cost
Description
Cost of hospitalisation and outpatient visits
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: qualified for an emergency laparotomy for peritonitis gave written informed consent Exclusion Criteria: qualified for open abdomen treatment
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Katarzyna M Polomska
Phone
+48794037928
Email
k.polomska@gumed.edu.pl
First Name & Middle Initial & Last Name or Official Title & Degree
Piotr Spychalski
Phone
+48667843555
Email
piotr.spychalski@gumed.edu.pl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Piotr Spychalski, MD PhD
Organizational Affiliation
MUG Division of General Surgery
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Katarzyna M Polomska
Organizational Affiliation
Medical University of Gdansk (MUG)
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jaroslaw Kobiela, Prof.
Organizational Affiliation
MUG Division of General Surgery
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCC Division of Oncological, Transplant and General Surgery
City
Gdańsk
State/Province
Pomerania
ZIP/Postal Code
80952
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Katarzyna M Polomska
Phone
+48794037928
Email
k.polomska@gumed.edu.pl
First Name & Middle Initial & Last Name & Degree
Piotr Spychalski, PhD, MD
Phone
+48667843555
Email
piotr.spychalski@gumed.edu.pl

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs