PREventing Surgical Site occurrences using negative pressURE wound therapy

Phase 4

Recruiting

• Conditions: incisional hernia; Ventral abdominal wall hernia; 10000073; 10004018; 10040795

• Registration Number: NL-OMON56300
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 190

Inclusion Criteria

In order to participate in this trial, a subject must meet the following
criteria:
• >=18 years
• Informed consent
• Pre-operative CT available (< 12 months of surgery)
• Scheduled for elective, open abdominal wall reconstruction*, And one of the
following:
• A stoma** or enterocutaneous fistula and an abdominal wall defect*** of >6
cm**** on CT
• Violation of the gastrointestinal tract and an abdominal wall defect of >6 cm
on CT
• Infected or exposed mesh (any size)
• Open abdomens with contamination***** (any size), * Operative treatments
may include transversus abdominis release, endoscopic external oblique release
or open external oblique release, as long as the abdominal wall reconstruction
is open. Reconstructions incorporating the pedicled or free transfer of tissue
(e.g. an antero-lateral thigh or latissimus dorsi flap) are included as well.
, ** This includes jejunostomy, ileostomy, colostomy and Bricker stomata. ,
*** Abdominal wall defect is defined as:
**any abdominal wall gap with or without a bulge perceptible by imaging*
This definition is a modification of the definition proposed by the EHS for
incisional hernia recurrence., ****In case of parastomal hernia and the patient
is candidate for ostomy takedown or relocation, the resulting defect in the
abdominal wall should be taken for this measure, ***** Contamination is defined
as CDC Surgical Wound Class II (potentially contaminated) to IV
(dirty/infected).

Exclusion Criteria

• Patients <18
• Parastomal hernias planned for reconstruction using a local (or laparoscopic)
approach without a laparotomy*, *In case of a patient scheduled for
reconstruction of both incisional hernia and a parastomal hernia, the
reconstruction of the incisional hernia will be eligible for randomization. If
a parastomal hernia is approached through a laparotomy, the laparotomy incision
will be eligible for randomization.

Study & Design

• Study Type: Interventional
• Study Design: Not specified