incisional hernia Ventral abdominal wall hernia
Conditions
Interventions
Patients participating in this trial will be randomized to:
Treatment group A
The intervention group will receive a commercially available Prevena* Incision
Management System (Kinetic Concepts Inc
Sponsors
Amsterdam UMC
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: In order to participate in this trial, a subject must meet the following criteria: • >=18 years • Informed consent • Pre-operative CT available (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
Exclusion criteria: • Patients
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcome of the PRESSURE trial will be the percentage of patients with clinically relevant* SSO 38°C); localized pain or tenderness. A culture or non-culture based test that has a negative finding does not meet this criterion. c. An abscess or other evidence of infection involving the deep incision that is detected on gross anatomical, histopathologic exam, or imaging test • Wound cellulitis Defined as wound erythema treated with antibiotics without requiring manipulation or opening of the incision • Wound dehiscence Defined as the splitting apart of the margins of the wound in the absence of meeting SSI criteria, for which action has been undertaken (e.g. surgery) • Enterocutaneous fistulae Defined as a connection between bowel and abdominal wall not deliberately created during surgery • Seroma Defined as a seroma for which action has been undertaken (e.g. drainage/imaging, etc) • Hematoma Defined as a hematoma for which action has been undertaken (e.g. drainage/imaging, etc) • Skin ischemia/necrosis Defined as signs of ischemia (the six P*s: pain, pallor, pulseless, paraesthesia, paralysis, poikilothermia (not being able to regulate temperature) SSO monitoring Monitoring will take place with active patient-based surveillance by a combination of ante- and post-discharge surveillance methods: • Examination by the physician during admission and after discharge in the outpatient clinic at post-operative day 30 • Review of medical records • In case of suspicion of SSO after discharge the patient will be assessed in the outpatient clinic. Control patients will undergo the same amount of planned evaluations for SSO as the intervention group in order to prevent bias. | — |
Secondary
| Measure | Time frame |
|---|---|
| The following secondary outcomes will be assessed in the outpatient clinic at 30 and 90 days and 1 year after surgery: • The individual components of SSO at | — |
Countries
Belgium, Netherlands, Spain
Contacts
Public ContactF. Dieleman
Amsterdam UMC
Outcome results
None listed