Open Abdomen Clinical Trial
Official title:
Vacuum Assisted Wound Closure (VAWC) and Mesh Mediated Fascial Traction - Prospective Study of a Novel Technique for Open Abdomen Closure
The purpose of this multicenter trial is to prospectively evaluate a novel combination of vacuum assisted wound closure (VAWC) and mesh mediated fascial traction for closure of open abdomens.
Open abdomen treatment often results in difficulties in closing the abdomen. Highest closure
rates are seen with the vacuum assisted wound closure (VAWC) technique. Failures with this
technique is occasionally experienced, especially in cases with severe visceral swelling
needing longer treatment periods with open abdomen. A novel combination of vacuum assisted
wound closure and mesh mediated fascial traction for managing the open abdomen was therefore
developed and initially tested in a small pilot-like study with encouraging results with late
primary closure of the abdomens in all seven patients.
In this multicenter study we prospectively evaluate the technique.
Inclusion criteria:
All patients treated with open abdomen at the 4 participating hospitals are registered, and
only those patients who have commenced therapy with VAWC and mesh mediated fascial traction
will be included in the study in an intention to treat model.
Exclusion criteria:
Treatment of open abdomen with other techniques.
Method:
- The first period of 2-5 days only the abdominal VAWC dressing is applied.
- On day 3-10 a polypropylene mesh is sutured to the fascial edges, between the two layers
of the VAWC system, and tightened.
- The VAWC dressing is changed and the mesh tightened every 2-3 days, resulting in gradual
approximation of the fascial edges.
- Finally the mesh is removed and the fascia is closed.
- At closure the wound to suture length is registered.
Primary endpoint:
Frequency of primary fascial closure.
Secondary endpoints:
- study of factors associated with failure of fascial closure and in-hospital mortality,
- abdominal pressure variation attributable to the use of the technique,
- duration of treatment with open abdomen,
- frequency of incisional hernia after one and five years.
Duration of the study:
3-5 years. Enrollment of open abdomen cases.
Follow-up schedule for patients:
- Clinical evaluation at 1 and 5 years.
- CT-examination at 1 year.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT00754156 -
ABRA Abdominal Closure System in Open Abdomen Management
|
Phase 4 | |
Not yet recruiting |
NCT05568238 -
Vacuum Assisted Wound Closure and Permanent On-lay Mesh-mediated Fascial Traction in Patients With Open Abdomen
|
N/A | |
Completed |
NCT01968811 -
Post Market Clinical Follow Up Study of Avance Foam Abdominal Dressing Kit in Open Abdomen
|
N/A | |
Completed |
NCT01864590 -
Open Abdomen: Vacuum Pack Versus Sylo Bag and Mesh Protocol
|
N/A | |
Withdrawn |
NCT01010464 -
An Adhesion Reduction Plan in the Management of the Surgical Open Abdomen
|
N/A | |
Recruiting |
NCT06428370 -
Damage Control Surgery Over the World in Acute Diverticulitis (DACOSAD)
|
||
Recruiting |
NCT04283916 -
Botulinum Toxin Injection in the Treatment of Open Abdomen
|
||
Terminated |
NCT00834314 -
Randomized Pilot Study Comparing Two Vacuum-wound-dressings for Open Abdomen Treatment
|
N/A | |
Recruiting |
NCT06242925 -
Assessment of a Non-invasive Device in the Management of Open Abdomen (AbCLO)
|
N/A | |
Completed |
NCT01016353 -
Open Abdomen Study Comparing ABTheraâ„¢ Open Abdomen Negative Pressure Therapy System and Barker's Vacuum Packing Technique
|
||
Completed |
NCT01594385 -
Seprafilm in Open Abdomens: a Study of Wound and Adhesion Characteristics in Trauma Damage Control Patients
|
N/A |