Ignite Creation Date:
2025-12-25 @ 1:10 AM
Ignite Modification Date:
2025-12-31 @ 4:51 AM
Study NCT ID:
NCT00494793
Status:
COMPLETED
Last Update Posted:
2017-12-29
First Post:
2007-06-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Vacuum Assisted Wound Closure (VAWC) and Mesh Mediated Fascial Traction
Sponsor:
Skane University Hospital
Organization:
Study Overview
Official Title:
Vacuum Assisted Wound Closure (VAWC) and Mesh Mediated Fascial Traction - Prospective Study of a Novel Technique for Open Abdomen Closure
Status:
COMPLETED
Status Verified Date:
2017-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
Detailed Description:
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: