Open Abdomen Clinical Trial
Official title:
Open Abdomen: Vacuum Pack Versus Sylo Bag and Mesh Protocol - A Randomized Trial
The open abdomen is a valid and accepted surgical tactic for the trauma and acute care patient. There have been many mechanisms described for its management, but the most accepted strategy is the vacuum pack. At our hospital the investigators have used for many years a double sylo bag, one underneath the fascia and the other sutured to the skin, at the initial operation. At subsequent surgeries once the abdomen is clean the investigators leave the same subfascial sylo bag and use a prolene mesh attached to the fascia. Every day the investigators try to tighten the mesh with sutures until the abdomen can be closed. This study´s objective is to compare our double sylo bag- mesh protocol with the vacuum pack to determine which is related to a higher fascial closure rate.
Status | Completed |
Enrollment | 52 |
Est. completion date | June 2013 |
Est. primary completion date | April 2013 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 13 Years to 96 Years |
Eligibility |
Inclusion Criteria: - Open Abdomen Exclusion Criteria: - Patients that die in the first 48 hours after the initial intervention |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Colombia | Hospital Universitario San Vicente Fundacion | Medellin | Antioquia |
Lead Sponsor | Collaborator |
---|---|
Universidad de Antioquia |
Colombia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Fascial Closure Rate | Until hospital discharge Aprox 60 days | No | |
Secondary | Gastrointestinal Fistulas | Until hospital discharge Aprox. 60 days | Yes | |
Secondary | Abdominal Abscess | Until hospital discharge Aprox. 60 days | No | |
Secondary | Fascial Closure Dehiscence | Until hospital discharge Aprox. 60 days | No | |
Secondary | Length of Stay | Until hospital discharge Aprox. 60 days | No | |
Secondary | Day of Fascial Closure | Until hospital discharge Aprox. 60 days | No |
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 | |
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 | |
Completed |
NCT00494793 -
Vacuum Assisted Wound Closure (VAWC) and Mesh Mediated Fascial Traction
|
N/A |