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.
The Investigators plan to compare our double sylo-mesh protocol with the vacuum pack technique described by Barker et al. To accomplish this they have designed a randomized trial that will include patients that require an open abdomen strategy according to their attending physician either due to a traumatic or a medical cause. Once the surgeon decides to leave the abdomen open, one of the nurses will pick up an envelope from the randomization box and read out loud the patients allocation (Vacuum pack or Double sylo bag-mesh protocol) . During subsequent surgeries the patient must continue with the same strategy for a minimum of 21 days or until fascial closure. The patients will be followed during their whole hospital stay to determine complication rates and fascial closures. ;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Withdrawn |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 |