Open Abdomen: Vacuum Pack Versus Sylo Bag and Mesh Protocol

Not Applicable

Completed

• Conditions: Open Abdomen; Temporary Abdominal Closure Mechanisms
• Interventions: Device: Vacuum Pack; Device: Double Sylo Bag - Mesh Protocol

• Registration Number: NCT01864590
• Lead Sponsor: Universidad de Antioquia

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2011-06
• Primary Completion: 2013-04
• Study First Submitted: 2013-05-19
• Study First Submitted QC: 2013-05-24
• Study First Posted: 2013-05-29
• Study Completion: 2013-06
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-26
• Last Update Posted: 2016-10-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

Inclusion Criteria

• Open Abdomen

Exclusion Criteria

• Patients that die in the first 48 hours after the initial intervention

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Open Abdomen - Vacuum Pack	Vacuum Pack	Patients that Require open abdomen
Double Sylo Bag - Mesh Protocol	Double Sylo Bag - Mesh Protocol	Open Abdomen

Primary Outcome Measures

Name	Time	Method
Fascial Closure Rate	Until hospital discharge Aprox 60 days

Secondary Outcome Measures

Name	Time	Method
Gastrointestinal Fistulas	Until hospital discharge Aprox. 60 days
Day of Fascial Closure	Until hospital discharge Aprox. 60 days
Length of Stay	Until hospital discharge Aprox. 60 days
Abdominal Abscess	Until hospital discharge Aprox. 60 days
Fascial Closure Dehiscence	Until hospital discharge Aprox. 60 days

Trial Locations

Locations (1)

Hospital Universitario San Vicente Fundacion; 🇨🇴 Medellin, Antioquia, Colombia