NCT01864590

Open Abdomen: Vacuum Pack Versus Sylo Bag and Mesh Protocol

Open Abdomen: Vacuum Pack Versus Sylo Bag and Mesh Protocol - A Randomized Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: Universidad de Antioquia · Academic / Other
• Sex: All
• Age: 13 Years – 96 Years
• Healthy volunteers: Accepted

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.

Conditions

• Open Abdomen
• Temporary Abdominal Closure Mechanisms

Interventions

Type	Name	Description
DEVICE	Vacuum Pack	Vacuum Pack Technique described by Barker et al.
DEVICE	Double Sylo Bag - Mesh Protocol	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. This mesh is resutured every day until the abdominal fascia is approximated enough to permit closure

Timeline

• Start date: 2011-06-01
• Primary completion: 2013-04-01
• Completion: 2013-06-01
• First posted: 2013-05-29
• Last updated: 2016-10-27

Locations

1 site across 1 country: Colombia