Open Abdomen: Vacuum Pack Versus Sylo Bag and Mesh Protocol

Open Abdomen Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01864590
• Other study ID #: University Of Antioquia
• Status: Completed
• Phase: N/A
• First received: May 19, 2013
• Last updated: October 26, 2016
• Start date: June 2011
• Est. completion date: June 2013

Study information

• Verified date: October 2016
• Source: Universidad de Antioquia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Colombia: Ministry of Health and Social Protection
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Open Abdomen
• Temporary Abdominal Closure Mechanisms

Intervention

Device:
• Vacuum Pack
Vacuum Pack Technique described by Barker et al.
• 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

Locations

Country	Name	City	State
Colombia	Hospital Universitario San Vicente Fundacion	Medellin	Antioquia

Sponsors (1)

Lead Sponsor	Collaborator
Universidad de Antioquia

Country where clinical trial is conducted

Colombia, 

Outcome

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