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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01864590
Other study ID # University Of Antioquia
Secondary ID
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


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
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