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Open Abdomen: Vacuum Pack Versus Sylo Bag and Mesh Protocol

U

Universidad de Antioquia

Status

Completed

Conditions

Open Abdomen
Temporary Abdominal Closure Mechanisms

Treatments

Device: Vacuum Pack
Device: Double Sylo Bag - Mesh Protocol

Study type

Interventional

Funder types

Other

Identifiers

NCT01864590
University Of Antioquia

Details and patient eligibility

About

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.

Full 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.

Enrollment

52 patients

Sex

All

Ages

13 to 96 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Open Abdomen

Exclusion criteria

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

52 participants in 2 patient groups

Open Abdomen - Vacuum Pack
Experimental group
Description:
Patients that Require open abdomen
Treatment:
Device: Vacuum Pack
Double Sylo Bag - Mesh Protocol
Active Comparator group
Description:
Open Abdomen
Treatment:
Device: Double Sylo Bag - Mesh Protocol

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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