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Completed

NCT Number: NCT01864590

Open Abdomen: Vacuum Pack Versus Sylo Bag and Mesh Protocol

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.

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Key information

Conditions

Open Abdomen Temporary Abdominal Closure Mechanisms

Age range

13 year–96 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Universitario San Vicente Fundacion

Medellín, Antioquia, Colombia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Open Abdomen

Exclusion criteria

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

Treatment and study plan

Vacuum Pack

Device

Vacuum Pack Technique described by Barker et al.

Double Sylo Bag - Mesh Protocol

Device

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

Primary outcomes

  1. Fascial Closure Rate

    Time frame: Until hospital discharge Aprox 60 days

Secondary outcomes

  1. Gastrointestinal Fistulas

    Time frame: Until hospital discharge Aprox. 60 days

  2. Abdominal Abscess

    Time frame: Until hospital discharge Aprox. 60 days

  3. Fascial Closure Dehiscence

    Time frame: Until hospital discharge Aprox. 60 days

  4. Length of Stay

    Time frame: Until hospital discharge Aprox. 60 days

  5. Day of Fascial Closure

    Time frame: Until hospital discharge Aprox. 60 days

Sponsors and collaborators

Lead sponsor

Universidad de Antioquia

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
May 29, 2013
Registry last updated
Oct 27, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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