Open Abdomen: Vacuum Pack Versus Sylo Bag and Mesh Protocol

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Open Abdomen, Temporary Abdominal Closure Mechanisms

Intervention / Treatment
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* Device: Vacuum Pack
* Device: Double Sylo Bag - Mesh Protocol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Open Abdomen Exclusion Criteria: Patients that die in the first 48 hours after the initial intervention

Ages Eligible for Study
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Minimum Age: 13 Years
Maximum Age: 96 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Open Abdomen - Vacuum Pack<br>Patients that Require open abdomen | Device: Vacuum Pack<br>* Vacuum Pack Technique described by Barker et al.<br>|
| Active Comparator: Double Sylo Bag - Mesh Protocol<br>Open Abdomen | Device: Double Sylo Bag - Mesh Protocol<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fascial Closure Rate |  | Until hospital discharge Aprox 60 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gastrointestinal Fistulas |  | Until hospital discharge Aprox. 60 days | 
| Abdominal Abscess |  | Until hospital discharge Aprox. 60 days | 
| Fascial Closure Dehiscence |  | Until hospital discharge Aprox. 60 days | 
| Length of Stay |  | Until hospital discharge Aprox. 60 days | 
| Day of Fascial Closure |  | Until hospital discharge Aprox. 60 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Open Abdomen, Negative Pressure Wound Therapy, Temporary Abdominal Closure, Mesh, Abdominal reconstruction