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Open Abdomen: Vacuum Pack Versus Sylo Bag and Mesh Protocol

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ClinicalTrials.gov Identifier: NCT01864590
Recruitment Status : Completed
First Posted : May 29, 2013
Last Update Posted : October 27, 2016
Sponsor:
Information provided by (Responsible Party):
Carlos Hernando Morales, Universidad de Antioquia

Brief 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.

Condition or disease Intervention/treatment Phase
Open Abdomen Temporary Abdominal Closure Mechanisms Device: Vacuum Pack Device: Double Sylo Bag - Mesh Protocol Not Applicable

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open Abdomen: Vacuum Pack Versus Sylo Bag and Mesh Protocol - A Randomized Trial
Study Start Date : June 2011
Actual Primary Completion Date : April 2013
Actual Study Completion Date : June 2013

Arm Intervention/treatment
Experimental: Open Abdomen - Vacuum Pack
Patients that Require open abdomen
Device: Vacuum Pack
Vacuum Pack Technique described by Barker et al.

Active Comparator: Double Sylo Bag - Mesh Protocol
Open Abdomen
Device: 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





Primary Outcome Measures :
  1. Fascial Closure Rate [ Time Frame: Until hospital discharge Aprox 60 days ]

Secondary Outcome Measures :
  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 ]


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Ages Eligible for Study:   13 Years to 96 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Open Abdomen

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01864590


Locations
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Colombia
Hospital Universitario San Vicente Fundacion
Medellin, Antioquia, Colombia
Sponsors and Collaborators
Universidad de Antioquia
Investigators
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Principal Investigator: Carlos H Morales, MD Universidad de Antioquia

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Carlos Hernando Morales, Chief Surgery Department, Universidad de Antioquia
ClinicalTrials.gov Identifier: NCT01864590     History of Changes
Other Study ID Numbers: University Of Antioquia
First Posted: May 29, 2013    Key Record Dates
Last Update Posted: October 27, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Carlos Hernando Morales, Universidad de Antioquia:
Open Abdomen
Negative Pressure Wound Therapy
Temporary Abdominal Closure
Mesh
Abdominal reconstruction