Open Abdomen: Vacuum Pack Versus Sylo Bag and Mesh Protocol

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

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.

Study Overview

• Status: Completed
• Conditions: Open Abdomen; Temporary Abdominal Closure Mechanisms
• Intervention / Treatment: Device: Vacuum Pack; Device: Double Sylo Bag - Mesh Protocol

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.

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Colombia
  • Antioquia
    • Medellin, Antioquia, Colombia
      • Hospital Universitario San Vicente Fundación

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years to 96 years (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Open Abdomen

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Universidad de Antioquia
• Investigators: Principal Investigator: Carlos H Morales, MD, Universidad de Antioquia

Publications and helpful links

General Publications

• Correa JC, Mejia DA, Duque N, J MM, Uribe CM. Managing the open abdomen: negative pressure closure versus mesh-mediated fascial traction closure: a randomized trial. Hernia. 2016 Apr;20(2):221-9. doi: 10.1007/s10029-016-1459-9. Epub 2016 Feb 1.

Study record dates

Study Major Dates

• Study Start: June 1, 2011
• Primary Completion (ACTUAL): April 1, 2013
• Study Completion (ACTUAL): June 1, 2013

Study Registration Dates

• First Submitted: May 19, 2013
• First Submitted That Met QC Criteria: May 24, 2013
• First Posted (ESTIMATE): May 29, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): October 27, 2016
• Last Update Submitted That Met QC Criteria: October 26, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: Mesh; Negative Pressure Wound Therapy; Open Abdomen; Temporary Abdominal Closure; Abdominal reconstruction
• Other Study ID Numbers: University Of Antioquia

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO