Open Abdomen: Vacuum Pack Versus Sylo Bag and Mesh Protocol

NCT01864590 | Completed

• 1 other identifier: University Of Antioquia
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Open Abdomen; Temporary Abdominal Closure Mechanisms

Keywords

Open Abdomen; Negative Pressure Wound Therapy; Temporary Abdominal Closure; Mesh; Abdominal reconstruction

Outcome Measures

Primary Outcomes (1)

• Fascial Closure Rate

  Until hospital discharge Aprox 60 days

Secondary Outcomes (5)

• 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

Study Arms (2)

Open Abdomen - Vacuum Pack

EXPERIMENTAL

Patients that Require open abdomen

Device: Vacuum Pack

Double Sylo Bag - Mesh Protocol

ACTIVE COMPARATOR

Open Abdomen

Device: Double Sylo Bag - Mesh Protocol

Interventions

Vacuum Pack DEVICE

Vacuum Pack Technique described by Barker et al.

Open Abdomen - Vacuum Pack

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

Double Sylo Bag - Mesh Protocol

Eligibility Criteria

• Age: 13 Years - 96 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Open Abdomen

You may not qualify if:

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

Sponsors & Collaborators

• Universidad de Antioquia: lead

Study Sites (1)

Hospital Universitario San Vicente Fundacion

Medellín, Antioquia, Colombia

Location

Related Publications (1)

• 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.

  PMID: 26833235 DERIVED

Study Officials

• Carlos H Morales, MD

  Universidad de Antioquia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Surgery Department

Study Record Dates

• First Submitted: May 19, 2013
• First Posted: May 29, 2013
• Study Start: June 1, 2011
• Primary Completion: April 1, 2013
• Study Completion: June 1, 2013
• Last Updated: October 27, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will not share

Locations

CO (1)