Open Abdomen: Vacuum Pack Versus Sylo Bag and Mesh Protocol

NCT ID: NCT01864590

Last Updated: 2016-10-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-06-30
• Study Completion Date: 2013-06-30

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.

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.

Conditions

Open Abdomen; Temporary Abdominal Closure Mechanisms

Keywords

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Open Abdomen - Vacuum Pack

Patients that Require open abdomen

Group Type: EXPERIMENTAL

Vacuum Pack

Intervention Type: DEVICE

Vacuum Pack Technique described by Barker et al.

Double Sylo Bag - Mesh Protocol

Open Abdomen

Group Type: ACTIVE_COMPARATOR

Double Sylo Bag - Mesh Protocol

Intervention Type: 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

Interventions

Vacuum Pack

Vacuum Pack Technique described by Barker et al.

Intervention Type: 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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Open Abdomen

Exclusion Criteria

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

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 96 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Universidad de Antioquia

OTHER

Sponsor Role: lead

Responsible Party

Carlos Hernando Morales

Chief Surgery Department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Carlos H Morales, MD

Role: PRINCIPAL_INVESTIGATOR

Universidad de Antioquia

Locations

Hospital Universitario San Vicente Fundacion

Medellín, Antioquia, Colombia

Countries

Colombia

References

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.

Reference Type: DERIVED

PMID: 26833235 (View on PubMed)

Other Identifiers

University Of Antioquia

Identifier Type: -

Identifier Source: org_study_id