Clinical trial NCT01864590: Open Abdomen: Vacuum Pack Versus Sylo Bag and Mesh Protocol
Official title: Open Abdomen: Vacuum Pack Versus Sylo Bag and Mesh Protocol - A Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Open Abdomen
Temporary Abdominal Closure Mechanisms
Keywords: Open Abdomen
Negative Pressure Wound Therapy
Temporary Abdominal Closure
Mesh
Abdominal reconstruction
Lead sponsor: Universidad de Antioquia
Sponsor class: OTHER
First posted: 2013-05-29
Enrollment: 52
Sex: ALL
Minimum age (years): 13
Maximum age (years): 96
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* Open Abdomen

Exclusion Criteria:

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

Primary outcomes:
measure: Fascial Closure Rate
timeFrame: Until hospital discharge Aprox 60 days
Secondary outcomes:
measure: Gastrointestinal Fistulas
timeFrame: Until hospital discharge Aprox. 60 days
measure: Abdominal Abscess
timeFrame: Until hospital discharge Aprox. 60 days
measure: Fascial Closure Dehiscence
timeFrame: Until hospital discharge Aprox. 60 days
measure: Length of Stay
timeFrame: Until hospital discharge Aprox. 60 days
measure: Day of Fascial Closure
timeFrame: Until hospital discharge Aprox. 60 days
Other outcomes:
Locations:
city: Medellin
country: Colombia
facility: Hospital Universitario San Vicente Fundacion
state: Antioquia
Study officials:
affiliation: Universidad de Antioquia
name: Carlos H Morales, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.