Open AbdomenNCT01864590
Open Abdomen: Vacuum Pack Versus Sylo Bag and Mesh Protocol
A study testing Vacuum Pack and Double Sylo Bag - Mesh Protocol in people with Open Abdomen and Temporary Abdominal Closure Mechanisms, run by Universidad de Antioquia at 1 site in Colombia.
Trial 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. Read more about this study
- Who is it for?
- Ages 13 to 96 yearsHealthy volunteers can take part
- Conditions the study is for
- Open Abdomen, Temporary Abdominal Closure Mechanisms
- What is being tested?
- Vacuum Pack and Double Sylo Bag - Mesh Protocol
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteColombia
- Study dates
- Jun 2011to Jun 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 96 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Open Abdomen
Who cannot join
- Patients that die in the first 48 hours after the initial intervention
Trial locations and contacts
1 site in 1 country.
Colombia1 site
Hospital Universitario San Vicente Fundacion
Medellín, Antioquia
About this study
Official title: 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.
Read the 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.
- Being tested
- Vacuum Pack, Double Sylo Bag - Mesh Protocol
- Keywords
- Open Abdomen, Negative Pressure Wound Therapy, Temporary Abdominal Closure, Mesh, Abdominal reconstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vacuum PackDevice
Vacuum Pack Technique described by Barker et al.
Double Sylo Bag - Mesh ProtocolDevice
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
| Study group | Role | What they receive |
|---|---|---|
| Open Abdomen - Vacuum Pack | Experimental | Patients that Require open abdomen Receives: Device: Vacuum Pack |
| Double Sylo Bag - Mesh Protocol | Active comparator | Open Abdomen Receives: Device: Double Sylo Bag - Mesh Protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fascial Closure Rate
Measured: Until hospital discharge Aprox 60 days
Secondary outcomes (5)
Gastrointestinal Fistulas
Measured: Until hospital discharge Aprox. 60 days
Abdominal Abscess
Measured: Until hospital discharge Aprox. 60 days
Fascial Closure Dehiscence
Measured: Until hospital discharge Aprox. 60 days
Length of Stay
Measured: Until hospital discharge Aprox. 60 days
Day of Fascial Closure
Measured: Until hospital discharge Aprox. 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2013 (estimated)
- Study startJun 2011
- Primary completionApr 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Open AbdomenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Antioquia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carlos Hernando Morales, Universidad de Antioquia
- Investigators
- Carlos H Morales, MD, Principal investigator, Universidad de Antioquia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01864590
- Sponsor's protocol ID
- University Of Antioquia
- Status last verified
- Oct 2016
- First submitted
- 19 May 2013
- Last updated
- 27 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
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.
PubMed 26833235
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Abdomen: Vacuum Pack Versus Sylo Bag and Mesh Protocol - A Randomized Trial
- ClinicalTrials.gov ID
- NCT01864590
- Acronym / sponsor ID
- University Of Antioquia
- Keywords
- Open Abdomen, Negative Pressure Wound Therapy, Temporary Abdominal Closure, Mesh, Abdominal reconstruction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Universidad de AntioquiaUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- Apr 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 29 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Open Abdomen - Vacuum Pack | Experimental | Device: Vacuum PackPatients that Require open abdomen |
| Double Sylo Bag - Mesh Protocol | Active comparator | Device: Double Sylo Bag - Mesh ProtocolOpen Abdomen |
Who may qualify
- Ages
- 13 to 96 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Open Abdomen
Key exclusion criteria (1 listed)
- Patients that die in the first 48 hours after the initial intervention
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vacuum PackVacuum Pack Technique described by Barker et al. | Device | Open Abdomen - Vacuum Pack |
| Double Sylo Bag - Mesh Protocoldouble 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 | Device | Double Sylo Bag - Mesh Protocol |
Primary outcome
Fascial Closure Rate
Time frame: Until hospital discharge Aprox 60 days
5 secondary outcomes
Gastrointestinal Fistulas
Time frame: Until hospital discharge Aprox. 60 days
Abdominal Abscess
Time frame: Until hospital discharge Aprox. 60 days
Fascial Closure Dehiscence
Time frame: Until hospital discharge Aprox. 60 days
Length of Stay
Time frame: Until hospital discharge Aprox. 60 days
Day of Fascial Closure
Time frame: Until hospital discharge Aprox. 60 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2016.
- Derived from this study: PubMed 26833235Correa 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carlos H Morales, MD principal investigator
Universidad de Antioquia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vacuum Pack and Double Sylo Bag - Mesh Protocol in people with Open Abdomen and Temporary Abdominal Closure Mechanisms, run by Universidad de Antioquia at 1 site in Colombia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fascial Closure Rate (time frame: Until hospital discharge Aprox 60 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01864590, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2016.