- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02519192
The Role of VAC Therapy Devices in Promoting Closure of Enterocutaneous Fistulae (ECF)
The Role of VAC Therapy Devices in Promoting Closure of Enterocutaneous Fistulae: A Randomized Controlled Trial
Study Overview
Status
Conditions
Detailed Description
Investigators are planning a superiority trial to show that VAC use speeds the closure of enterocutaneous fistulae over routine gravity drainage. The investigators' design is a randomized controlled trial with two arms. One of the arms (non-VAC) will include patients assigned to a system of ECFoutput management which does not involve negative pressure (for example, an ostomy bag placed over the fistula, wet to dry dressing changes, etc..), and the second arm (VAC) will consist of a group of patients assigned to VAC negative pressure therapy with regular sponge irrigation with normal saline (the V.A.C.Ulta™ Negative Pressure Wound Therapy System) .
The fistula vac is made from standard sponge supplies and negative pressure suction devices. Initial placement will be by the bedside physician in the intensive care unit, the ward, or in the clinic. The patient will be taught basic wound care, and as is typical for those outpatients with wound VACs, a home nursing aide will be arranged. Those randomized to no VAC therapy will have ostomy bags or wet to dry dressings placed on the skin with no negative pressure applied. Again, initial application will be performed by the bedside physician or a wound care nurse. The patient will be taught wound care, with assistance provided as necessary.
Once a fistula is noted to have closed (effluent = 0cc/day) the dressings or VAC will be discontinued, and the date of fistula closure noted.
Study Type
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Colorado
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Denver, Colorado, United States, 80204
- Denver Health Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- post-laparotomy patient developing a new enterocutaneous fistula
Exclusion Criteria:
- patient with a prior history of abdominal radiation
- patient with a distal obstruction, any entero-atmospheric fistula, or any patient with a history of intra-abdominal or metastatic cancer.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: VAC Arm, Vac sponge irrigations
For patients who fall under the VAC arm, a physician will do the initial placement of the wound VAC (V.A.C.Ulta™ Negative Pressure Wound Therapy System) at the patient's bedside.
An information sheet will be provided to the patient, and the patient will be taught how to irrigate the sponge system independently.
While inpatient, nursing will perform VAC sponge irrigation.
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VAC Arm will consist of a group of patients assigned to VAC negative pressure therapy with regular sponge irrigation with normal saline (the V.A.C.Ulta™ Negative Pressure Wound Therapy System) .
VAC Arm will consist of a group of patients assigned to VAC negative pressure therapy with regular sponge irrigation with normal saline (the V.A.C.Ulta™ Negative Pressure Wound Therapy System) .
|
Active Comparator: NonVac, ostomy bag, wet to dry dressings
For patients who fall under the non-VAC arm, a physician or wound care nurse will perform the initial application of the ostomy bag or wet to dry dressing change.
An information sheet will be provided to the patient.
While inpatient, members from the nursing or physician team will perform ostomy bag application and ostomy dressing changes.
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Non Vac Arm will receive ostomy bag applications.
Non Vac arm will receive wet to dry dressing changes.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
primary endpoint of time to fistula closure
Time Frame: Expected average of 6-8 weeks
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Study subjects will be followed until closure of the enterocutaneous fistula, an expected average of 6-8 weeks.
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Expected average of 6-8 weeks
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Fredric M Pieracci, MD MPH, Denver Health Medical Center
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 15-2133
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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