N/A
N=283
Open Abdomen Study Comparing ABThera™ Open Abdomen Negative Pressure Therapy System and Barker's Vacuum Packing Technique
Open Abdomen
Bottom Line
View on ClinicalTrials.gov: NCT01016353 ↗Enrolled (actual)
283
Serious AEs
1.1%
Results posted
Jan 2018
Primary outcome: Primary: Number of Participants With Primary Fascial Closure — 139; 69 Participants — p=0.06
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- NPWT (Device); BVPT (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- KCI USA, Inc
- Primary completion
- Jan 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Primary Fascial Closure |
139; 69 | 0.06 |
Summary
This study is being done to gather data that will be used to compare two different TAC (Temporary Abdominal Closure) methods that your doctor may use. The two TAC methods being compared are the Barker's vacuum packing technique or BVPT and the Open Abdomen Negative Pressure Therapy System (ABThera) developed by the sponsor of this research (KCI, San Antonio, TX). The BVPT is made up of supplies that are stocked in most surgery rooms. The ABThera dressing is available commercially. Neither method will be supplied to the doctor (Principal Investigator), so that in no way would the subject's standard of care be different from what they would get if the study was not being done.
This study is observational and only collects data about how the subject progresses after surgery TAC is used. When a study is observational it means that the subject's standard medical care will not be altered in any way, simply watched. The doctor will not change treatment of your open abdomen.
Eligibility Criteria
Inclusion Criteria
- Subjects 18-75 years of age
- OA Subjects treated with only one of the following TACs at initial placement (defined as the time of the first application of a TAC method):
- ABThera
- BVPT
Exclusion Criteria
- Pregnant females
- Active, uncontrolled hemorrhage at the time of TAC placement
- Diagnosis of pre-existing bleeding disorder
- Known allergy or hypersensitivity to polyvinyl, polyurethane, acrylic, or acrylic adhesive
- Subjects with fistulas
- Subjects who have been enrolled in this study previously
- Documented history of Child-Pugh Turcot Liver Dysfunction - Class C (10-15 points) at the time of enrollment
- Subjects with body mass index (BMI) > 40 as estimated at the time of Emergency Department (ED) or OR admission
- Known New York Heart Association Functional Classification - Class IV at the time of enrollment
Data sourced from ClinicalTrials.gov (NCT01016353). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.