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NCT01016353 · ClinicalTrials.gov registry record
Open Abdomen Study Comparing ABThera™ Open Abdomen Negative Pressure Therapy System and Barker's Vacuum Packing Technique
A clinical trial, sponsored by KCI USA.
- Completed
- Registry status
- 283
- Enrollment target
NCT01016353 is a clinical trial that has completed, run by KCI USA. The registered enrollment target is 283 participants.
The verdict
NCT01016353 has completed, sponsored by KCI USA.
- COMPLETED
- Registry status
- 283 participants
- Enrollment target
Study 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.
Interventions
- DEVICE NPWT
- DEVICE BVPT
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 283 participants |
| Start Date | 2009-12 |
| Est. Completion | 2011-01 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01016353
The ClinicalTrials.gov registry entry for NCT01016353 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 283 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is KCI USA, which has 11 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which NPWT is the first listed.
NCT01016353 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01016353 about?
NCT01016353 is a clinical study titled "Open Abdomen Study Comparing ABThera™ Open Abdomen Negative Pressure Therapy System and Barker's Vacuum Packing Technique". 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) ...
What is the current status of trial NCT01016353?
This trial is currently completed. The enrollment target is 283 participants. The study started on 2009-12. Estimated completion is 2011-01.
What interventions are being tested in trial NCT01016353?
The interventions under investigation include: NPWT (DEVICE), BVPT (DEVICE).
Who is sponsoring clinical trial NCT01016353?
This trial is sponsored by KCI USA, which has 11 total clinical trials registered on ClinicalTrials.gov.
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