CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 283 enrolled
Drug / intervention
NPWT +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01016353
NCT01016353N/ACompleted

A Prospective Study Examining Clinical Outcomes Associated With the Management of the Open Abdomen With the ABThera™ Open Abdomen Negative Pressure Therapy System and Barker's Vacuum Packing Technique

KCI USA, Inc·observational·Posted Nov 19, 2009·Updated Dec 2, 2024

In Brief

An observational study evaluating NPWT and BVPT for Open Abdomen. Completed, enrolled 283 participants across 11 sites.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsOpen Abdomen
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedNov 19, 2009
Enrollment StartDec 1, 2009
Primary CompletionJan 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 16.6 years ago

Interventions

NPWTdevice

ABThera Open Abdomen Negative Pressure Therapy System

BVPTdevice

Barker's Vacuum Packing Technique