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Completed No phase listed Observational Results available

Open Abdomen Study Comparing ABThera™ Open Abdomen Negative Pressure Therapy System and Barker's Vacuum Packing Technique

ClinicalTrials.gov ID: NCT01016353

Public ClinicalTrials.gov record NCT01016353. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 21, 2026, 9:56 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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 identification

NCT ID
NCT01016353
Recruitment status
Completed
Study type
Observational
Phase
Not listed
Lead sponsor
KCI USA, Inc
Industry
Enrollment
283 participants

Conditions and interventions

Conditions

Interventions

Device

Eligibility (public fields only)

Age range
18 Years to 75 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Dec 2009 (Type not available)
Primary completion
Jan 2011 (Actual)
Completion
Jan 2011 (Actual)
Last update posted
Dec 2, 2024

2009 – 2011

United States locations

U.S. sites
11
U.S. states
10
U.S. cities
10
Facility City State ZIP Site status
University of South Alabama Medical Center Mobile Alabama 36617 —
LAC/USC Medical Center Los Angeles California 90033 —
Orlando Regional Medical Center Orlando Florida 32806 —
Cook County Medical Center Chicago Illinois 60612 —
Tulane Medical Center New Orleans Louisiana 70117 —
University of Maryand Baltimore Maryland 21201 —
University of Oklahoma Health Sciences Center Oklahoma City Oklahoma 73117 —
Oregon Health & Science University Portland Oregon 97239 —
Albert Einstein Medical Center Philadelphia Pennsylvania 19006 —
University of Pennsylvania Philadelphia Pennsylvania 19104 —
Regional Medical Center Memphis Tennessee 38163 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01016353, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Dec 2, 2024 · Synced Oct 21, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT01016353 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →