An observational study in Open Abdomen, sponsored by KCI USA, Inc. Completed at 11 sites in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-12-02.
Sponsored by KCI USA, Inc (part of Solventum) · Observational
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.
This study is being done to gather data that will be used to compare two different TAC (Temporary Abdominal Closure) methods. 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.
KCI USA, Inc is the lead sponsor of 18 studies on the registry; none are open to participants now.
First submitted before KCI USA, Inc became part of Solventum.
Counted across the registry records on this site, refreshed daily.
Emergent Care
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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):
Exclusion Criteria:
ABThera Open Abdomen Negative Pressure Therapy System
Also known as: ABThera
Barker's Vacuum Packing Technique
Number of Participants With Primary Fascial Closure
Time frame: Up to 30 days
| Milestone | NPWT | BVPT |
|---|---|---|
| Started | 180 | 103 |
| Completed | 178 | 102 |
| Not completed | 2 | 1 |
| Participants | NPWT | BVPT |
|---|---|---|
| Number of Participants With Primary Fascial Closure | 139 | 69 |
Collected over 30 day. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| NPWT | 21/178 (11.8%) | 3/180 (1.7%) | 65/180 (36.1%) |
| BVPT | 20/102 (19.6%) | 0/103 (0%) | 36/103 (35%) |
| Event | NPWT | BVPT |
|---|---|---|
| Abdominal Compartment SyndromeGastrointestinal disorders | 3/180 | 0/103 |
| Event | NPWT | BVPT |
|---|---|---|
| Intra-Abdominal HypertensionGastrointestinal disorders | 22/180 | 9/103 |
| Mulitple Organ Dysfunction SyndromeGeneral disorders | 12/180 | 12/103 |
| SepsisInfections and infestations | 16/180 | 11/103 |
| Abdominal InfectionInfections and infestations | 10/180 | 10/103 |
| Loss of Fascial DomainMusculoskeletal and connective tissue disorders | 14/180 | 9/103 |
| Intraloop AdhesionsGastrointestinal disorders | 15/180 | 1/103 |
| Gastrointestinal NecrosisGastrointestinal disorders | 12/180 | 2/103 |
| Abdominal AdhesionsGastrointestinal disorders | 9/180 | 6/103 |
| Age, Continuous(years) | NPWT | BVPT | Total |
|---|---|---|---|
| Mean | 40 ± 17 | 39 ± 16 | 40 ± 16 |
| Sex: Female, Male(Participants) | NPWT | BVPT | Total |
|---|---|---|---|
| Female | 36 | 28 | 64 |
| Male | 142 | 74 | 216 |
| Race/Ethnicity, Customized(Participants) | NPWT | BVPT | Total |
|---|---|---|---|
| Race/Ethnicity — American Indian | 1 | 1 | 2 |
| Race/Ethnicity — Asian | 4 | 3 | 7 |
| Race/Ethnicity — Black or African American | 54 | 40 | 94 |
| Race/Ethnicity — Hispanic or Latino | 37 | 10 | 47 |
| Race/Ethnicity — Native Hawaiian | 1 | 1 | 2 |
| Race/Ethnicity — White | 81 | 47 | 128 |
| Region of Enrollment(Participants) | NPWT | BVPT | Total |
|---|---|---|---|
| United States | 178 | 102 | 280 |
This study is completed, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.
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