Open AbdomenNCT01016353
Open Abdomen Study Comparing ABThera™ Open Abdomen Negative Pressure Therapy System and Barker's Vacuum Packing Technique
An observational study of Open Abdomen, run by KCI USA, Inc at 11 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Open Abdomen
- What is being tested?
- NPWT and BVPT
- Type of treatment
- Medical device
- How many people
- 283 participants
- Where
- 11 sitesUnited States
- Study dates
- Dec 2009to Jan 2011
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Emergent Care
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
University of Maryand
Baltimore, Maryland, 21201
Cook County Medical Center
Chicago, Illinois, 60612
LAC/USC Medical Center
Los Angeles, California, 90033
Regional Medical Center
Memphis, Tennessee, 38163
University of South Alabama Medical Center
Mobile, Alabama, 36617
Tulane Medical Center
New Orleans, Louisiana, 70117
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73117
Orlando Regional Medical Center
Orlando, Florida, 32806
Albert Einstein Medical Center
Philadelphia, Pennsylvania, 19006
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Oregon Health & Science University
Portland, Oregon, 97239
About this study
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
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.
Read the detailed description
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.
- Conditions
- Open Abdomen
- Being tested
- NPWT, BVPT
- Keywords
- ABThera, Barker's Vacuum Packing Technique
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NPWTDevice
Also called ABThera
ABThera Open Abdomen Negative Pressure Therapy System
BVPTDevice
Barker's Vacuum Packing Technique
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Primary Fascial Closure
Measured: Up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2009 (estimated)
- Study startDec 2009
- Primary completionJan 2011
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Open AbdomenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 283 participants (actual)
Sponsor and investigators
- Lead sponsor
- KCI USA, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01016353
- Sponsor's protocol ID
- ABT2009-50
- Status last verified
- Nov 2024
- First submitted
- 18 Nov 2009
- Last updated
- 2 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Bjorck M, Kirkpatrick AW, Cheatham M, Kaplan M, Leppaniemi A, De Waele JJ. Amended Classification of the Open Abdomen. Scand J Surg. 2016 Mar;105(1):5-10. doi: 10.1177/1457496916631853. Epub 2016 Feb 29.
PubMed 26929286
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01016353
- Acronym / sponsor ID
- ABT2009-50
- Conditions
- Open Abdomen
- Keywords
- ABThera, Barker's Vacuum Packing Technique
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 283 participants (actual)
- Lead sponsor
- KCI USA, IncIndustry (pharma, biotech, devices)
- Study start
- Dec 2009
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 19 Nov 2009 (estimated)
- Results
- Posted 3 Jan 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Emergent Care
Key inclusion criteria (4 listed)
- 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):
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NPWTAlso: ABTheraABThera Open Abdomen Negative Pressure Therapy System | Device | – |
| BVPTBarker's Vacuum Packing Technique | Device | – |
Primary outcome
Number of Participants With Primary Fascial Closure
Time frame: Up to 30 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 26929286Bjorck M, Kirkpatrick AW, Cheatham M, Kaplan M, Leppaniemi A, De Waele JJ. Amended Classification of the Open Abdomen. Scand J Surg. 2016 Mar;105(1):5-10. doi: 10.1177/1457496916631853. Epub 2016 Feb 29.
Related trials for Open Abdomen
Recruiting
Implementation of a Pain Management Plan in Major Open Abdominal Surgeries.
Abdomen Cancer, Pancreas Adenocarcinoma (MSI-H)
Recruiting
Management of Abdominal Post-surgical Scar With Ozoaqua Versus Standard Care
Wound Healing, Abdominal Surgery
Active, not recruitingPhase 2
Intravenous Ibuprofen Postoperative Analgesia After Abdominal Hysterectomy
Post Operative Analgesia
Recruiting
Permanent Versus Slowly Dissolving Stitches for Non-Mesh (Shouldice) Groin Hernia Repair
Inguinal Hernia
Active, not recruitingPhase 2
CEB-01 in Pediatrics With Locally Resectable Abdominal Tumors
Locally Resectable Pediatrics Tumors
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Open Abdomen, run by KCI USA, Inc at 11 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Jan 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Primary Fascial Closure (time frame: Up to 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01016353, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2024.