Open AbdomenABDOVACNCT00834314
Randomized Pilot Study Comparing Two Vacuum-wound-dressings for Open Abdomen Treatment
A study testing Vacuum-Pack-technique for temporary abdominal closure and Abdominal-dressing-technique for temporary abdominal closure in people with Open Abdomen and Temporary Abdominal Closure, run by Universitätsmedizin Mannheim at 1 site in Germany.
Trial summary
The primary purpose of the study is to determine whether two vacuum-wound-dressing techniques (the so called "abdominal dressing" versus "vacuum-pack-technique") are equally effective in the treatment of open abdomen. Secondary purpose is the comparison of feasibility and economic aspects. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Open Abdomen, Temporary Abdominal Closure
- What is being tested?
- Vacuum-Pack-technique for temporary abdominal closure and Abdominal-dressing-technique for temporary abdominal closure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteGermany
- Study dates
- Feb 2010to May 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients indicated for open-abdomen-treatment by responsible consultant surgeon where vacuum-technique is judged technically possible
Who cannot join
- Technical reasons
- unjustified risk-benefit-ratio of manipulations necessary for application of vacuum-pack-technique or abdominal-dressing-technique
Trial locations and contacts
1 site in 1 country.
Germany1 site
University Medical Centre - Surgical Department
Mannheim, Baden-Wurttemberg, 68167
About this study
Official title: Vacuum-Therapy in Open Abdomen Treatment - Randomized Pilot-trial Comparing Fascial Closure and Survival With "Vacuum-Pack"-Technique vs. "Abdominal Dressing"
The primary purpose of the study is to determine whether two vacuum-wound-dressing techniques (the so called "abdominal dressing" versus "vacuum-pack-technique") are equally effective in the treatment of open abdomen.
Secondary purpose is the comparison of feasibility and economic aspects.
- Conditions
- Open Abdomen, Temporary Abdominal Closure
- Being tested
- Vacuum-Pack-technique for temporary abdominal closure, Abdominal-dressing-technique for temporary abdominal closure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vacuum-Pack-technique for temporary abdominal closureProcedure or surgery
Negative-pressure-wound-therapy applying a method described by Brock, Barker et al 1995: "Temporary Closure of Open Abdominal Wounds - the Vacuum Pack" (see citations).
Abdominal-dressing-technique for temporary abdominal closureProcedure or surgery
Also called V.A.C.® Abdominal Dressing System
Negative-pressure-wound-therapy for temporary abdominal closure applying a device of KCI International (V.A.C.® Abdominal Dressing System). see: http://www.kci-medical.com/kci/corporate/kcitherapies/vactherapy/dressings/abdominal/#
| Study group | Role | What they receive |
|---|---|---|
| Vacuum-pack | Experimental | see Interventions Receives: Procedure: Vacuum-Pack-technique for temporary abdominal closure |
| Abdominal dressing | Active comparator | see Interventions Receives: Procedure: Abdominal-dressing-technique for temporary abdominal closure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Failure of delayed abdominal fascial closure (non-prevented ventral hernia) and/or in-hospital-death of any cause (combined primary outcome)
Measured: until end of vacuum-therapy or death
Secondary outcomes (6)
vacuum-therapy-related morbidity/complications
Measured: until hospital dismissal or death
length of vacuum-therapy
Measured: until end of vacuum-therapy or death
costs of vacuum-therapy
Measured: until end of vacuum-therapy or death
total length of ICU-stay
Measured: until end of ICU-therapy or death
post-dismissal health-related quality of life (SF36 and EQ-5D questionnaire)
Measured: 12 weeks after hospital dismissal
recurrent hernia/abdominal wall dehiscence after initial facial closure during hospital stay
Measured: 12 weeks post hospital dismissal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2009 (estimated)
- Study startFeb 2010
- Primary completionMay 2014
- Study completionMay 2014
Why it stopped: extended obligations of amended medical device law in Germany 2010 did not allow to continue and complete the trial due to budget limitation
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitätsmedizin Mannheim
- Sponsor type
- University, hospital or other
- Collaborators
- German Research Foundation
- Responsible party
- Principal investigator, Prof Dr. Stefan Post, Universitätsmedizin Mannheim
- Investigators
- Stefan Post, Prof. Dr., Principal investigator, University Medical Center Mannheim, Germany, Surgical Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00834314
- Sponsor's protocol ID
- 2008-291 M-MA
- Acronym
- ABDOVAC
- Status last verified
- Dec 2015
- First submitted
- 2 Feb 2009
- Last updated
- 8 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Brock WB, Barker DE, Burns RP. Temporary closure of open abdominal wounds: the vacuum pack. Am Surg. 1995 Jan;61(1):30-5.
PubMed 7832378Barker DE, Green JM, Maxwell RA, Smith PW, Mejia VA, Dart BW, Cofer JB, Roe SM, Burns RP. Experience with vacuum-pack temporary abdominal wound closure in 258 trauma and general and vascular surgical patients. J Am Coll Surg. 2007 May;204(5):784-92; discussion 792-3. doi: 10.1016/j.jamcollsurg.2006.12.039. Epub 2007 Mar 26.
PubMed 17481484
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vacuum-Therapy in Open Abdomen Treatment - Randomized Pilot-trial Comparing Fascial Closure and Survival With "Vacuum-Pack"-Technique vs. "Abdominal Dressing"
- ClinicalTrials.gov ID
- NCT00834314
- Acronym / sponsor ID
- ABDOVAC / 2008-291 M-MA
- Conditions
- Open Abdomen, Temporary Abdominal Closure
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: extended obligations of amended medical device law in Germany 2010 did not allow to continue and complete the trial due to budget limitation
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Universitätsmedizin MannheimUniversity, hospital or other
- Collaborators
- German Research Foundation
- Study start
- Feb 2010
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 3 Feb 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary purpose of the study is to determine whether two vacuum-wound-dressing techniques (the so called "abdominal dressing" versus "vacuum-pack-technique") are equally effective in the treatment of open abdomen.
Secondary purpose is the comparison of feasibility and economic aspects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vacuum-pack | Experimental | Procedure: Vacuum-Pack-technique for temporary abdominal closuresee Interventions |
| Abdominal dressing | Active comparator | Procedure: Abdominal-dressing-technique for temporary abdominal closuresee Interventions |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients indicated for open-abdomen-treatment by responsible consultant surgeon where vacuum-technique is judged technically possible
Key exclusion criteria (2 listed)
- Technical reasons
- unjustified risk-benefit-ratio of manipulations necessary for application of vacuum-pack-technique or abdominal-dressing-technique
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 |
|---|---|---|
| Vacuum-Pack-technique for temporary abdominal closureNegative-pressure-wound-therapy applying a method described by Brock, Barker et al 1995: "Temporary Closure of Open Abdominal Wounds - the Vacuum Pack" (see citations). | Procedure or surgery | Vacuum-pack |
| Abdominal-dressing-technique for temporary abdominal closureAlso: V.A.C.® Abdominal Dressing SystemNegative-pressure-wound-therapy for temporary abdominal closure applying a device of KCI International (V.A.C.® Abdominal Dressing System). see: http://www.kci-medical.com/kci/corporate/kcitherapies/vactherapy/dressings/abdominal/# | Procedure or surgery | Abdominal dressing |
Primary outcome
Failure of delayed abdominal fascial closure (non-prevented ventral hernia) and/or in-hospital-death of any cause (combined primary outcome)
Time frame: until end of vacuum-therapy or death
6 secondary outcomes
vacuum-therapy-related morbidity/complications
Time frame: until hospital dismissal or death
length of vacuum-therapy
Time frame: until end of vacuum-therapy or death
costs of vacuum-therapy
Time frame: until end of vacuum-therapy or death
total length of ICU-stay
Time frame: until end of ICU-therapy or death
post-dismissal health-related quality of life (SF36 and EQ-5D questionnaire)
Time frame: 12 weeks after hospital dismissal
recurrent hernia/abdominal wall dehiscence after initial facial closure during hospital stay
Time frame: 12 weeks post hospital dismissal
Results and safety
The study was stopped early (reason given: extended obligations of amended medical device law in Germany 2010 did not allow to continue and complete the trial due to budget limitation). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2015.
- Background: PubMed 7832378Brock WB, Barker DE, Burns RP. Temporary closure of open abdominal wounds: the vacuum pack. Am Surg. 1995 Jan;61(1):30-5.
- Background: PubMed 17481484Barker DE, Green JM, Maxwell RA, Smith PW, Mejia VA, Dart BW, Cofer JB, Roe SM, Burns RP. Experience with vacuum-pack temporary abdominal wound closure in 258 trauma and general and vascular surgical patients. J Am Coll Surg. 2007 May;204(5):784-92; discussion 792-3. doi: 10.1016/j.jamcollsurg.2006.12.039. Epub 2007 Mar 26.
- Description of abdominal-dressing-technique; KCI-International companyLink provided by the sponsor.
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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.
Stefan Post, Prof. Dr. principal investigator
University Medical Center Mannheim, Germany, Surgical Department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vacuum-Pack-technique for temporary abdominal closure and Abdominal-dressing-technique for temporary abdominal closure in people with Open Abdomen and Temporary Abdominal Closure, run by Universitätsmedizin Mannheim at 1 site in Germany.
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 1 inclusion and 2 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: stopped early, as of the sponsor's last update on 8 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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?
The study was stopped early (reason given: extended obligations of amended medical device law in Germany 2010 did not allow to continue and complete the trial due to budget limitation). Results are not available in the source record.
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?
Failure of delayed abdominal fascial closure (non-prevented ventral hernia) and/or in-hospital-death of any cause (combined primary outcome) (time frame: until end of vacuum-therapy or death). 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 NCT00834314, which also lists 2 linked publications.
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 8 Dec 2015.