Open AbdomenNCT00494793
Vacuum Assisted Wound Closure (VAWC) and Mesh Mediated Fascial Traction
A study testing VAWC and mesh mediated fascial traction in people with Open Abdomen and Fascial Closure, run by Skane University Hospital at 5 sites in Sweden.
Trial summary
The purpose of this multicenter trial is to prospectively evaluate a novel combination of vacuum assisted wound closure (VAWC) and mesh mediated fascial traction for closure of open abdomens. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Open Abdomen, Fascial Closure
- What is being tested?
- VAWC and mesh mediated fascial traction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 111 participants
- Where
- 5 sitesSweden
- Study dates
- 1 Apr 2006to 1 Apr 2015
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- open abdomen patients with midline incisions, where vacuum assisted wound closure system and mesh mediated fascial traction is applicable
Who cannot join
- open abdomen patients treated otherwise
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Sweden5 sites
Department of Surgery, Falu Hospital
Falun, 791 82
Department of Surgery, Gävle Hospital
Gävle, 801 87
Department of Surgery, Malmö University Hospital
Malmö, 205 02
Department of Vascular Surgery, Malmö University Hospital
Malmö, 205 02
Department of Surgery, Uppsala University Hospital
Uppsala, 751 85
About this study
Official title: Vacuum Assisted Wound Closure (VAWC) and Mesh Mediated Fascial Traction - Prospective Study of a Novel Technique for Open Abdomen Closure
The purpose of this multicenter trial is to prospectively evaluate a novel combination of vacuum assisted wound closure (VAWC) and mesh mediated fascial traction for closure of open abdomens.
Read the detailed description
Open abdomen treatment often results in difficulties in closing the abdomen. Highest closure rates are seen with the vacuum assisted wound closure (VAWC) technique. Failures with this technique is occasionally experienced, especially in cases with severe visceral swelling needing longer treatment periods with open abdomen. A novel combination of vacuum assisted wound closure and mesh mediated fascial traction for managing the open abdomen was therefore developed and initially tested in a small pilot-like study with encouraging results with late primary closure of the abdomens in all seven patients.
In this multicenter study we prospectively evaluate the technique.
Inclusion criteria:
All patients treated with open abdomen at the 4 participating hospitals are registered, and only those patients who have commenced therapy with VAWC and mesh mediated fascial traction will be included in the study in an intention to treat model.
Exclusion criteria:
Treatment of open abdomen with other techniques.
Method:
- The first period of 2-5 days only the abdominal VAWC dressing is applied.
- On day 3-10 a polypropylene mesh is sutured to the fascial edges, between the two layers of the VAWC system, and tightened.
- The VAWC dressing is changed and the mesh tightened every 2-3 days, resulting in gradual approximation of the fascial edges.
- Finally the mesh is removed and the fascia is closed.
- At closure the wound to suture length is registered.
Primary endpoint:
Frequency of primary fascial closure.
Secondary endpoints:
- study of factors associated with failure of fascial closure and in-hospital mortality,
- abdominal pressure variation attributable to the use of the technique,
- duration of treatment with open abdomen,
- frequency of incisional hernia after one and five years.
Duration of the study:
3-5 years. Enrollment of open abdomen cases.
Follow-up schedule for patients:
- Clinical evaluation at 1 and 5 years.
- CT-examination at 1 year.
- Conditions
- Open Abdomen, Fascial Closure
- Being tested
- VAWC and mesh mediated fascial traction
- Keywords
- Open abdomen, Fascial closure, Vacuum assisted wound closure, Mesh, Abdominal compartment syndrome, Intraabdominal pressure, Incisional hernia
- Medical subject headings
- Intra-Abdominal Hypertension, Incisional Hernia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VAWC and mesh mediated fascial tractionProcedure or surgery
The first period of 2-5 days only the abdominal VAWC dressing is applied. On day 3-10 a polypropylene mesh is sutured to the fascial edges, between the two layers of the VAWC system, and tightened.
The VAWC dressing is changed and the mesh tightened every 2-3 days, resulting in gradual approximation of the fascial edges.
Finally the mesh is removed and the fascia is closed
| Study group | Role | What they receive |
|---|---|---|
| VAWC and mesh mediated fascial traction | Other | This is a study aiming to evaluate one technique for temporary abdominal closure for open abdomen therapy in all patients applicable according to the inclusion criteria Receives: Procedure: VAWC and mesh mediated fascial traction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary fascial closure rate
Primary fascial closure rate with the technique
Measured: 2 months
Secondary outcomes (1)
Factors associated with failure of fascial closure and in-hospital mortality, abdominal pressure, duration of treatment with open abdomen, frequency of incisional hernia development
Early, intermediate and late outcomes
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2007 (estimated)
- Study start1 Apr 2006
- Primary completion31 Aug 2009
- Study completion1 Apr 2015
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- Skane University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Uppsala University Hospital, Gävle Hospital, Falu Hospital, KCI Europe Holding B.V., The Swedish Research Council
- Responsible party
- Principal investigator, Ulf Petersson, Skane University Hospital
- Investigators
- Ulf Petersson, MD, PhD, Principal investigator, Department of Surgery, Malmö University Hospital, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00494793
- Sponsor's protocol ID
- EPNLund 564/2005
- Status last verified
- Dec 2017
- First submitted
- 29 Jun 2007
- Last updated
- 29 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Bjarnason T, Montgomery A, Ekberg O, Acosta S, Svensson M, Wanhainen A, Bjorck M, Petersson U. One-year follow-up after open abdomen therapy with vacuum-assisted wound closure and mesh-mediated fascial traction. World J Surg. 2013 Sep;37(9):2031-8. doi: 10.1007/s00268-013-2082-x.
PubMed 23703638Sorelius K, Wanhainen A, Acosta S, Svensson M, Djavani-Gidlund K, Bjorck M. Open abdomen treatment after aortic aneurysm repair with vacuum-assisted wound closure and mesh-mediated fascial traction. Eur J Vasc Endovasc Surg. 2013 Jun;45(6):588-94. doi: 10.1016/j.ejvs.2013.01.041. Epub 2013 Mar 1.
PubMed 23465456
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vacuum Assisted Wound Closure (VAWC) and Mesh Mediated Fascial Traction - Prospective Study of a Novel Technique for Open Abdomen Closure
- ClinicalTrials.gov ID
- NCT00494793
- Acronym / sponsor ID
- EPNLund 564/2005
- Conditions
- Open Abdomen, Fascial Closure
- Keywords
- Open abdomen, Fascial closure, Vacuum assisted wound closure, Mesh, Abdominal compartment syndrome, Intraabdominal pressure, Incisional hernia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- Skane University HospitalUniversity, hospital or other
- Collaborators
- Uppsala University Hospital, Gävle Hospital, Falu Hospital, KCI Europe Holding B.V., The Swedish Research Council
- Study start
- 1 Apr 2006 (actual)
- Primary completion
- 31 Aug 2009 (actual)
- Study completion
- 1 Apr 2015 (actual)
- First posted
- 2 Jul 2007 (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 purpose of this multicenter trial is to prospectively evaluate a novel combination of vacuum assisted wound closure (VAWC) and mesh mediated fascial traction for closure of open abdomens.
Detailed description
Open abdomen treatment often results in difficulties in closing the abdomen. Highest closure rates are seen with the vacuum assisted wound closure (VAWC) technique. Failures with this technique is occasionally experienced, especially in cases with severe visceral swelling needing longer treatment periods with open abdomen. A novel combination of vacuum assisted wound closure and mesh mediated fascial traction for managing the open abdomen was therefore developed and initially tested in a small pilot-like study with encouraging results with late primary closure of the abdomens in all seven patients.
In this multicenter study we prospectively evaluate the technique.
Inclusion criteria:
All patients treated with open abdomen at the 4 participating hospitals are registered, and only those patients who have commenced therapy with VAWC and mesh mediated fascial traction will be included in the study in an intention to treat model.
Exclusion criteria:
Treatment of open abdomen with other techniques.
Method:
- The first period of 2-5 days only the abdominal VAWC dressing is applied.
- On day 3-10 a polypropylene mesh is sutured to the fascial edges, between the two layers of the VAWC system, and tightened.
- The VAWC dressing is changed and the mesh tightened every 2-3 days, resulting in gradual approximation of the fascial edges.
- Finally the mesh is removed and the fascia is closed.
- At closure the wound to suture length is registered.
Primary endpoint:
Frequency of primary fascial closure.
Secondary endpoints:
- study of factors associated with failure of fascial closure and in-hospital mortality,
- abdominal pressure variation attributable to the use of the technique,
- duration of treatment with open abdomen,
- frequency of incisional hernia after one and five years.
Duration of the study:
3-5 years. Enrollment of open abdomen cases.
Follow-up schedule for patients:
- Clinical evaluation at 1 and 5 years.
- CT-examination at 1 year.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| VAWC and mesh mediated fascial traction | Other | Procedure: VAWC and mesh mediated fascial tractionThis is a study aiming to evaluate one technique for temporary abdominal closure for open abdomen therapy in all patients applicable according to the inclusion criteria |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- open abdomen patients with midline incisions, where vacuum assisted wound closure system and mesh mediated fascial traction is applicable
Key exclusion criteria (1 listed)
- open abdomen patients treated otherwise
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 |
|---|---|---|
| VAWC and mesh mediated fascial tractionThe first period of 2-5 days only the abdominal VAWC dressing is applied. On day 3-10 a polypropylene mesh is sutured to the fascial edges, between the two layers of the VAWC system, and tightened. The VAWC dressing is changed and the mesh tightened every 2-3 days, resulting in gradual approximation of the fascial edges. Finally the mesh is removed and the fascia is closed | Procedure or surgery | VAWC and mesh mediated fascial traction |
Primary outcome
Primary fascial closure rate
Time frame: 2 months
Primary fascial closure rate with the technique
1 secondary outcome
Factors associated with failure of fascial closure and in-hospital mortality, abdominal pressure, duration of treatment with open abdomen, frequency of incisional hernia development
Time frame: 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2017.
- Derived from this study: PubMed 23703638Bjarnason T, Montgomery A, Ekberg O, Acosta S, Svensson M, Wanhainen A, Bjorck M, Petersson U. One-year follow-up after open abdomen therapy with vacuum-assisted wound closure and mesh-mediated fascial traction. World J Surg. 2013 Sep;37(9):2031-8. doi: 10.1007/s00268-013-2082-x.
- Derived from this study: PubMed 23465456Sorelius K, Wanhainen A, Acosta S, Svensson M, Djavani-Gidlund K, Bjorck M. Open abdomen treatment after aortic aneurysm repair with vacuum-assisted wound closure and mesh-mediated fascial traction. Eur J Vasc Endovasc Surg. 2013 Jun;45(6):588-94. doi: 10.1016/j.ejvs.2013.01.041. Epub 2013 Mar 1.
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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.
Ulf Petersson, MD, PhD principal investigator
Department of Surgery, Malmö University Hospital, Sweden
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VAWC and mesh mediated fascial traction in people with Open Abdomen and Fascial Closure, run by Skane University Hospital at 5 sites in Sweden.
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 1 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 29 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Sweden. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Primary fascial closure rate (time frame: 2 months). 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 NCT00494793, 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 29 Dec 2017.