Open AbdomenVAWCPOMNCT05568238
Vacuum Assisted Wound Closure and Permanent On-lay Mesh-mediated Fascial Traction in Patients With Open Abdomen
A study testing Vacuum Assisted Wound Closure and Permanent On-lay Mesh-mediated fascial traction (VAWCPOM) in people with Open Abdomen and Temporary Abdominal Closure, run by Skane University Hospital.
Trial summary
Open abdomen therapy is used in trauma and non-trauma patients where the abdomen is not possible to close, or the intraabdominal conditions is not suitable for closure. In 2007, a new technique that made use of negative pressure wound therapy and mesh-mediated fascial traction for closure of the open abdomen was… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Open Abdomen, Temporary Abdominal Closure, Incisional Hernia
- What is being tested?
- Vacuum Assisted Wound Closure and Permanent On-lay Mesh-mediated fascial traction (VAWCPOM)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Oct 2022to Dec 2027
- Phase
- Interventional
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
- All patients ≥18 years old treated with an open abdomen with a midline incision, regardless of indication.
Who cannot join
- Patient declining participation
- Existing incisional hernia or primary ventral hernia ≥3 cm
- Existing mesh in the abdominal wall, located in the midline and irrespective of mesh size
- Existing ostomy/parastomal hernia located in a position that prevents the VAWCPOM technique to be utilized
- Closure of the abdomen at first dressing change, e. g. without mesh traction
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Vacuum Assisted Wound Closure and Permanent On-lay Mesh-mediated Fascial Traction (VAWCPOM) in Patients With Open Abdomen - a Prospective Multi-center Cohort Study
Open abdomen therapy is used in trauma and non-trauma patients where the abdomen is not possible to close, or the intraabdominal conditions is not suitable for closure. In 2007, a new technique that made use of negative pressure wound therapy and mesh-mediated fascial traction for closure of the open abdomen was described from the Department of Surgery in Malmö, Sweden. With this new technique, fascial closure rates were high but long-term incisional hernia formation was seen in approximately half of the patients alive after five years. To overcome the high incisional hernia incidence, a new technique utilizing a permanent on-lay mesh for traction and reinforcement of the incision at fascial closure was developed.
Hypothesis Lower incisional hernia rates in comparison with literature reported results of other techniques for open abdomen treatment, with similar complication rates.
Read more
Aims To evaluate early and late clinical outcome of the novel vacuum-assisted wound closure and permanent on-lay mesh-mediated fascial traction technique.
Design A prospective six-center cohort study in Sweden and Denmark. Study inclusion during a two-year period or longer to include at least 100 patients. Statistical analysis will be done by intention-to-treat and as sub-group per-protocol analysis.
- Conditions
- Open Abdomen, Temporary Abdominal Closure, Incisional Hernia
- Being tested
- Vacuum Assisted Wound Closure and Permanent On-lay Mesh-mediated fascial traction (VAWCPOM)
- Medical subject headings
- Incisional Hernia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vacuum Assisted Wound Closure and Permanent On-lay Mesh-mediated fascial traction (VAWCPOM)Procedure or surgery
Vacuum Assisted Wound Closure and Permanent On-lay Mesh-mediated fascial traction (VAWCPOM) in patients with open abdomen.
| Study group | Role | What they receive |
|---|---|---|
| Vacuum Assisted Wound Closure and Permanent On-lay Mesh-mediated fascial traction | Other | Incisional hernia incidence for patients treated with Vacuum Assisted Wound Closure and Permanent On-lay Mesh mediated fascial traction Receives: Procedure: Vacuum Assisted Wound Closure and Permanent On-lay Mesh-mediated fascial traction (VAWCPOM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incisional hernia at 1 year
Incidence of incisional hernia after open abdomen closure with the technique
Measured: 1 year, year 1
Secondary outcomes (5)
Fascial closure rate
Percentage of patients possible to closed with the technique
Measured: During hospital stay
Complications
Complications related to the technique
Measured: Up to 12 weeks
Incisional hernia
Incisional hernia incidence after three years
Measured: Through study completion, 3 years
EQ5D
Patient reported outcome of generic quality of life
Measured: Through study completion, 3 years
HERO
Patient reported outcome of abdominal wall function and discomfort
Measured: Through study completion, 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2022
- Study startOct 2022 (estimated)
- Primary completionDec 2024 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Skane University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ulf Petersson, Skane University Hospital
- Investigators
- Ulf Pettersson, Ass prof, Principal investigator, Lund University, Sweden. Department of Surgery Skane university hospital, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05568238
- Sponsor's protocol ID
- 131-22
- Acronym
- VAWCPOM
- Status last verified
- Sep 2022
- First submitted
- 10 Sep 2022
- Last updated
- 5 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Petersson P, Montgomery A, Petersson U. Vacuum-Assisted Wound Closure and Permanent Onlay Mesh-Mediated Fascial Traction: A Novel Technique for the Prevention of Incisional Hernia after Open Abdomen Therapy Including Results From a Retrospective Case Series. Scand J Surg. 2019 Sep;108(3):216-226. doi: 10.1177/1457496918818979. Epub 2018 Dec 21.
PubMed 30574843