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Not yet recruiting NCT05568238

Vacuum Assisted Wound Closure and Permanent On-lay Mesh-mediated Fascial Traction in Patients With Open Abdomen

No phase Interventional Open Abdomen Temporary Abdominal Closure Incisional Hernia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Vacuum Assisted Wound Closure and Permanent On-lay Mesh-mediated fascial traction (VAWCPOM).
Who it may be relevant to
Registry conditions: Open Abdomen, Temporary Abdominal Closure, Incisional Hernia. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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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

Overview

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. 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.

Interventions

  • Procedure Vacuum Assisted Wound Closure and Permanent On-lay Mesh-mediated fascial traction (VAWCPOM)
    Vacuum Assisted Wound Closure and Permanent On-lay Mesh-mediated fascial traction (VAWCPOM) in patients with open abdomen.

Primary outcome measures

  • Incisional hernia at 1 year [Time frame: 1 year, year 1]
Secondary outcome measures (5)
  • Fascial closure rate [Time frame: During hospital stay]
  • Complications [Time frame: Up to 12 weeks]
  • Incisional hernia [Time frame: Through study completion, 3 years]
  • EQ5D [Time frame: Through study completion, 3 years]
  • HERO [Time frame: Through study completion, 3 years]

Eligibility criteria

Inclusion criteria

  • All patients ≥18 years old treated with an open abdomen with a midline incision, regardless of indication.

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

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. PMID 30574843

Identifiers

NCT: NCT05568238 · 131-22

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗