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

Study Overview
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Brief Summary
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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.

Official Title
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Vacuum Assisted Wound Closure and Permanent On-lay Mesh-mediated Fascial Traction (VAWCPOM) in Patients With Open Abdomen - a Prospective Multi-center Cohort Study

Conditions
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Open Abdomen, Temporary Abdominal Closure, Incisional Hernia

Intervention / Treatment
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* Procedure: Vacuum Assisted Wound Closure and Permanent On-lay Mesh-mediated fascial traction (VAWCPOM)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Vacuum Assisted Wound Closure and Permanent On-lay Mesh-mediated fascial traction<br>Incisional hernia incidence for patients treated with Vacuum Assisted Wound Closure and Permanent On-lay Mesh mediated fascial traction | Procedure: Vacuum Assisted Wound Closure and Permanent On-lay Mesh-mediated fascial traction (VAWCPOM)<br>* Vacuum Assisted Wound Closure and Permanent On-lay Mesh-mediated fascial traction (VAWCPOM) in patients with open abdomen.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incisional hernia at 1 year | Incidence of incisional hernia after open abdomen closure with the technique | 1 year, year 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fascial closure rate | Percentage of patients possible to closed with the technique | During hospital stay | 
| Complications | Complications related to the technique | Up to 12 weeks | 
| Incisional hernia | Incisional hernia incidence after three years | Through study completion, 3 years | 
| EQ5D | Patient reported outcome of generic quality of life | Through study completion, 3 years | 
| HERO | Patient reported outcome of abdominal wall function and discomfort | Through study completion, 3 years |