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

Skane University Hospital

Status: Not yet enrolling

Conditions: Open Abdomen; Incisional Hernia; Temporary Abdominal Closure

Treatments: Procedure: Vacuum Assisted Wound Closure and Permanent On-lay Mesh-mediated fascial traction (VAWCPOM)

Study type: Interventional

Funder types: Other

Identifiers

NCT05568238

131-22

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

Vacuum Assisted Wound Closure and Permanent On-lay Mesh-mediated fascial traction

Other group

Description:

Incisional hernia incidence for patients treated with Vacuum Assisted Wound Closure and Permanent On-lay Mesh mediated fascial traction

Treatment:

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