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

Not Applicable

Not yet recruiting

• Conditions: Open Abdomen; Temporary Abdominal Closure; Incisional Hernia
• Interventions: Procedure: Vacuum Assisted Wound Closure and Permanent On-lay Mesh-mediated fascial traction (VAWCPOM)

• Registration Number: NCT05568238
• Lead Sponsor: Skane University Hospital

Brief 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 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-09
• Study First Submitted: 2022-09-10
• Study First Submitted QC: 2022-09-30
• Last Update Submitted: 2022-09-30
• Study Start: 2022-10
• Study First Posted: 2022-10-05
• Last Update Posted: 2022-10-05
• Primary Completion: 2024-12
• Study Completion: 2027-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Vacuum Assisted Wound Closure and Permanent On-lay Mesh-mediated fascial traction	Vacuum Assisted Wound Closure and Permanent On-lay Mesh-mediated fascial traction (VAWCPOM)	Incisional hernia incidence for patients treated with Vacuum Assisted Wound Closure and Permanent On-lay Mesh mediated fascial traction

Primary Outcome Measures

Name	Time	Method
Incisional hernia at 1 year	1 year, year 1	Incidence of incisional hernia after open abdomen closure with the technique

Secondary Outcome Measures

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