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

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.

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Incisional Hernia; Open Abdomen; Temporary Abdominal Closure
• Intervention / Treatment: Procedure: Vacuum Assisted Wound Closure and Permanent On-lay Mesh-mediated fascial traction (VAWCPOM)

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ulf Pettersson, Ass prof; Phone Number: +46705657446; Email: ulf.a.petersson@telia.com
• Study Contact Backup: Name: Peder Rogmark, MD, PhD; Phone Number: +46 40 333398; Email: peder.rogmark@skane.se

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Vacuum Assisted Wound Closure and Permanent On-lay Mesh-mediated fascial traction; 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); Vacuum Assisted Wound Closure and Permanent On-lay Mesh-mediated fascial traction (VAWCPOM) in patients with open abdomen.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Skane University Hospital
• Investigators: Principal Investigator: Ulf Pettersson, Ass prof, Lund University, Sweden. Department of Surgery Skane university hospital, Sweden

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): October 1, 2022
• Primary Completion (Anticipated): December 1, 2024
• Study Completion (Anticipated): December 1, 2027

Study Registration Dates

• First Submitted: September 10, 2022
• First Submitted That Met QC Criteria: September 30, 2022
• First Posted (Actual): October 5, 2022

Study Record Updates

• Last Update Posted (Actual): October 5, 2022
• Last Update Submitted That Met QC Criteria: September 30, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pathological Conditions, Anatomical; Hernia; Incisional Hernia
• Other Study ID Numbers: 131-22

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No