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

NCT05568238 | Not Yet Recruiting

• 1 other identifier: 131-22
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Open Abdomen; Temporary Abdominal Closure; Incisional Hernia

Outcome Measures

Primary Outcomes (1)

• Incisional hernia at 1 year

  Incidence of incisional hernia after open abdomen closure with the technique

  1 year, year 1

Secondary Outcomes (5)

• Fascial closure rate

  During hospital stay

• Complications

  Up to 12 weeks

• Incisional hernia

  Through study completion, 3 years

• EQ5D

  Through study completion, 3 years

• HERO

  Through study completion, 3 years

Study Arms (1)

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

OTHER

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)

Interventions

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

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

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Skane University Hospital: lead

Related Publications (1)

• 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 BACKGROUND

MeSH Terms

Conditions

Incisional Hernia

Interventions

Negative-Pressure Wound Therapy

Condition Hierarchy (Ancestors)

Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes

Intervention Hierarchy (Ancestors)

Drainage; Therapeutics; Surgical Procedures, Operative; Wound Closure Techniques

Study Officials

• Ulf Pettersson, Ass prof

  Lund University, Sweden. Department of Surgery Skane university hospital, Sweden

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ulf Pettersson, Ass prof

CONTACT

+46705657446; ulf.a.petersson@telia.com

Peder Rogmark, MD, PhD

CONTACT

+46 40 333398; peder.rogmark@skane.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: September 10, 2022
• First Posted: October 5, 2022
• Study Start: October 1, 2022
• Primary Completion: December 1, 2024
• Study Completion (Estimated): December 1, 2027
• Last Updated: October 5, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share