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

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ClinicalTrials.gov Identifier: NCT05568238
Recruitment Status : Not yet recruiting
First Posted : October 5, 2022
Last Update Posted : October 5, 2022
Sponsor:
Information provided by (Responsible Party):
Ulf Petersson, Skane University Hospital

Study Description
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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.


Condition or disease Intervention/treatment Phase
Open Abdomen Temporary Abdominal Closure Incisional Hernia Procedure: Vacuum Assisted Wound Closure and Permanent On-lay Mesh-mediated fascial traction (VAWCPOM) Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Vacuum Assisted Wound Closure and Permanent On-lay Mesh-mediated Fascial Traction (VAWCPOM) in Patients With Open Abdomen - a Prospective Multi-center Cohort Study
Estimated Study Start Date : October 2022
Estimated Primary Completion Date : December 2024
Estimated Study Completion Date : December 2027

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. Incisional hernia at 1 year [ Time Frame: 1 year, year 1 ]
    Incidence of incisional hernia after open abdomen closure with the technique


Secondary Outcome Measures :
  1. Fascial closure rate [ Time Frame: During hospital stay ]
    Percentage of patients possible to closed with the technique

  2. Complications [ Time Frame: Up to 12 weeks ]
    Complications related to the technique

  3. Incisional hernia [ Time Frame: Through study completion, 3 years ]
    Incisional hernia incidence after three years

  4. EQ5D [ Time Frame: Through study completion, 3 years ]
    Patient reported outcome of generic quality of life

  5. HERO [ Time Frame: Through study completion, 3 years ]
    Patient reported outcome of abdominal wall function and discomfort


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05568238


Contacts
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Contact: Ulf Pettersson, Ass prof +46705657446 ulf.a.petersson@telia.com
Contact: Peder Rogmark, MD, PhD +46 40 333398 peder.rogmark@skane.se

Sponsors and Collaborators
Skane University Hospital
Investigators
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Principal Investigator: Ulf Pettersson, Ass prof Lund University, Sweden. Department of Surgery Skane university hospital, Sweden
More Information
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Publications:

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Responsible Party: Ulf Petersson, Principal investigator, Skane University Hospital
ClinicalTrials.gov Identifier: NCT05568238    
Other Study ID Numbers: 131-22
First Posted: October 5, 2022    Key Record Dates
Last Update Posted: October 5, 2022
Last Verified: September 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Incisional Hernia
Hernia
Pathological Conditions, Anatomical
Postoperative Complications
Pathologic Processes