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

Primary Purpose

Open Abdomen, Temporary Abdominal Closure, Incisional Hernia

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Vacuum Assisted Wound Closure and Permanent On-lay Mesh-mediated fascial traction (VAWCPOM)
Sponsored by
Skane University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Open Abdomen

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

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

    Arm Description

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

    Outcomes

    Primary Outcome Measures

    Incisional hernia at 1 year
    Incidence of incisional hernia after open abdomen closure with the technique

    Secondary Outcome Measures

    Fascial closure rate
    Percentage of patients possible to closed with the technique
    Complications
    Complications related to the technique
    Incisional hernia
    Incisional hernia incidence after three years
    EQ5D
    Patient reported outcome of generic quality of life
    HERO
    Patient reported outcome of abdominal wall function and discomfort

    Full Information

    First Posted
    September 10, 2022
    Last Updated
    September 30, 2022
    Sponsor
    Skane University Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05568238
    Brief Title
    Vacuum Assisted Wound Closure and Permanent On-lay Mesh-mediated Fascial Traction in Patients With Open Abdomen
    Acronym
    VAWCPOM
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 2022 (Anticipated)
    Primary Completion Date
    December 2024 (Anticipated)
    Study Completion Date
    December 2027 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Skane University Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Open Abdomen, Temporary Abdominal Closure, Incisional Hernia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    100 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Vacuum Assisted Wound Closure and Permanent On-lay Mesh-mediated fascial traction
    Arm Type
    Other
    Arm Description
    Incisional hernia incidence for patients treated with Vacuum Assisted Wound Closure and Permanent On-lay Mesh mediated fascial traction
    Intervention Type
    Procedure
    Intervention Name(s)
    Vacuum Assisted Wound Closure and Permanent On-lay Mesh-mediated fascial traction (VAWCPOM)
    Intervention Description
    Vacuum Assisted Wound Closure and Permanent On-lay Mesh-mediated fascial traction (VAWCPOM) in patients with open abdomen.
    Primary Outcome Measure Information:
    Title
    Incisional hernia at 1 year
    Description
    Incidence of incisional hernia after open abdomen closure with the technique
    Time Frame
    1 year, year 1
    Secondary Outcome Measure Information:
    Title
    Fascial closure rate
    Description
    Percentage of patients possible to closed with the technique
    Time Frame
    During hospital stay
    Title
    Complications
    Description
    Complications related to the technique
    Time Frame
    Up to 12 weeks
    Title
    Incisional hernia
    Description
    Incisional hernia incidence after three years
    Time Frame
    Through study completion, 3 years
    Title
    EQ5D
    Description
    Patient reported outcome of generic quality of life
    Time Frame
    Through study completion, 3 years
    Title
    HERO
    Description
    Patient reported outcome of abdominal wall function and discomfort
    Time Frame
    Through study completion, 3 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ulf Pettersson, Ass prof
    Phone
    +46705657446
    Email
    ulf.a.petersson@telia.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Peder Rogmark, MD, PhD
    Phone
    +46 40 333398
    Email
    peder.rogmark@skane.se
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ulf Pettersson, Ass prof
    Organizational Affiliation
    Lund University, Sweden. Department of Surgery Skane university hospital, Sweden
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    30574843
    Citation
    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.
    Results Reference
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    Vacuum Assisted Wound Closure and Permanent On-lay Mesh-mediated Fascial Traction in Patients With Open Abdomen

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