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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

Tracking Information
First Submitted Date  ICMJE September 10, 2022
First Posted Date  ICMJE October 5, 2022
Last Update Posted Date October 5, 2022
Estimated Study Start Date  ICMJE October 2022
Estimated Primary Completion Date December 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 30, 2022)		 Incisional hernia at 1 year [ Time Frame: 1 year, year 1 ]
Incidence of incisional hernia after open abdomen closure with the technique
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: September 30, 2022)
  • Fascial closure rate [ Time Frame: During hospital stay ]
    Percentage of patients possible to closed with the technique
  • Complications [ Time Frame: Up to 12 weeks ]
    Complications related to the technique
  • Incisional hernia [ Time Frame: Through study completion, 3 years ]
    Incisional hernia incidence after three years
  • EQ5D [ Time Frame: Through study completion, 3 years ]
    Patient reported outcome of generic quality of life
  • HERO [ Time Frame: Through study completion, 3 years ]
    Patient reported outcome of abdominal wall function and discomfort
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Vacuum Assisted Wound Closure and Permanent On-lay Mesh-mediated Fascial Traction in Patients With Open Abdomen
Official Title  ICMJE Vacuum Assisted Wound Closure and Permanent On-lay Mesh-mediated Fascial Traction (VAWCPOM) in Patients With Open Abdomen - a Prospective Multi-center Cohort Study
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Open Abdomen
  • Temporary Abdominal Closure
  • Incisional Hernia
Intervention  ICMJE 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.
Study Arms  ICMJE 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
Intervention: Procedure: Vacuum Assisted Wound Closure and Permanent On-lay Mesh-mediated fascial traction (VAWCPOM)
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: September 30, 2022)		 100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2027
Estimated Primary Completion Date December 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Ulf Pettersson, Ass prof +46705657446 ulf.a.petersson@telia.com
Contact: Peder Rogmark, MD, PhD +46 40 333398 peder.rogmark@skane.se
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05568238
Other Study ID Numbers  ICMJE 131-22
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Ulf Petersson, Skane University Hospital
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Skane University Hospital
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Ulf Pettersson, Ass prof Lund University, Sweden. Department of Surgery Skane university hospital, Sweden
PRS Account Skane University Hospital
Verification Date September 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP