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
About this trial
This is an interventional treatment trial for Open Abdomen
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
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
NCT ID
NCT05568238
First Posted
September 10, 2022
Last Updated
September 30, 2022
Sponsor
Skane University Hospital
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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