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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05568238
Other study ID # 131-22
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date October 2022
Est. completion date December 2027

Study information

Verified date September 2022
Source Skane University Hospital
Contact Ulf Pettersson, Ass prof
Phone +46705657446
Email ulf.a.petersson@telia.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 100
Est. completion date December 2027
Est. primary completion date December 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Skane University Hospital

References & 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Incisional hernia at 1 year Incidence of incisional hernia after open abdomen closure with the technique 1 year, year 1
Secondary Fascial closure rate Percentage of patients possible to closed with the technique During hospital stay
Secondary Complications Complications related to the technique Up to 12 weeks
Secondary Incisional hernia Incisional hernia incidence after three years Through study completion, 3 years
Secondary EQ5D Patient reported outcome of generic quality of life Through study completion, 3 years
Secondary HERO Patient reported outcome of abdominal wall function and discomfort Through study completion, 3 years
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