Clinical trial NCT05568238: Vacuum Assisted Wound Closure and Permanent On-lay Mesh-mediated Fascial Traction in Patients With Open Abdomen
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
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Open Abdomen
Temporary Abdominal Closure
Incisional Hernia
Lead sponsor: Skane University Hospital
Sponsor class: OTHER
First posted: 2022-10-05
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Incisional hernia at 1 year
timeFrame: 1 year, year 1
Secondary outcomes:
measure: Fascial closure rate
timeFrame: During hospital stay
measure: Complications
timeFrame: Up to 12 weeks
measure: Incisional hernia
timeFrame: Through study completion, 3 years
measure: EQ5D
timeFrame: Through study completion, 3 years
measure: HERO
timeFrame: Through study completion, 3 years
Other outcomes:
Locations:
Study officials:
affiliation: Lund University, Sweden. Department of Surgery Skane university hospital, Sweden
name: Ulf Pettersson, Ass prof
role: PRINCIPAL_INVESTIGATOR
References:
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.