About this trial
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
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
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
Trial design
Single group
Treatments tested in this trial
Vacuum Assisted Wound Closure and Permanent On-lay Mesh-mediated fascial traction (VAWCPOM)
Procedure/SurgeryVacuum Assisted Wound Closure and Permanent On-lay Mesh-mediated fascial traction (VAWCPOM) in patients with open abdomen.
Treatment groups
Trial outcomes
Primary outcomes
Incisional hernia at 1 year
Incidence of incisional hernia after open abdomen closure with the technique
Secondary outcomes
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
Locations
Sponsors and contacts
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