Incisional Hernia, Open Abdomen, Temporary Abdominal Closure
Conditions
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.
Interventions
PROCEDUREVacuum 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.
Sponsors
Skane University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incisional hernia at 1 year | 1 year, year 1 | Incidence of incisional hernia after open abdomen closure with the technique |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fascial closure rate | During hospital stay | Percentage of patients possible to closed with the technique |
| Complications | Up to 12 weeks | Complications related to the technique |
| Incisional hernia | Through study completion, 3 years | Incisional hernia incidence after three years |
| EQ5D | Through study completion, 3 years | Patient reported outcome of generic quality of life |
| HERO | Through study completion, 3 years | Patient reported outcome of abdominal wall function and discomfort |
Contacts
Primary ContactUlf Pettersson, Ass prof
Backup ContactPeder Rogmark, MD, PhD
Outcome results
None listed