Incisional Hernia Clinical Trial
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
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.
n/a
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT06016426 -
Mass Closure vs Layer by Layer Closure
|
N/A | |
| Recruiting |
NCT05734222 -
Optimization of Surgical Treatment of Patients With Incisional Ventral Hernias
|
N/A | |
| Enrolling by invitation |
NCT03105895 -
Prevention of Incisional Hernia With an Onlay Mesh Visible on MRI
|
N/A | |
| Completed |
NCT02089958 -
Standardization of Laparoscopic Hernia Repair
|
N/A | |
| Completed |
NCT01961687 -
A Prospective, Multi-Center Study of Phasix™ Mesh for Ventral or Incisional Hernia Repair.
|
N/A | |
| Completed |
NCT00998907 -
PDS*Plus and Wound Infections After Laparotomy
|
N/A | |
| Terminated |
NCT00498810 -
COMplete Versus PArtial Open inCisional Hernia Repair (COMPAC-TRIAL)
|
N/A | |
| Completed |
NCT04961346 -
RCT Comparing Lightweight vs. Heavyweight Meshes in Incisional Hernia Repair
|
N/A | |
| Terminated |
NCT03912662 -
ProGripTM Self-Gripping Polyester Mesh in Incisional Hernia Prevention
|
N/A | |
| Recruiting |
NCT05620121 -
ACute Treatment of Incisional Ventral Hernia
|
||
| Recruiting |
NCT03561727 -
Risk Factors for Development of Incisional Hernia in Transverse Incisions
|
N/A | |
| Completed |
NCT03938688 -
Randomized Control Trial Comparing Transfascial Suture for Mesh Fixation to No Mesh Fixation
|
N/A | |
| Not yet recruiting |
NCT02896686 -
Efficacy of an Onlay Mesh for Prevention of Incisional Hernia After Loop Ileostomy Closure
|
Phase 4 | |
| Recruiting |
NCT02277262 -
PROPHYlactic Implantation of BIOlogic Mesh in Peritonitis (PROPHYBIOM)
|
Phase 4 | |
| Active, not recruiting |
NCT02328352 -
"BP as a New Device for Surgery and Solid Cancer and Hematopoietic System Tumors Treatment. Effects of BP Implantation"
|
Phase 1/Phase 2 | |
| Suspended |
NCT01520168 -
Composix Kugel Mesh Recall Leaves Unresolved Problems of Patient Management
|
N/A | |
| Completed |
NCT05579652 -
Change in Fascial Tension in Open Abdomens
|
||
| Active, not recruiting |
NCT03390764 -
Hernia After Colorectal Cancer Surgery
|
N/A | |
| Completed |
NCT02321059 -
Validation of the Goodstrength System for Assessment of Abdominal Wall Strength in Patients With Incisional Hernia
|
N/A | |
| Completed |
NCT02011048 -
Giant Ventral Incisional Hernia: Abdominal Wall Function, Respiratory Performance and Quality of Life
|
N/A |