Hernia Incisional Ventral
Conditions
Brief summary
This study is designed to evaluate the safety and performance of device LiquiBand FIX8 Open hernia mesh fixation device. The use of this device is not experimental, as it is already approved for use in the EU (CE-marked). This is a retrospective post market clinical follow-up study to collect information about the use of the device in a real-world setting for ventral incisional hernia repair. Ventral incisional hernias occur following surgery and the most common method of treatment includes implanting a mesh, which in the case of ventral incisional hernia, the standard of care is intra-peritoneal onlay mesh. This is fixed in place using sutures, tacks or adhesive. The LiquiBand FIX8 Open device is an atraumatic device specifically engineered for strong mesh fixation of hernia repair meshes. Hernia repair meshes are woven sheets of flexible synthetic plastic which are placed tension-free over the weakness in the peritoneum abdominal wall, essentially 'plugging' it up. Tension is created in the abdominal wall during repair, but the mesh allows this tension to be spread out. The mesh must be secured to the underlying tissue and this is often done with the use of tacks or sutures, however, the study device instead uses a glue (N-Butyl 2 cyanoacrylate adhesive) to secure the mesh. The FIX8 Open device is designed for the application of this glue to the implanted hernia repair mesh in order to fix the mesh to the underlying tissue. When the glue is applied to the mesh and tissue, it polymerises (forms a chemical bond) due to the moisture on the tissue surface within approximately 10 seconds and allows the mesh to remain in the correct position. The study device can also be used to close topical wounds (the opening that the surgeon makes on the surface to access the hernia).
Interventions
DEVICELIQUIBAND FIX8
Study device
Sponsors
Advanced Medical Solutions Ltd.
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Patient is ≥ 18 years of age and ≤ 80 years of age. * Patient had a ventral incisional hernia (this may include both primary and recurrent). * Patient underwent a ventral incisional repair and LIQUIBAND FIX8® adhesive was used for mesh fixation (including those patients where supplemental fixation was used) * Has a minimum of 12 months follow-up.
Exclusion criteria
* Concomitant parastomal hernia repair * No other exclusions specific to the device
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Performance of LIQUIBAND FIX8 | From surgery to end of follow-up at 12 months | The performance of LIQUIBAND FIX8® adhesive when used as a method of mesh fixation (independently or in conjunction with another mesh fixation device) during ventral incisional hernia, through reported hernia recurrence rates at 12 months post-surgery. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Reoperation incidence | From surgery to end of follow-up at 12-months | To evaluate the incidence of reoperation following ventral incisional hernia repair using LIQUIBAND FIX8 as the method of mesh fixation (independently or in conjunction with another mesh fixation device) at discharge, 6-12 weeks follow up and 12 months post-surgery. |
| SSI incidence | From surgery to end of follow-up at 12-months | To evaluate the incidence of surgical site infection following ventral incisional hernia repair using LIQUIBAND FIX8 as the method of mesh fixation (independently or in conjunction with another mesh fixation device) at discharge, 6-12 weeks follow up and 12 months post-surgery. |
| Chronic pain incidence | From surgery to end of follow-up at 12-months | To evaluate the incidence of chronic pain following ventral incisional hernia repair i.e. beyond 3 months surgery |
| Adverse Events | From surgery to end of follow-up at 12-months | To assess post market safety through the reporting of adverse events following ventral incisional hernia repair using LIQUIBAND FIX8 as the method of mesh fixation (independently or in conjunction with another mesh fixation device) at discharge, 6-12 weeks follow up and 12 months post-surgery. |
Countries
United Kingdom
Outcome results
None listed