Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All comers | All comers treated with the study device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LIQUIBAND FIX8 | Device | Study device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Performance of LIQUIBAND FIX8 | 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. | From surgery to end of follow-up at 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Reoperation incidence | 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. | From surgery to end of follow-up at 12-months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
All comers for ventral incisional hernia repair at Royal Lancaster Infirmary performed by study Investigator
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal Lancaster Infirmary | Lancaster | LA1 4RP | United Kingdom |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| SSI incidence |
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. |
| From surgery to end of follow-up at 12-months |
| Chronic pain incidence | To evaluate the incidence of chronic pain following ventral incisional hernia repair i.e. beyond 3 months surgery | From surgery to end of follow-up at 12-months |
| Adverse Events | 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. | From surgery to end of follow-up at 12-months |