LIQUIBAND FIX8® for Ventral Incisional Hernia (LBF8-03)

Advanced Medical Solutions

Status

Not yet enrolling

Conditions

Hernia Incisional Ventral

Treatments

Device: LIQUIBAND FIX8

Study type

Observational

Funder types

Industry

Identifiers

NCT07295379

LBF8-03

Details and patient eligibility

About

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).

Enrollment

148 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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

Every patient who required a ventral incisional hernia repair without concomitant parastomal hernia repair that meets the eligibility criteria will be included in this study. There will be no exclusions specific to the device. Any exclusions relating to device labelling, will have been established as part of the patient's standard of care, prior to the surgical procedure.