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

A Retrospective, Single Centre, Observational Study to Evaluate the Safety and Effectiveness of LIQUIBAND FIX8® When Used for Mesh Fixation During Ventral Incisional Hernia Repair.

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).

Study Overview

• Status: Not yet recruiting
• Conditions: Hernia Incisional Ventral
• Intervention / Treatment: Device: LIQUIBAND FIX8

• Study Type: Observational
• Enrollment (Estimated): 148

Contacts and Locations

• Study Contact: Name: Charlotte Moss; Phone Number: +44 (0) 7918915377; Email: charlotte.moss@admedsol.com

Study Locations

• United Kingdom
  • Lancaster, United Kingdom, LA1 4RP
    • Royal Lancaster Infirmary
    • Contact: Paul Wilson; Phone Number: 01524 49396; Email: Paul.wilson@mbht.nhs.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

All comers for ventral incisional hernia repair at Royal Lancaster Infirmary performed by study Investigator

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
All comers; All comers treated with the study device	Device: LIQUIBAND FIX8; Study device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: Advanced Medical Solutions Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): December 20, 2025
• Primary Completion (Estimated): April 30, 2026
• Study Completion (Estimated): April 30, 2026

Study Registration Dates

• First Submitted: December 8, 2025
• First Submitted That Met QC Criteria: December 8, 2025
• First Posted (Actual): December 19, 2025

Study Record Updates

• Last Update Posted (Actual): December 19, 2025
• Last Update Submitted That Met QC Criteria: December 8, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: LBF8-03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No