PMCF Study of LiquiBand FIX8® OHMF Device (LBF8-Open)

PMCF Study to Evaluate the Safety and Performance of LiquiBand FIX8® Open Hernia Mesh Fixation Device

Study to evaluate the safety and performance of LiquiBand FIX8® Open Hernia Mesh Fixation Device.

Study Overview

• Status: Recruiting
• Conditions: Inguinal Hernia
• Intervention / Treatment: Device: LiquiBand FIX8 Open Hernia Mesh Fixation Device

• Study Type: Interventional
• Enrollment (Estimated): 107
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tina Warburton; Phone Number: 01606863500; Email: tina.warburton@admedsol.com
• Study Contact Backup: Name: Rebecca Forder; Phone Number: 01606863500; Email: rebecca.forder@admedsol.com

Study Locations

• United Kingdom
  • Ashton-under-Lyne, United Kingdom
    • Recruiting
    • Tameside General Hospital
    • Contact: Andrei Mihailescu
  • Great Yarmouth, United Kingdom, NR31 6LA
    • Recruiting
    • James Paget University Hospitals NHS Foundation Trust
    • Contact: Christopher Liao
  • Wirral, United Kingdom, CH49 5PE
    • Recruiting
    • Wirral University Teaching Hospital NHS Foundation Trust
    • Contact: Conor Magee

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Subject is able to understand and give informed consent to take part in the study
• Subject has a primary inguinal hernia.
• Subject is scheduled to undergo open inguinal hernia repair using the LiquiBand FIX8® OHMF device.
• Subject is willing and able to comply with the protocol assessments at time of surgery and during the post-surgical follow-up period.

Exclusion Criteria:

• Subject is undergoing open repair surgery for recurrent hernia, where the primary surgery was also open. Subjects with recurrent hernia whose primary surgery was laparoscopic are not excluded.
• Subject has an anatomical defect or had prior surgical procedures that in the opinion of the investigator makes them unsuitable for open hernia repair with the LiquiBand FIX8® OHMF device.
• Subject is known to be non-compliant with medical treatment.
• Subject is pregnant or actively breastfeeding.
• Subject has any significant or unstable medical or psychiatric condition that, in the opinion of the Investigator, would interfere with his/her ability to participate in the study.
• Subject has a known sensitivity to cyanoacrylate or formaldehyde, D&C Violet No.2 dye or any other component of LiquiBand FIX8® OHMF device.
• The hernia mesh to be used in the repair is constructed from Polytetrafluoroethylene (PTFE) or absorbable materials.
• The hernia mesh to be used in the repair is a self-gripping mesh (e.g. ProGrip).
• Subject has active or potential infection at the surgical site.
• Subject has a history of keloid formation.
• Subject has a known vitamin C or zinc deficiency.
• Subject has a connective tissue disorder.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LiquiBand FIX8® OHMF Device; Subjects will undergo hernia mesh fixation and topical wound closure using the LiquiBand FIX8® OHMF device.	Device: LiquiBand FIX8 Open Hernia Mesh Fixation Device; Subjects will undergo hernia mesh fixation and topical wound closure using the LiquiBand FIX8® OHMF device. Subjects will be evaluated intra-operatively, post-operatively, at discharge, and at 12 months post-operatively. The Liquiband surgical study device is considered a permanent implant.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effectiveness of the LiquiBand FIX8 OHMF device	Effectiveness will be defined as successful fixation of the hernia mesh (ie not requiring additional fixation by an alternate device) using the LiquiBand FIX8 device at the time of surgery. Based on data pooled from published studies of a similar device (which employs the same cyanoacrylate glue to fix hernia mesh, via a laparoscopic rather than open surgical approach), there has been an observed failure rate of 0.8% in mesh fixation. This study aims to demonstrate non-inferiority of the LiquiBand FIX8 device to a failure rate of 5% (medically acceptable inference).	Time of surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety of the LiquiBand FIX8 OHMF device	The incidence of adverse events (whether or not determined to be related to the LiquiBand FIX8 Device) will be recorded. Complications assessed during the study will include: Haematoma; Seroma; Testicular ischaemia and atrophy; Surgical site or wound infection/dehiscence; Mesh infection; Chronic post-operative pain (lasting ≥ 12 months post-surgery	0 (intra-operatively), up to 2 days (discharge from hospital) and 12-months post surgery
Effectiveness of the LiquiBandFIX8 OHMF device for topical wound closure	Defined as successful closure of the incision site using the LiquiBand FIX8 Device (not requiring additional fixation by an alternate device).	Time of surgery
Assessment of chronic post-operative pain using the Visual Analogue Scale: the minimal clinically important difference and patient acceptable symptom state.	Chronic post-operative pain will be assessed using the following measures: Improvement in post-operative pain from baseline to 12 months post-surgery as measured by the Visual Analogue Scale (0 = no pain to 10 = most pain imaginable); and; Analgesic requirements in the 12 months post-surgery	12-months post-surgery
Long term performance of the study device	Long-term performance will be assessed by rate of hernia recurrence.	12-months post surgery
Comparison of cost-effectiveness of patients treated with the LiquiBand FIX8 OHMF device compared with costs for those treated using standard surgical technique.	A study-specific outcome model will be used, which will calculate an incremental cost effectiveness ratio (ICER) in terms of quality-adjusted life years (QALYs) achieved with the introduction of the LiquiBand FIX8 OHMF device compared with using a standard surgical technique (suture fixation).	12-months
Comparison of costs of patients' clinical events treated with the LiquiBand FIX8 OHMF device compared with costs for those treated using standard surgical technique.	A study-specific outcome model will be used which will calculate an incremental cost effectiveness ratio (ICER) given in terms of clinical events avoided achieved with the introduction of the LiquiBand FIX8 OHMF device compared with using a standard surgical technique (suture fixation).	12-months
Clinician satisfaction	Users will be asked to rate the device on factors relating to ease of use and satisfaction, compared with their experience of other hernia mesh fixation devices. Satisfaction will be assessed using a Likert-type scale (e.g. Very satisfied (1), Satisfied (2), Neither (3), Dissatisfied (4), Very dissatisfied (5))	0 (Post Surgery) and upto 2 days (hospital discharge)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cosmesis of wound closure using the Visual Analogue Scale	Cosmesis of the wound closure will be assessed by the investigator and patient, and measured by Visual Analogue Scale (0 = Very poor cosmetic outcome; to 10 = very good cosmetic outcome).	12-months

Collaborators and Investigators

• Sponsor: Advanced Medical Solutions Ltd.
• Collaborators: Imarc Research, Inc.
• Investigators: Principal Investigator: Andrei Mihailescu, MD, Tameside & Glossop Integrated Care NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start (Actual): December 7, 2021
• Primary Completion (Estimated): May 1, 2025
• Study Completion (Estimated): August 1, 2025

Study Registration Dates

• First Submitted: August 9, 2019
• First Submitted That Met QC Criteria: August 15, 2019
• First Posted (Actual): August 16, 2019

Study Record Updates

• Last Update Posted (Actual): September 6, 2023
• Last Update Submitted That Met QC Criteria: September 4, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Inguinal Hernia; Mesh Fixation; Surgical Site Wound Closure
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Hernia, Abdominal; Hernia; Hernia, Inguinal
• Other Study ID Numbers: OHMF-001

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
• product manufactured in and exported from the U.S.: No