PMCF Study of LiquiBand FIX8® OHMF Device

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

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

Conditions
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Inguinal Hernia

Intervention / Treatment
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* Device: LiquiBand FIX8 Open Hernia Mesh Fixation Device


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LiquiBand FIX8® OHMF Device<br>Subjects will undergo hernia mesh fixation and topical wound closure using the LiquiBand FIX8® OHMF device. | Device: LiquiBand FIX8 Open Hernia Mesh Fixation Device<br>* 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.<br>|

What is the study measuring?
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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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Inguinal Hernia, Mesh Fixation, Surgical Site Wound Closure