Clinical trial NCT04059640: PMCF Study of LiquiBand FIX8® OHMF Device
Official title: PMCF Study to Evaluate the Safety and Performance of LiquiBand FIX8® Open Hernia Mesh Fixation Device
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Inguinal Hernia
Keywords: Inguinal Hernia
Mesh Fixation
Surgical Site Wound Closure
Lead sponsor: Advanced Medical Solutions Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Imarc Research, Inc.
First posted: 2019-08-16
Enrollment: 107
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: Effectiveness of the LiquiBand FIX8 OHMF device
timeFrame: Time of surgery
Secondary outcomes:
measure: Safety of the LiquiBand FIX8 OHMF device
timeFrame: 0 (intra-operatively), up to 2 days (discharge from hospital) and 12-months post surgery
measure: Effectiveness of the LiquiBandFIX8 OHMF device for topical wound closure
timeFrame: Time of surgery
measure: Assessment of chronic post-operative pain using the Visual Analogue Scale: the minimal clinically important difference and patient acceptable symptom state.
timeFrame: 12-months post-surgery
measure: Long term performance of the study device
timeFrame: 12-months post surgery
measure: Comparison of cost-effectiveness of patients treated with the LiquiBand FIX8 OHMF device compared with costs for those treated using standard surgical technique.
timeFrame: 12-months
measure: Comparison of costs of patients' clinical events treated with the LiquiBand FIX8 OHMF device compared with costs for those treated using standard surgical technique.
timeFrame: 12-months
measure: Clinician satisfaction
timeFrame: 0 (Post Surgery) and upto 2 days (hospital discharge)
Other outcomes:
measure: Cosmesis of wound closure using the Visual Analogue Scale
timeFrame: 12-months
Locations:
city: Ashton-under-Lyne
country: United Kingdom
facility: Tameside General Hospital
city: Great Yarmouth
country: United Kingdom
facility: James Paget University Hospitals NHS Foundation Trust
city: Wirral
country: United Kingdom
facility: Wirral University Teaching Hospital NHS Foundation Trust
Study officials:
affiliation: Tameside & Glossop Integrated Care NHS Foundation Trust
name: Andrei Mihailescu, MD
role: PRINCIPAL_INVESTIGATOR
References: