Study to evaluate the safety and performance of LiquiBand FIX8® Open Hernia Mesh Fixation Device.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
109
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.
Tameside General Hospital
Ashton-under-Lyne, United Kingdom
James Paget University Hospitals NHS Foundation Trust
Great Yarmouth, United Kingdom
Wirral University Teaching Hospital NHS Foundation Trust
Metropolitan Borough of Wirral, United Kingdom
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 frame: Time of surgery
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
Time frame: 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 frame: 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
Time frame: 12-months post-surgery
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Long term performance of the study device
Long-term performance will be assessed by rate of hernia recurrence.
Time frame: 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).
Time frame: 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).
Time frame: 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))
Time frame: 0 (Post Surgery) and upto 2 days (hospital discharge)