A Clinical Study to Evaluate the Clinical Performance and Safety of LiquiBand FIX8® Versus AbsorbaTack™ for Hernia Mesh Fixation and Peritoneal Closure in Groin Hernia Repair
CompletedNAResults postedLast updated 11 January 2024
What this trial tests
NA trial testing LiquiBand FIX8® in Hernia in 284 participants. Completed in 23 November 2022.
22 and older, any sex, with Hernia or Inguinal Hernia. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Change in PainPrimary· Assessed at pre-surgery (baseline), day 7, day 14, month 1, month 3 and month 6 post surgery. Change from baseline at month 6 reported.
Change in pain from baseline to 6 month will be assessed and compared to treatment with AbsorbaTack™ in subjects requiring laparoscopic (TEP and TAPP) hernia repair where the VAS value is 0 - 10, 0 = no pain and 10 = worst pain imaginable.
Group
Value
95% CI
LiquiBand FIX8®
-4.9
± 2.5
AbsorbaTack™
-5.1
± 2.3
Number of Participants With Hernia RecurrenceSecondary· Assessed at week 2, month 3, month 6 and month 12 post surgery. Month 12 post surgery reported
The incidence of hernia recurrence was assessed by physical examination and confirmed by ultrasound imaging following physical examination. Also, the study sites were guided to ask the subjects 3 questions during the clinic visit performed remotely with a 'Yes' or 'No' response; 1. Do you think your hernia has come back? 2. Do you feel or see a bulge? and 3. Do you have physical pain or symptoms at the site?
Group
Value
95% CI
LiquiBand FIX8®
1
AbsorbaTack™
2
Successful Mesh Fixation at the Time of Surgery.Secondary· Time of surgery.
LiquiBand FIX8® was required to successfully fix hernia mesh at a rate non-inferior to control device (AbsorbaTack™). Successful mesh fixation did not require any additional fixation by alternate fixation device.
Group
Value
95% CI
LiquiBand FIX8®
142
AbsorbaTack™
142
Incidence of Successful Peritoneal Closure (TAPP Repairs Only)Secondary· Time of surgery.
LiquiBand FIX8® was required to successfully approximate the peritoneum at a rate non-inferior to control device. Successful peritoneal closure did not require any additional fixation by alternate fixation device or additional procedure.
Group
Value
95% CI
LiquiBand FIX8®
82
AbsorbaTack™
84
Quality of Life as Measured by the Carolinas Comfort Scale (CCS).Secondary· Pre-Surgery, Week 1, Week 2, Month 1, Month 3, Month 6, Month 9 and Month 12 post surgery
Quality of Life was assessed by completion of the Carolinas Comfort Scale (CCS) Questionnaire. CCS scores at each timepoint were compared between the LiquiBand FIX8® and control (AbsorbaTack) treatment groups. Carolinas Comfort Scale measures quality of life through a 23-item, Likert-type questionnaire that measures severity of pain, sensation of mesh and movement limitations in eight categories: laying down, bending over, sitting up, activities of daily living, coughing or deep breathing, walking, stairs and exercise. The subscales scores for pain (0-40), sensation of mesh (0-40) and movement
Change from 1 week to 2 weeks
Group
Value
95% CI
LiquiBand FIX8®
-7.7
± 12.4
AbsorbaTack™
-7.0
± 13.2
Change from 1 week to 1 month
Group
Value
95% CI
LiquiBand FIX8®
-12.4
± 12.6
AbsorbaTack™
-12.2
± 14.6
Change from 1 week to 3 months
Group
Value
95% CI
LiquiBand FIX8®
-14.6
± 16.9
AbsorbaTack™
-14.4
± 15.9
Change from 1 week to 6 months
Group
Value
95% CI
LiquiBand FIX8®
-15.1
± 16.0
AbsorbaTack™
-15.3
± 16.7
Change from 1 week to 9 months
Group
Value
95% CI
LiquiBand FIX8®
-15.6
± 16.3
AbsorbaTack™
-15.7
± 16.5
Change from 1 week to 12 months
Group
Value
95% CI
LiquiBand FIX8®
-15.6
± 16.0
AbsorbaTack™
-15.3
± 16.1
Levels of Pain Experienced as Measured by Visual Analogue Scale (VAS).Secondary· Evaluation of pain will be measured at pre-surgery, discharge (up to 3 days), Week 1, Week 2, Month 1, Month 3, Month 6, Month 9 and Month 12 post surgery
A Visual Analog Scale (VAS) was used as a measure of pain where the VAS value is 0 - 10, 0 = no pain and 10 = worst pain imaginable.
Change from pre-surgery to discharge
Group
Value
95% CI
LiquiBand FIX8®
-0.3
± 3.4
AbsorbaTack™
-0.1
± 3.5
Change from pre-surgery to 1 week
Group
Value
95% CI
LiquiBand FIX8®
-1.5
± 2.8
AbsorbaTack™
-1.5
± 3.1
Change from pre-surgery to 2 weeks
Group
Value
95% CI
LiquiBand FIX8®
-2.8
± 2.8
AbsorbaTack™
-2.7
± 2.9
Change from pre-surgery to 1 month
Group
Value
95% CI
LiquiBand FIX8®
-3.2
± 2.8
AbsorbaTack™
-3.1
± 3.1
Change from pre-surgery to 3 months
Group
Value
95% CI
LiquiBand FIX8®
-3.6
± 2.9
AbsorbaTack™
-3.4
± 3.1
Change from pre-surgery to 6 months
Group
Value
95% CI
LiquiBand FIX8®
-3.6
± 3.0
AbsorbaTack™
-3.5
± 3.1
Change from pre-surgery to 9 months
Group
Value
95% CI
LiquiBand FIX8®
-3.7
± 2.9
AbsorbaTack™
-3.5
± 3.0
Change from pre-surgery to 12 months
Group
Value
95% CI
LiquiBand FIX8®
-3.6
± 2.9
AbsorbaTack™
-3.5
± 3.1
Safety as Measured by the Incidence of Adverse Events.Secondary· Intraoperatively, Discharge, Week 1, Week 2, Month 1, Month 3, Month 6, Month 9 and Month 12 post surgery
The number of all adverse events whether or not determined to be related to the LiquiBand FIX8® device or control device (AbsorbaTack™).
Group
Value
95% CI
LiquiBand FIX8®
114
AbsorbaTack™
157
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse Event data was collected from time of randomization through 12 month follow up.
Reporting threshold: 3%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This is a multi-center, randomized controlled trial of 284 subjects (142 in each group). Patients will be blinded to the fixation method used. The objective of this study is to compare the efficacy and safety of the LiquiBand FIX8® device to the tack-based control device (AbsorbaTack™) for laparoscopic groin hernia (inguinal or femoral) repair. The primary outcome measure is an improvement in pain score measured by VAS at 6 months. Secondary outcomes include the ability to affix hernia mesh, the ability to approximate the peritoneum, recurrence rate, and quality of life (Carolina Comfort Scale).
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Advanced Medical Solutions Ltd.
Last refreshed: 11 January 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04009213.