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