Safety and Performance Study of TIGR Matrix Surgical Mesh in Inguinal Hernia Repair
This an open, uncontrolled multicenter clinical study to assess the safety and performance of the WK-6 surgical mesh in adult patients with unilateral inguinal hernia.
The primary objective is to determine the safety of the WK-6 surgical mesh. Data will be compared retrospectively with published studies on inguinal hernia mesh.
The secondary objectives are to explore the performance of the surgical mesh by measuring the pain pre and post surgery as well as a number of relevant variables for establishing the performance of the mesh. Data will be compared retrospectively with previous studies on inguinal hernia mesh with a follow-up of at least one year.
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Safety and Performance Study of TIGR Matrix Surgical Mesh in Inguinal Hernia Repair|
- Frequency of Adverse Events or Serious Adverse Events [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]Safety is assessed by monitoring the incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs) related and unrelated to the mesh and rehabilitation. AEs and SAEs will be collected during surgery and throughout the follow up period. Possible adverse reactions with the use of any prosthesis may include but are not limited to infection, inflammation, extrusion, dhesion, fistula formation, seroma formation, hematoma, and recurrence of the hernia or tissue defect.
- Pain [ Time Frame: 12 months ] [ Designated as safety issue: No ]The experienced pain will be measured by an ungraded Visual Analogue Scale (VAS). VAS will be assessed before the surgery and during the follow up period and elucidate the pain experienced during different conditions. A symptoms questionnaire and an analgesics diary will be used to assess the performance of the WK-6 surgical mesh for use in inguinal hernia repair.
|Study Start Date:||April 2009|
|Study Completion Date:||March 2011|
|Primary Completion Date:||April 2010 (Final data collection date for primary outcome measure)|
Device: TIGR Matrix Surgical Mesh
Lichtenstein repair of inguinal hernia using TIGR Matrix Surgical Mesh
|Sahlgrenska University Hospital|
|Principal Investigator:||Stellan Björck, MD, PhD||Sahlgrenska University Hospital, Sweden|