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You can access this
clinical trial
if you have
Evaluate the Use of a New Mesh Type in Open Inguinal Hernia Repair
and you are
between 18 and 90
years old
-
This is an observational trial.
You are contributing to medical knowledge about your condition.
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The purpose

The use of synthetic mesh plugs for open inguinal hernia repair has seen dramatic variability in the number and composition of meshes currently on the world market. The use of biomaterials (PLLA, PGA) in hernia mesh is a relatively new and innovative method. These selected polymers have the ability to degrade while implanted, allowing for sufficient natural tissue healing and scarring. This usage presumably favors a decrease in foreignness, inflammatory reaction, recurrence, and incidence of chronic groin pain. Prior studies with similar plug meshes in the same indication have yielded favorable results which require this mesh to be investigated in its specific application. Primary Objective Evaluate the incidence of peri-operative and post-operative complications after the application of the Parietex plug and patch hernia system in open inguinal hernia repair. We will assess the efficacy of this mesh by examination and the application of a pain scale at the following intervals: 1 month, 3 months, and 1 year, respectively. Assessment is intended to evaluate: - Patient report of pain via their Pain score - Wound complication - Incidence of chronic groin pain - Recurrence rate - Other complications Secondary Objectives Record the description and assessment of the Parietex plug and patch hernia system: - surgical technique - description of dissection and mesh placement - method of fixation - operative times, anesthesia choice - length of hospital stay - mesh handling characteristics - return to daily activities - overall patient satisfaction

Provided treatments

  • Procedure: Open inguinal hernia repair with mesh

Locations near you

Unfortunately, there are no recruiting locations near you. Please check the list with all locations below.
Tris trial is registered with FDA with number: NCT01590940. The sponsor of the trial is Owen Drive Surgical Clinic of Fayetteville and it is looking for 50 volunteers for the current phase.
Official trial title:
Use of Parietex Plug-and-patch Hernia Mesh in Elective Open Inguinal Hernia Repair: A Pilot Investigation