Use of Parietex Plug and Patch Hernia System in Open Inguinal Hernia Repair
Status unconfirmed
Conditions studied: Evaluate the Use of a New Mesh Type in Open Inguinal Hernia Repair
In brief
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
Key facts
- Study ID
- NCT01590940
- Run by
- Owen Drive Surgical Clinic of Fayetteville
- People needed
- 50
- Starts
- 2012-04-01
- Last updated by the study team
- 2012-05-04
Who can join
Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- All patients regardless of gender > 18 years of age presenting with inguinal hernias.
- Subjects will be informed of the nature of the study, and have provided signed written consent.
You may not qualify if…
- children under the age of 18
- subjects that meet criteria for biologic mesh placement
- emergency procedure
- recurrent hernias.
Where it is running
- Owen Drive Surgical Clinic of Fayetteville — Fayetteville, North Carolina, United States (enrolling)
Full record on ClinicalTrials.gov
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