Recruiting

Parietex Plug & Patch

Sponsor:

Owen Drive Surgical Clinic of Fayetteville

Code:

NCT01590940

Conditions

Evaluate the Use of a New Mesh Type in Open Inguinal Hernia Repair

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Open inguinal hernia repair with mesh

Study Details

Brief summary:

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

Conditions

Evaluate the Use of a New Mesh Type in Open Inguinal Hernia Repair

Study ID

NCT01590940

Start date

Apr, 2012

Status verified date

May, 2012

Primary completion date

Apr, 2013

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • children under the age of 18
  • subjects that meet criteria for biologic mesh placement
  • emergency procedure
  • recurrent hernias.

Study Design

Enrollment

50 participants

Anticipated

Interventions and Outcome Measures

Arms

Parietex mesh

Enrolled patients who met criteria for inclusion would have undergone open inguinal hernia repair using the Parietex plug and patch hernia system

Interventions

Open inguinal hernia repair with mesh

Central Contacts and Locations

Central contacts

Locations

Owen Drive Surgical Clinic of Fayetteville

Recruiting

Fayetteville, North Carolina, United States, 28304

Contacts

Principal Investigator:

F A Morfesis, M.D.

More Information

Sponsor

Owen Drive Surgical Clinic of Fayetteville

Last update posted

May 4, 2012

Last verified

May, 2012

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Owen Drive Surgical Clinic of Fayetteville on 2012-05-04.