MedTrace Logo

Tacking Mesh Versus Self-fixating Mesh for Inguinal Hernia Repair

NCT03247985 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2018-06-15

Study results available
· View outcomes & findings →

Summary

Investigators are testing whether tacking mesh or self-fixating mesh used for inguinal hernia repair makes any difference in short-term pain or return to normal activities following the operation. Other studies have shown no significant difference in hernia recurrence rate when metal tacks are not used to hold the mesh in place.

Conditions

  • Hernia, Inguinal

Interventions

DEVICE

PROLENE Polypropylene Tacking Mesh

Prolene mesh is a polypropylene plastic mesh (10 x 15 cm) implant fixed with titanium tacks

DEVICE

ProGrip Self-fixating Mesh

ProGrip™ self-fixating mesh is a tack-free fixation mesh for use in open \& laparoscopic hernia repairs. It is composed of absorbable Monofilament Polylactic Acid micro grips on one surface integrated with a lightweight Monofilament Polyethylene Terephthalate. The micro grips act as a kind of "Velcro" to the soft tissue surfaces resulting in self-fixation

Sponsors & Collaborators

Principal Investigators

  • David Farley · Mayo Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-06-30
Primary Completion
2015-11-30
Completion
2015-11-30
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03247985 on ClinicalTrials.gov