Strattice in Repair of Inguinal Hernias

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

172 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-30

Study Completion Date

2012-06-30

Brief Summary

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This is a prospective, randomized, controlled, third-party blinded, multicenter, interventional evaluation of inguinal hernia repair comparing Strattice to light weight polypropylene mesh. Performance and outcomes measures to be compared include postoperative resumption of activities of daily living, nature and incidence of short- and long-term pain and complications, and incidence of hernia recurrence.

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Detailed Description

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Conditions

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Hernia, Inguinal

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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1

lightweight polypropylene mesh

Group Type ACTIVE_COMPARATOR

Inguinal hernia repair with Ultrapro

Intervention Type DEVICE

surgical mesh (15x15cm) to support Lichtenstein repair

2

Strattice

Group Type ACTIVE_COMPARATOR

Inguinal hernia repair with Strattice

Intervention Type DEVICE

Surgical mesh (10x16) used to support Lichtenstein repair

Interventions

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Inguinal hernia repair with Ultrapro

surgical mesh (15x15cm) to support Lichtenstein repair

Intervention Type DEVICE

Inguinal hernia repair with Strattice

Surgical mesh (10x16) used to support Lichtenstein repair

Intervention Type DEVICE

Other Intervention Names

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Ultrapro (Ethicon, Somerville NJ) Strattice Reconstructive Tissue Matrix

Eligibility Criteria

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Inclusion Criteria

* adult male
* symptomatic and palpable inguinal hernia
* open, elective, primary unilateral inguinal hernia repair

Exclusion Criteria

* bilateral inguinal hernia repair
* BMI \>35
* chronic immunosuppression, active chemo/radiation therapy, uncontrolled diabetes, severe liver disease or COPD
* chronic prostatitis, orchitis, testicular pain
* local or systemic infection at time of repair
* known collagen disorder
* chronic pain syndrome or under active pain management

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No