Strattice in Repair of Inguinal Hernias (RING)

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

LifeCell

ClinicalTrials.gov Identifier:

NCT00681291

First received: May 15, 2008

Last updated: November 26, 2012

Last verified: November 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

May 15, 2008

Last Updated Date

November 26, 2012

Start Date ^ICMJE

April 2008

Primary Completion Date

June 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Resumption of Activities of Daily Living [ Time Frame: Months 3, 6, 12 and 24 ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Resumption of Activities of Daily Living [ Time Frame: POD 10 and Months 3, 6, 12 and 24 ] [ Designated as safety issue: No ]

Change History

Complete list of historical versions of study NCT00681291 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Quality and severity of pain [ Time Frame: POD 10 and Months 3, 6, 12 and 24 ] [ Designated as safety issue: No ]
Incidence of chronic pain [ Time Frame: Month 12 ] [ Designated as safety issue: No ]
Postoperative wound events [ Time Frame: POD 10 and Month 3 ] [ Designated as safety issue: Yes ]
Analgesic consumption [ Time Frame: POD 1-10, Month 3 ] [ Designated as safety issue: No ]
Hernia recurrence [ Time Frame: Months 12 and 24 ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Strattice in Repair of Inguinal Hernias

Official Title ^ICMJE

Prospective, Randomized, Controlled, Third-Party Blinded Multicenter Evaluation of Strattice/LTM in the Repair of Inguinal Hernias

Brief Summary

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Hernia, Inguinal

Intervention ^ICMJE

Device: Inguinal hernia repair with Ultrapro
surgical mesh (15x15cm) to support Lichtenstein repair

Other Name: Ultrapro (Ethicon, Somerville NJ)
Device: Inguinal hernia repair with Strattice
Surgical mesh (10x16) used to support Lichtenstein repair

Other Name: Strattice Reconstructive Tissue Matrix

Study Arm (s)

Active Comparator: 1
lightweight polypropylene mesh

Intervention: Device: Inguinal hernia repair with Ultrapro
Active Comparator: 2
Strattice

Intervention: Device: Inguinal hernia repair with Strattice

Publications *

Bellows CF, Shadduck PP, Helton WS, Fitzgibbons RJ. The design of an industry-sponsored randomized controlled trial to compare synthetic mesh versus biologic mesh for inguinal hernia repair. Hernia. 2011 Jun;15(3):325-32. Epub 2011 Jan 8.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

172

Completion Date

June 2012

Primary Completion Date

June 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

bilater 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

Gender

Male

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00681291

Other Study ID Numbers ^ICMJE

LFC2007.04.01

Has Data Monitoring Committee

Responsible Party

LifeCell

Study Sponsor ^ICMJE

LifeCell

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:	Charles Bellows, MD, FACS	Tulane University
Principal Investigator:	Samir Awad, MD, FACS	Baylor College of Medicine
Principal Investigator:	Robert Fitzgibbons, MD, FACS	Creighton University

Information Provided By

LifeCell

Verification Date

November 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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