Strattice in Repair of Inguinal Hernias - Full Text View

Sponsored by:	LifeCell
Information provided by:	LifeCell
ClinicalTrials.gov Identifier:	NCT00681291

Purpose

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.

Condition	Intervention	Phase
Hernia, Inguinal	Device: Inguinal hernia repair with Ultrapro Device: Inguinal hernia repair with Strattice	Phase IV

MedlinePlus related topics: Hernia

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
Official Title:	Prospective, Randomized, Controlled, Third-Party Blinded Multicenter Evaluation of Strattice/LTM in the Repair of Inguinal Hernias

Further study details as provided by LifeCell:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	170
Study Start Date:	April 2008
Estimated Study Completion Date:	March 2011
Estimated Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator lightweight polypropylene mesh	Device: Inguinal hernia repair with Ultrapro surgical mesh (15x15cm) to support Lichtenstein repair
2: Active Comparator Strattice	Device: Inguinal hernia repair with Strattice Surgical mesh (10x16) used to support Lichtenstein repair

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00681291

Locations

United States, Connecticut
Hospital of St Rafael	Recruiting
New Haven, Connecticut, United States, 06511
Contact: Scott Helton 203-789-3501
Principal Investigator: Scott Helton, MD, FACS
United States, Louisiana
Tulane University Health Sciences Center	Recruiting
New Orleans, Louisiana, United States, 70112
Contact: Nancy Logan 504-988-7889
Principal Investigator: Charles Bellows, MD, FACS
United States, Nebraska
Creighton University	Recruiting
Omaha, Nebraska, United States, 68178
Contact: Rene Christian 402-280-4538
Principal Investigator: Robert J Fitzgibbons, Jr, MD, FACS
United States, North Carolina
North Carolina Specialty Hospital	Recruiting
Durham, North Carolina, United States, 27704
Contact: Lisa Edgerton 919-313-6026
Principal Investigator: Phillip Shadduck, MD
United States, Oregon
Oregon Health Sciences University	Recruiting
Portland, Oregon, United States, 97239
Contact: Debra Drake 505-494-4949
Principal Investigator: Robert Martindale, MD, FACS
United States, Texas
Baylor College of Medicine	Recruiting
Houston, Texas, United States, 77030
Contact: Samir Awad 713-794-8737
Principal Investigator: Samir Awad, MD, FACS

Sponsors and Collaborators

LifeCell

Investigators

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

More Information

Responsible Party:	Lifecell Corporation ( Randi Rutan )
Study ID Numbers:	LFC2007.04.01
Study First Received:	May 15, 2008
Last Updated:	January 8, 2009
ClinicalTrials.gov Identifier:	NCT00681291
Health Authority:	United States: Institutional Review Board

Keywords provided by LifeCell:

surgical mesh
inguinal hernia repair
chronic groin pain

Study placed in the following topic categories:

Pathological Conditions, Anatomical
Hernia
Hernia, Abdominal
Pain
Hernia, Inguinal

ClinicalTrials.gov processed this record on January 14, 2009