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
  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 4

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

Resource links provided by NLM:


Further study details as provided by LifeCell:

Primary Outcome Measures:
  • Resumption of Activities of Daily Living [ Time Frame: 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 ]

Enrollment: 172
Study Start Date: April 2008
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
lightweight polypropylene mesh
Device: Inguinal hernia repair with Ultrapro
surgical mesh (15x15cm) to support Lichtenstein repair
Other Name: Ultrapro (Ethicon, Somerville NJ)
Active Comparator: 2
Strattice
Device: Inguinal hernia repair with Strattice
Surgical mesh (10x16) used to support Lichtenstein repair
Other Name: Strattice Reconstructive Tissue Matrix

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Connecticut
Hospital of St Raphael
New Haven, Connecticut, United States, 06511
United States, Louisiana
Tulane University Health Sciences Center
New Orleans, Louisiana, United States, 70112
United States, Maryland
University of Maryland School of Medicine
Baltimore, Maryland, United States, 21201
United States, Nebraska
Creighton University
Omaha, Nebraska, United States, 68178
United States, North Carolina
Regional Surgical Associates
Durham, North Carolina, United States, 27704
United States, Oregon
Oregon Health Sciences University
Portland, Oregon, United States, 97239
United States, Texas
Baylor College of Medicine
Houston, Texas, United States, 77030
United States, Virginia
Sentara Norfolk General Hospital
Norfolk, Virginia, United States, 23507
Sponsors and Collaborators
LifeCell
Investigators
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
  More Information

No publications provided by LifeCell

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: LifeCell
ClinicalTrials.gov Identifier: NCT00681291     History of Changes
Other Study ID Numbers: LFC2007.04.01
Study First Received: May 15, 2008
Last Updated: November 26, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by LifeCell:
surgical mesh
inguinal hernia repair
chronic groin pain

Additional relevant MeSH terms:
Hernia
Hernia, Inguinal
Hernia, Abdominal
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on October 21, 2014