Strattice in Repair of Inguinal Hernias (RING)
This study has been completed.
Sponsor:
LifeCell
Information provided by (Responsible Party):
LifeCell
ClinicalTrials.gov Identifier:
NCT00681291
First received: May 15, 2008
Last updated: November 26, 2012
Last verified: November 2012
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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:
Genetics Home Reference related topics:
abdominal wall defect
MedlinePlus related topics:
Hernia
U.S. FDA Resources
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
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 Pathological Conditions, Anatomical Hernia, Abdominal |
ClinicalTrials.gov processed this record on May 19, 2013