Strattice in Repair of Inguinal Hernias

Hernia, Inguinal Clinical Trial

— RING  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00681291
• Other study ID #: LFC2007.04.01
• Status: Completed
• Phase: Phase 4
• First received: May 15, 2008
• Last updated: November 26, 2012
• Start date: April 2008
• Est. completion date: June 2012

Study information

• Verified date: November 2012
• Source: LifeCell
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 172
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Hernia
• Hernia, Inguinal

Intervention

Device:
• Inguinal hernia repair with Ultrapro
surgical mesh (15x15cm) to support Lichtenstein repair
• Inguinal hernia repair with Strattice
Surgical mesh (10x16) used to support Lichtenstein repair

Locations

Country	Name	City	State
United States	University of Maryland School of Medicine	Baltimore	Maryland
United States	Regional Surgical Associates	Durham	North Carolina
United States	Baylor College of Medicine	Houston	Texas
United States	Hospital of St Raphael	New Haven	Connecticut
United States	Tulane University Health Sciences Center	New Orleans	Louisiana
United States	Sentara Norfolk General Hospital	Norfolk	Virginia
United States	Creighton University	Omaha	Nebraska
United States	Oregon Health Sciences University	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
LifeCell

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Resumption of Activities of Daily Living		Months 3, 6, 12 and 24	No
Secondary	Quality and severity of pain		POD 10 and Months 3, 6, 12 and 24	No
Secondary	Incidence of chronic pain		Month 12	No
Secondary	Postoperative wound events		POD 10 and Month 3	Yes
Secondary	Analgesic consumption		POD 1-10, Month 3	No
Secondary	Hernia recurrence		Months 12 and 24	No