Strattice in Repair of Inguinal Hernias
CompletedPhase 4NCT00681291
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- Prospective, Randomized, Controlled, Third-Party Blinded Multicenter Evaluation of Strattice/LTM in the Repair of Inguinal Hernias
- Conditions
- Interventions
- Device: Inguinal hernia repair with Ultrapro
- Device: Inguinal hernia repair with Strattice
- Sponsor
- LifeCell
- Start date
- 2008-04
- Primary completion
- 2012-06
- Sex
- Male
- Age range
- from 18 Years
- Results posted
- Yes, on ClinicalTrials.gov
- Countries
- United States
- Total sites listed
- 8
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * adult male * symptomatic and palpable inguinal hernia * open, elective, primary unilateral inguinal hernia repair Exclusion Criteria: * bilateral 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
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT00681291