Phase 4
N=172
Strattice in Repair of Inguinal Hernias
Hernia, Inguinal
Bottom Line
View on ClinicalTrials.gov: NCT00681291 ↗Enrolled (actual)
172
Serious AEs
3.5%
Results posted
Mar 2016
Primary outcome: Primary: Change From Baseline in Activities Assessment Scale at 3 Months — -7.49; -6.12 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Inguinal hernia repair with Ultrapro (Device); Inguinal hernia repair with Strattice (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- LifeCell
- Primary completion
- Jun 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Activities Assessment Scale at 3 Months |
-7.49; -6.12 | — |
| PRIMARY Change From Baseline in Activities Assessment Scale at 6 Months |
-8.17; -7.20 | — |
| PRIMARY Change From Baseline in Activities Assessment Scale at 12 Months |
-8.78; -7.61 | — |
| PRIMARY Change From Baseline in Activities Assessment Scale at 24 Months |
-7.57; -7.53 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00681291). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.