Strattice in Repair of Inguinal Hernias (RING)

LifeCell

Status and phase: Completed; Phase 4

Conditions: Hernia, Inguinal

Treatments: Device: Inguinal hernia repair with Strattice; Device: Inguinal hernia repair with Ultrapro

Study type: Interventional

Funder types: Industry

Identifiers

NCT00681291

LFC2007.04.01

Details and patient eligibility

About

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.

Enrollment: 172 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

172 participants in 2 patient groups

1

Active Comparator group

Description:

lightweight polypropylene mesh

Treatment:

Device: Inguinal hernia repair with Ultrapro

2

Active Comparator group

Description:

Strattice

Treatment:

Device: Inguinal hernia repair with Strattice