Strattice in Repair of Inguinal Hernias

Phase 4

Completed

Conditions: Hernia, Inguinal

Interventions: Device: Inguinal hernia repair with Ultrapro
Device: Inguinal hernia repair with Strattice

Registration Number: NCT00681291

Lead Sponsor: LifeCell

Brief 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: Male

Target Recruitment: 172

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Inguinal hernia repair with Ultrapro	lightweight polypropylene mesh
2	Inguinal hernia repair with Strattice	Strattice

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Activities Assessment Scale at 12 Months	Baseline to 12 Months	The AAS includes 13 items covering a broad sample of sedentary, movement-related and graded-intensity physical activities. Respondents are asked to rate the degree of difficulty performing each of these activities in the previous 24 hours on a 5-point scale from "No difficulty" to "Not able to do it." The AAS has three subscales: sedentary activities (items 1-4); ambulatory activities (items 6-8); work/exercise activities (items 11-13). The AAS total and subscale scores are transformed to produce a range of 0-100, with higher values indicating greater functional activity. Subjects completed the assessment at baseline, 3 months, 6 months, 12 months and 24 months. It is the change from baseline to 3, 6, 12 and 24 months which is the primary outcome measure (Baseline calculated value minus time point calculated value). Therefore, a negative number indicates an increase in activity from baseline.
Change From Baseline in Activities Assessment Scale at 6 Months	Baseline to 6 Months	The AAS includes 13 items covering a broad sample of sedentary, movement-related and graded-intensity physical activities. Respondents are asked to rate the degree of difficulty performing each of these activities in the previous 24 hours on a 5-point scale from "No difficulty" to "Not able to do it." The AAS has three subscales: sedentary activities (items 1-4); ambulatory activities (items 6-8); work/exercise activities (items 11-13). The AAS total and subscale scores are transformed to produce a range of 0-100, with higher values indicating greater functional activity. Subjects completed the assessment at baseline, 3 months, 6 months, 12 months and 24 months. It is the change from baseline to 3, 6, 12 and 24 months which is the primary outcome measure (Baseline calculated value minus time point calculated value). Therefore, a negative number indicates an increase in activity from baseline.
Change From Baseline in Activities Assessment Scale at 3 Months	Baseline to 3 Months	The AAS includes 13 items covering a broad sample of sedentary, movement-related and graded-intensity physical activities. Respondents are asked to rate the degree of difficulty performing each of these activities in the previous 24 hours on a 5-point scale from "No difficulty = 1" to "Not able to do it = 5." The AAS has three subscales: sedentary activities (items 1-4); ambulatory activities (items 6-8); work/exercise activities (items 11-13). The AAS total and subscale scores are transformed to produce a range of 0-100, with higher values indicating greater functional activity. Subjects completed the assessment at baseline, 3 months, 6 months, 12 months and 24 months. It is the change from baseline to 3, 6, 12 and 24 months which is the primary outcome measure (Baseline calculated value minus time point calculated value). Therefore, a negative number indicates an increase in activity from baseline.
Change From Baseline in Activities Assessment Scale at 24 Months	Baseline to 24 Months	The AAS includes 13 items covering a broad sample of sedentary, movement-related and graded-intensity physical activities. Respondents are asked to rate the degree of difficulty performing each of these activities in the previous 24 hours on a 5-point scale from "No difficulty" to "Not able to do it." The AAS has three subscales: sedentary activities (items 1-4); ambulatory activities (items 6-8); work/exercise activities (items 11-13). The AAS total and subscale scores are transformed to produce a range of 0-100, with higher values indicating greater functional activity. Subjects completed the assessment at baseline, 3 months, 6 months, 12 months and 24 months. It is the change from baseline to 3, 6, 12 and 24 months which is the primary outcome measure (Baseline calculated value minus time point calculated value). Therefore, a negative number indicates an increase in activity from baseline.

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (8): Oregon Health Sciences University
🇺🇸
Portland, Oregon, United States
Tulane University Health Sciences Center
🇺🇸
New Orleans, Louisiana, United States
Creighton University
🇺🇸
Omaha, Nebraska, United States
Hospital of St Raphael
🇺🇸
New Haven, Connecticut, United States
University of Maryland School of Medicine
🇺🇸
Baltimore, Maryland, United States
Regional Surgical Associates
🇺🇸
Durham, North Carolina, United States
Sentara Norfolk General Hospital
🇺🇸
Norfolk, Virginia, United States
Baylor College of Medicine
🇺🇸
Houston, Texas, United States