Clinical Trial: Strattice in Repair of Inguinal Hernias

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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 Summary:
Sponsor: LifeCell

Current Primary Outcome:

  • Change From Baseline in Activities Assessment Scale at 3 Months [ Time Frame: 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 6 Months [ Time Frame: 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

    Original Primary Outcome: Resumption of Activities of Daily Living [ Time Frame: POD 10 and Months 3, 6, 12 and 24 ]

    Current Secondary Outcome:

    Original Secondary Outcome:

    • Quality and severity of pain [ Time Frame: POD 10 and Months 3, 6, 12 and 24 ]
    • Incidence of chronic pain [ Time Frame: Month 12 ]
    • Postoperative wound events [ Time Frame: POD 10 and Month 3 ]
    • Analgesic consumption [ Time Frame: POD 1-10, Month 3 ]
    • Hernia recurrence [ Time Frame: Months 12 and 24 ]


    Information By: LifeCell

    Dates:
    Date Received: May 15, 2008
    Date Started: April 2008
    Date Completion:
    Last Updated: April 6, 2016
    Last Verified: April 2016