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Strattice in Repair of Inguinal Hernias (RING)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
LifeCell
ClinicalTrials.gov Identifier:
NCT00681291
First received: May 15, 2008
Last updated: April 6, 2016
Last verified: April 2016

May 15, 2008
April 6, 2016
April 2008
June 2012   (final data collection date for primary outcome measure)
  • Change From Baseline in Activities Assessment Scale at 3 Months [ Time Frame: Baseline to 3 Months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 12 Months [ Time Frame: Baseline to 12 Months ] [ Designated as safety issue: No ]
    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 24 Months [ Time Frame: Baseline to 24 Months ] [ Designated as safety issue: No ]
    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.
Resumption of Activities of Daily Living [ Time Frame: POD 10 and Months 3, 6, 12 and 24 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00681291 on ClinicalTrials.gov Archive Site
Not Provided
  • Quality and severity of pain [ Time Frame: POD 10 and Months 3, 6, 12 and 24 ] [ Designated as safety issue: No ]
  • Incidence of chronic pain [ Time Frame: Month 12 ] [ Designated as safety issue: No ]
  • Postoperative wound events [ Time Frame: POD 10 and Month 3 ] [ Designated as safety issue: Yes ]
  • Analgesic consumption [ Time Frame: POD 1-10, Month 3 ] [ Designated as safety issue: No ]
  • Hernia recurrence [ Time Frame: Months 12 and 24 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Strattice in Repair of Inguinal Hernias
Prospective, Randomized, Controlled, Third-Party Blinded Multicenter Evaluation of Strattice/LTM in the Repair of Inguinal Hernias
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.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Hernia, Inguinal
  • Device: Inguinal hernia repair with Ultrapro
    surgical mesh (15x15cm) to support Lichtenstein repair
    Other Name: Ultrapro (Ethicon, Somerville NJ)
  • Device: Inguinal hernia repair with Strattice
    Surgical mesh (10x16) used to support Lichtenstein repair
    Other Name: Strattice Reconstructive Tissue Matrix
  • Active Comparator: 1
    lightweight polypropylene mesh
    Intervention: Device: Inguinal hernia repair with Ultrapro
  • Active Comparator: 2
    Strattice
    Intervention: Device: Inguinal hernia repair with Strattice
Bellows CF, Shadduck PP, Helton WS, Fitzgibbons RJ. The design of an industry-sponsored randomized controlled trial to compare synthetic mesh versus biologic mesh for inguinal hernia repair. Hernia. 2011 Jun;15(3):325-32. doi: 10.1007/s10029-010-0773-x. Epub 2011 Jan 8.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
172
June 2012
June 2012   (final data collection date for primary outcome measure)

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
Male
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00681291
LFC2007.04.01
No
Not Provided
Not Provided
LifeCell
LifeCell
Not Provided
Principal Investigator: Charles Bellows, MD, FACS Tulane University
Principal Investigator: Samir Awad, MD, FACS Baylor College of Medicine
Principal Investigator: Robert Fitzgibbons, MD, FACS Creighton University
LifeCell
April 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP