Strattice in Repair of Inguinal Hernias

NCT00681291 | Completed Phase 4 Results

• 1 other identifier: LFC2007.04.01
• Study Type: interventional
• Target: 172
• Locations: 1 country
• Sites: 8

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.

Conditions

Hernia, Inguinal

Keywords

surgical mesh; inguinal hernia repair; chronic groin pain

Outcome Measures

Primary Outcomes (4)

• Change From Baseline in Activities Assessment Scale at 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.

  Baseline to 3 Months

• Change From Baseline in Activities Assessment Scale at 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.

  Baseline to 6 Months

• Change From Baseline in Activities Assessment Scale at 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.

  Baseline to 12 Months

• Change From Baseline in Activities Assessment Scale at 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.

  Baseline to 24 Months

Study Arms (2)

1

ACTIVE COMPARATOR

lightweight polypropylene mesh

Device: Inguinal hernia repair with Ultrapro

2

ACTIVE COMPARATOR

Strattice

Device: Inguinal hernia repair with Strattice

Interventions

Inguinal hernia repair with Ultrapro DEVICE

surgical mesh (15x15cm) to support Lichtenstein repair

Also known as: Ultrapro (Ethicon, Somerville NJ)

1

Inguinal hernia repair with Strattice DEVICE

Surgical mesh (10x16) used to support Lichtenstein repair

Also known as: Strattice Reconstructive Tissue Matrix

2

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• adult male
• symptomatic and palpable inguinal hernia
• open, elective, primary unilateral inguinal hernia repair

You may not qualify if:

• 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

Sponsors & Collaborators

• LifeCell: lead

Study Sites (8)

Hospital of St Raphael

New Haven, Connecticut, 06511, United States

Location

Tulane University Health Sciences Center

New Orleans, Louisiana, 70112, United States

Location

University of Maryland School of Medicine

Baltimore, Maryland, 21201, United States

Location

Creighton University

Omaha, Nebraska, 68178, United States

Location

Regional Surgical Associates

Durham, North Carolina, 27704, United States

Location

Oregon Health Sciences University

Portland, Oregon, 97239, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Sentara Norfolk General Hospital

Norfolk, Virginia, 23507, United States

Location

Related Publications (1)

• 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.

  PMID: 21222008 DERIVED

MeSH Terms

Conditions

Hernia, Inguinal

Condition Hierarchy (Ancestors)

Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Donna Jacobs
• Organization: LifeCell

djacobs@lifecell.com

908-809-7856

Study Officials

• Charles Bellows, MD, FACS

  Tulane University

  PRINCIPAL INVESTIGATOR

• Samir Awad, MD, FACS

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

• Robert Fitzgibbons, MD, FACS

  Creighton University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2008
• First Posted: May 21, 2008
• Study Start: April 1, 2008
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: May 10, 2016
• Results First Posted: March 23, 2016

Record last verified: 2016-04

Locations

US (8)