Text Size

A Comparison of INSORB Staples With Metal Staples in Total Hip Replacement

This study has been completed.
Sponsor:
Collaborator:
OrthoIndy
Information provided by (Responsible Party):
Orthopaedic Research Foundation
ClinicalTrials.gov Identifier:
NCT00940446
First received: July 14, 2009
Last updated: November 8, 2012
Last verified: November 2012
History of Changes
  Purpose

The purpose of this study is to compare the use of INSORB absorbable staples with metal staples on surgical incision healing after total hip replacement. The study evaluates wound healing, complications, and patient satisfaction regarding wound comfort and appearance after surgery.


Condition Intervention Phase
Erythema
Drainage
Bruising
Pain
 Device: Insorb staples
Device: metal staples (Ethicon metal stapler)
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: A Comparison of INSORB Staples With Metal Staples in Total Hip Replacement

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Orthopaedic Research Foundation:

Primary Outcome Measures:
  • Appearance [ Time Frame: Dishcarge, 2 weeks & 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Photographs, CRF [ Time Frame: Discharge, 2 weeks & 6 weeks ] [ Designated as safety issue: No ]

Enrollment: 60
Study Start Date: July 2007
Study Completion Date: July 2009
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Insorb staples
Subcuticular Absorbable staples
 Device: Insorb staples
absorbable staples required for wound closure
Other Names:
  • Insorb absorbable stapler
  • GDW
Active Comparator: Control
Metal staple wound closure
 Device: metal staples (Ethicon metal stapler)
wound closure with metal staples
Other Name: Ethicon metal stapler

Detailed Description:

Subcuticular closure of wounds can provide superior results to percutaneous suture closure due to the elimination of suture or staple tracts. These tracts can lead to infection and migration of epithelial cells adding to scarring, and cross-hatching scars which remain after healing. Absorbable staples can provide a rapid, secure, subcuticular closure of skin as an alternative to the traditional, manual staple or suture closure. This study will compare INSORB absorbable staples to externally applied standard metal staples with respect to effectiveness of incision closure, acute healing, subject comfort level, security and appearance after total hip replacement.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patient is 18 years or older
  • Patient or legal representative is able to understand and provide signed consent for the procedure
  • Patient is willing and able to return for required follow-up visits
  • Patient needs a total hip arthroplasty surgical procedure

Exclusion Criteria:

  • Patient has an active infection
  • Patient is enrolled in another similar study
  • Patient has a known history of hepatitis
  • Patient has a known history of HIV
  • Patient has a known history of AIDs
  • Patient has a known history of IV drug abuse
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00940446

Locations
United States, Indiana
Indiana Orthopaedic Hospital
Indianapolis, Indiana, United States, 46278
Sponsors and Collaborators
Orthopaedic Research Foundation
OrthoIndy
Investigators
Principal Investigator: David A Fisher, MD Indiana Orthopaedic Hospital
  More Information

No publications provided

Responsible Party: Orthopaedic Research Foundation
ClinicalTrials.gov Identifier: NCT00940446     History of Changes
Other Study ID Numbers: DAF_PC000001
Study First Received: July 14, 2009
Last Updated: November 8, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Orthopaedic Research Foundation:
Insorb staples
Metal Staples

Additional relevant MeSH terms:
Contusions
Erythema
Wounds and Injuries
Wounds, Nonpenetrating
Skin Diseases

ClinicalTrials.gov processed this record on June 18, 2013