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

July 14, 2009
November 8, 2012
July 2007
November 2008   (final data collection date for primary outcome measure)
Appearance [ Time Frame: Dishcarge, 2 weeks & 6 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00940446 on ClinicalTrials.gov Archive Site
Photographs, CRF [ Time Frame: Discharge, 2 weeks & 6 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Comparison of INSORB Staples With Metal Staples in Total Hip Replacement
A Comparison of INSORB Staples With Metal Staples in Total Hip Replacement

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
  • Erythema
  • Drainage
  • Bruising
  • Pain
  • Device: Insorb staples
    absorbable staples required for wound closure
    Other Names:
    • Insorb absorbable stapler
    • GDW
  • Device: metal staples (Ethicon metal stapler)
    wound closure with metal staples
    Other Name: Ethicon metal stapler
  • Experimental: Insorb staples
    Subcuticular Absorbable staples
    Intervention: Device: Insorb staples
  • Active Comparator: Control
    Metal staple wound closure
    Intervention: Device: metal staples (Ethicon metal stapler)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
July 2009
November 2008   (final data collection date for primary outcome measure)

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
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00940446
DAF_PC000001
Yes
Orthopaedic Research Foundation
Orthopaedic Research Foundation
OrthoIndy
Principal Investigator: David A Fisher, MD Indiana Orthopaedic Hospital
Orthopaedic Research Foundation
November 2012

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