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

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ClinicalTrials.gov Identifier: NCT00940446
Recruitment Status : Completed
First Posted : July 16, 2009
Results First Posted : January 30, 2018
Last Update Posted : January 30, 2018
Information provided by (Responsible Party):
Orthopaedic Research Foundation

July 14, 2009
July 16, 2009
April 3, 2017
January 30, 2018
January 30, 2018
July 2007
April 30, 2010   (Final data collection date for primary outcome measure)
Participants With Incisional Drainage, Swelling or Gaps of Incision [ Time Frame: Discharge from initial hospital stay (2-5 days post-op) ]
Incisional drainage, swelling, gaps of incision. Drainage and swelling will be objectively determined by investigator. Gaps will be measured in millimeters.
Appearance [ Time Frame: Dishcarge, 2 weeks & 6 weeks ]
Complete list of historical versions of study NCT00940446 on ClinicalTrials.gov Archive Site
Participants With Wound Complications - Hematoma [ Time Frame: up to 6 weeks post-op ]
Assessment of wound for complications, especially hematomas at 6 weeks post surgery. Participants will be scored based on presence of a hematoma or not.
Photographs, CRF [ Time Frame: Discharge, 2 weeks & 6 weeks ]
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.
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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.
April 30, 2010
April 30, 2010   (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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
Not Provided
Not Provided
Orthopaedic Research Foundation
Orthopaedic Research Foundation
Principal Investigator: David A Fisher, MD Indiana Orthopaedic Hospital
Orthopaedic Research Foundation
January 2018

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