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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
Sponsor:
Collaborator:
OrthoIndy
Information provided by (Responsible Party):
Orthopaedic Research Foundation

Tracking Information
First Submitted Date  ICMJE July 14, 2009
First Posted Date  ICMJE July 16, 2009
Results First Submitted Date  ICMJE April 3, 2017
Results First Posted Date  ICMJE January 30, 2018
Last Update Posted Date January 30, 2018
Study Start Date  ICMJE July 2007
Actual Primary Completion Date April 30, 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 4, 2018)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: July 15, 2009)
Appearance [ Time Frame: Dishcarge, 2 weeks & 6 weeks ]
Change History Complete list of historical versions of study NCT00940446 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 4, 2018)
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.
Original Secondary Outcome Measures  ICMJE
 (submitted: July 15, 2009)
Photographs, CRF [ Time Frame: Discharge, 2 weeks & 6 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Comparison of INSORB Staples With Metal Staples in Total Hip Replacement
Official Title  ICMJE A Comparison of INSORB Staples With Metal Staples in Total Hip Replacement
Brief Summary 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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE
  • Erythema
  • Drainage
  • Bruising
  • Pain
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: Insorb staples
    Subcuticular Absorbable staples
    Intervention: Device: Insorb staples
  • Active Comparator: Control
    Metal staple wound closure
    Intervention: Device: metal staples (Ethicon metal stapler)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 15, 2009)
60
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 30, 2010
Actual Primary Completion Date April 30, 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00940446
Other Study ID Numbers  ICMJE DAF_PC000001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Orthopaedic Research Foundation
Study Sponsor  ICMJE Orthopaedic Research Foundation
Collaborators  ICMJE OrthoIndy
Investigators  ICMJE
Principal Investigator: David A Fisher, MD Indiana Orthopaedic Hospital
PRS Account Orthopaedic Research Foundation
Verification Date January 2018

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