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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

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.

Condition or disease Intervention/treatment Phase
Erythema Drainage Bruising Pain Device: Insorb staples Device: metal staples (Ethicon metal stapler) Not Applicable

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 : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: A Comparison of INSORB Staples With Metal Staples in Total Hip Replacement
Study Start Date : July 2007
Actual Primary Completion Date : April 30, 2010
Actual Study Completion Date : April 30, 2010

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Orthopaedic Research Foundation
ClinicalTrials.gov Identifier: NCT00940446     History of Changes
Other Study ID Numbers: DAF_PC000001
First Posted: July 16, 2009    Key Record Dates
Results First Posted: January 30, 2018
Last Update Posted: January 30, 2018
Last Verified: January 2018

Keywords provided by Orthopaedic Research Foundation:
Insorb staples
Metal Staples

Additional relevant MeSH terms:
Erythema
Skin Diseases