A Comparison of INSORB Staples With Metal Staples in Total Hip Replacement
Primary Purpose
Erythema, Drainage, Bruising
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Insorb staples
metal staples (Ethicon metal stapler)
Sponsored by
About this trial
This is an interventional health services research trial for Erythema focused on measuring Insorb staples, Metal Staples
Eligibility 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
Sites / Locations
- Indiana Orthopaedic Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Insorb staples
Control
Arm Description
Subcuticular Absorbable staples
Metal staple wound closure
Outcomes
Primary Outcome Measures
Participants With Incisional Drainage, Swelling or Gaps of Incision
Incisional drainage, swelling, gaps of incision. Drainage and swelling will be objectively determined by investigator. Gaps will be measured in millimeters.
Secondary Outcome Measures
Participants With Wound Complications - Hematoma
Assessment of wound for complications, especially hematomas at 6 weeks post surgery. Participants will be scored based on presence of a hematoma or not.
Full Information
NCT ID
NCT00940446
First Posted
July 14, 2009
Last Updated
January 4, 2018
Sponsor
Orthopaedic Research Foundation
Collaborators
OrthoIndy
1. Study Identification
Unique Protocol Identification Number
NCT00940446
Brief Title
A Comparison of INSORB Staples With Metal Staples in Total Hip Replacement
Official Title
A Comparison of INSORB Staples With Metal Staples in Total Hip Replacement
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
July 2007 (undefined)
Primary Completion Date
April 30, 2010 (Actual)
Study Completion Date
April 30, 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Orthopaedic Research Foundation
Collaborators
OrthoIndy
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Erythema, Drainage, Bruising, Pain
Keywords
Insorb staples, Metal Staples
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Insorb staples
Arm Type
Experimental
Arm Description
Subcuticular Absorbable staples
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Metal staple wound closure
Intervention Type
Device
Intervention Name(s)
Insorb staples
Other Intervention Name(s)
Insorb absorbable stapler, GDW
Intervention Description
absorbable staples required for wound closure
Intervention Type
Device
Intervention Name(s)
metal staples (Ethicon metal stapler)
Other Intervention Name(s)
Ethicon metal stapler
Intervention Description
wound closure with metal staples
Primary Outcome Measure Information:
Title
Participants With Incisional Drainage, Swelling or Gaps of Incision
Description
Incisional drainage, swelling, gaps of incision. Drainage and swelling will be objectively determined by investigator. Gaps will be measured in millimeters.
Time Frame
Discharge from initial hospital stay (2-5 days post-op)
Secondary Outcome Measure Information:
Title
Participants With Wound Complications - Hematoma
Description
Assessment of wound for complications, especially hematomas at 6 weeks post surgery. Participants will be scored based on presence of a hematoma or not.
Time Frame
up to 6 weeks post-op
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David A Fisher, MD
Organizational Affiliation
Indiana Orthopaedic Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Indiana Orthopaedic Hospital
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46278
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Comparison of INSORB Staples With Metal Staples in Total Hip Replacement
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