Status:
COMPLETED
Efficacy of InteguSeal for Surgical Skin Preparation in Patients Undergoing Total Joint Replacement
Lead Sponsor:
Rothman Institute Orthopaedics
Collaborating Sponsors:
Kimberly-Clark Corporation
Conditions:
Prosthetic Joint Infection
Surgical Skin Infection
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
This study is being conducted to investigate the potential benefits of using a special type of fluid that can be applied to the skin (Integuseal) in addition to standard surgical skin preparation in p...
Eligibility Criteria
Inclusion
- Subjects who are able and willing to provide informed consent;
- Male and non-pregnant, non-lactating, female subjects who are willing to practice effective means of contraception or postmenopausal/surgically sterilized female subjects, between the ages of 18-80 years old, of any ethnic origin.
- Subjects deemed able to comply with study schedule visits, procedures and medications as specified by the protocol.
- Subjects undergoing elective THA or TKA procedures.
- Subjects in satisfactory health as determined by the investigator on the basis of medical history and physical examination.
Exclusion
- Subjects undergoing revision, hemiarthroplasty, or bilateral THA or TKA
- Subjects undergoing non-elective THA or TKA procedures.
- Pregnant or lactating females or females of childbearing potential not practicing an effective method of contraception.
- Subjects with known allergies to iodine and/or chlorhexidine
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2009
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT00829556
Start Date
April 1 2008
End Date
September 1 2009
Last Update
December 21 2009
Active Locations (1)
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1
Rothman Institute
Philadelphia, Pennsylvania, United States, 19107