Efficacy of InteguSeal for Surgical Skin Preparation in Patients Undergoing Total Joint Replacement
Completed · Not applicable
Conditions studied: Prosthetic Joint Infection, Surgical Skin Infection
In brief
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 patients undergoing total hip replacement (THA) or total knee replacement (TKA). Integuseal is supposed to lock down the skin bacteria and reduce skin infection and other problems. This study will investigate whether Integuseal is effective in reducing persistent wound drainage when used in addition to standard surgical skin preparation for total hip arthroplasty (THA) or total knee replacement (TKA).
Key facts
- Study ID
- NCT00829556
- Run by
- Rothman Institute Orthopaedics
- People needed
- 160
- Starts
- 2008-04-01
- Expected to finish
- 2009-09-01
- Last updated by the study team
- 2009-12-21
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- Rothman Institute — Philadelphia, Pennsylvania, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.