Prospective, randomised clinical trial to compare the efficacy of 0.5% (w/v) chlorhexidine gluconate in 70% (v/v) isopropyl alcohol with 2% (w/v) chlorhexidine gluconate in 70% (v/v) isopropyl alcohol (Chloraprep) for the pre-operative disinfection of skin prior to coronary artery bypass grafting and post operative wound care. - Evaluation of Chloraprep for skin disinfectio
Phase 1
- Conditions
- This product is a skin disinfectant and therefore is not specific for a medicinal condition. It will be used where patients require skin disinfection prior to surgery and for care of the surgical wound.
- Registration Number
- EUCTR2005-005960-95-GB
- Lead Sponsor
- Enturia, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 676
Inclusion Criteria
•Must be at least 18 years of age.
•Require coronary artery bypass grafting
•Donor vein retrieval from the leg (saphenous veins)
•Willing and able to provide informed consent.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
•Psychiatric history or mental handicap
•Breast feeding females or pregnancy
•Patients with a known history of chlorhexidine allergy
•Patients with dermatoses, inflammation or injuries to the donor site.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method