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 disinfection

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2005-005960-95-GB

Enrollment

676

Registered

2006-02-17

Start date

2006-04-26

Completion date

Unknown

Last updated

2019-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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.

Interventions

Product Name: Chloraprep Product Code: 260825, 260725, 260700, 260400 Pharmaceutical Form: Cutaneous solution INN or Proposed INN: 2% w/v chlorhexidine

Eligibility

Sex/Gender

All

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
Main Objective: Phase 1: To evaluate the reduction in bacterial numbers on the skin surface when Chloraprep® or 0.5% (w/v) chlorhexidine gluconate in 70% (v/v) isopropyl alcohol is used for pre-operative skin disinfection of the surgical site on the leg and post-operative wound care in patients undergoing coronary artery bypass grafting. Both the immediate and persistent antibacterial effects will be evaluated ;Secondary Objective: Phase 2: To compare leg surgical site infection rates when either Chloraprep® or 0.5% (w/v) chlorhexidine gluconate in 70% (v/v) isopropyl alcohol is used for pre-operative skin antisepsis and post-operative incision site care in patients undergoing coronary artery bypass grafting.; Primary end point(s): Outcome measures phase 1: Comparing bacterial numbers on patients' skin following use of Chloraprep or 0.5% (w/v) chlorhexidine gluconate in 70% (v/v) isopropyl alcohol for disinfection. At least 100 patients (50 in the control group and 50 in the trial group) phase 1 and 2: Comparing rates of surgical site infection on the leg wound following use of Chloraprep or 0.5% (w/v) chlorhexidine gluconate in 70% (v/v) isopropyl alcohol for disinfection. At least 576 patients (288 in the control group and 288 in the trial group).	—

Measure

Time frame

Main Objective: Phase 1: To evaluate the reduction in bacterial numbers on the skin surface when Chloraprep® or 0.5% (w/v) chlorhexidine gluconate in 70% (v/v) isopropyl alcohol is used for pre-operative skin disinfection of the surgical site on the leg and post-operative wound care in patients undergoing coronary artery bypass grafting. Both the immediate and persistent antibacterial effects will be evaluated ;Secondary Objective: Phase 2: To compare leg surgical site infection rates when either Chloraprep® or 0.5% (w/v) chlorhexidine gluconate in 70% (v/v) isopropyl alcohol is used for pre-operative skin antisepsis and post-operative incision site care in patients undergoing coronary artery bypass grafting.; Primary end point(s): Outcome measures phase 1: Comparing bacterial numbers on patients' skin following use of Chloraprep or 0.5% (w/v) chlorhexidine gluconate in 70% (v/v) isopropyl alcohol for disinfection. At least 100 patients (50 in the control group and 50 in the trial group) phase 1 and 2: Comparing rates of surgical site infection on the leg wound following use of Chloraprep or 0.5% (w/v) chlorhexidine gluconate in 70% (v/v) isopropyl alcohol for disinfection. At least 576 patients (288 in the control group and 288 in the trial group).

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Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026