Conditions: Surgery
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 249
Healthy volunteers: yes

Brief summary:
Evaluating the irritation properties of CHG cloth. Some Subjects will also have the product applied to see if they become sensitized to repeated applications.

Detailed description:
For the Irritation Study (30 subjects), patches containing CHG, vehicle, saline, CHG comparator or sodium lauryl sulfate (a product that is expected to produce a slight skin irritation) will be placed on the same spot of your skin every day for 21 days. The skin will be examined every day.

The Sensitization Study (200 total subjects) place patches containing CHG, vehicle, saline, CHG comparator on the skin 3 times a week for 3 weeks. Following a two-week rest period the patches will be reapplied for 48 hours and assessed out to 72 hours thereafter.

Arms:
arm 1: Chlorhexidine Gluconate 2% arm 2: Excipients on cloth arm 3: Chlorhexidine Gluconate 2% solution arm 4: 0.9% sodium chloride arm 5: Sodium lauryl sulfate to produce mild irritation as a positive control

Interventions: intervention 1: 2% CHG Cloth solution intervention 2: Vehicle Cloth intervention 3: Active Comparator intervention 4: Saline intervention 5: SLS
Intervention descriptions: intervention 1: Investigational CHG intervention 2: Excipients from CHG cloth only intervention 3: Active comparator intervention 4: Negative control intervention 5: Provides a slight irritation for a positive control

Protocol document: