Irritation and Sensitization of Chlorhexidine Gluconate (CHG) Cloth

Medline Industries

Status and phase: Completed; Phase 3

Conditions: Surgery

Treatments: Drug: 2% CHG Cloth solution; Device: Vehicle Cloth; Drug: Active Comparator; Other: SLS; Other: Saline

Study type: Interventional

Funder types: Industry

Identifiers

NCT02224625

R13-051

Details and patient eligibility

About

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

Full 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.

Enrollment: 249 patients

Sex: All

Ages: 16+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Free of skin disorders
• Signed consent

Exclusion criteria

• Allergies to latex
• Topical or systemic steroids, antihistamines, antiinflammatory agents 7 days prior or during testing
• severe illness
• Pregnant (females)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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249 participants in 5 patient groups, including a placebo group

2% CHG Cloth

Experimental group

Description:

Chlorhexidine Gluconate 2%

Treatment:

Drug: 2% CHG Cloth solution

Vehicle Cloth

Placebo Comparator group

Description:

Excipients on cloth

Treatment:

Device: Vehicle Cloth

DynaHex (2% CHG)

Active Comparator group

Description:

Chlorhexidine Gluconate 2% solution

Treatment:

Drug: Active Comparator

Saline

Sham Comparator group

Description:

0.9% sodium chloride

Treatment:

Other: Saline

Sodium Lauryl Sulfate (SLS)

Active Comparator group

Description:

Sodium lauryl sulfate to produce mild irritation as a positive control

Treatment:

Other: SLS