Preoperative CHG Cloth on Healthy Subjects

Medline Industries

Status and phase: Completed; Phase 3

Conditions: Surgery

Treatments: Drug: Chlorhexidine Gluconate; Drug: DynaHex-2; Other: Vehicle

Study type: Interventional

Funder types: Industry

Identifiers

NCT02291601

R13-052

Details and patient eligibility

About

Evaluate the effects of CHG cloth on the reduction of bacteria on the skin.

Full description

Examine the antimicrobial cloth effects on normal flora bacteria of the abdomen and groin area post CHG application.

Enrollment: 879 patients

Sex: All

Ages: 16+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Males or Females
• 16 years of age or older
• Signed informed consent
• Good Health
• Six inches of abdomen and groin areas without tattoos, or skin disorders

Exclusion criteria

• Dermatological Conditions
• Sensitivity to latex
• Sensitivity to CHG

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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879 participants in 3 patient groups, including a placebo group

Chlorhexidine Gluconate Cloth

Experimental group

Description:

2% CHG, single application

Treatment:

Drug: Chlorhexidine Gluconate

Vehicle Cloth

Placebo Comparator group

Description:

Excipients on cloth

Treatment:

Other: Vehicle

Active Chlorhexidine gluconate solution

Active Comparator group

Description:

Dynahex 2% CHG

Treatment:

Drug: DynaHex-2