Single Dose CHG Pharmacokinetic Study

Medline Industries

Status and phase: Completed; Phase 1

Conditions: Surgical Skin Preparation

Treatments: Drug: Chlorhexidine Gluconate

Study type: Interventional

Funder types: Industry

Identifiers

NCT03331263

R17-023

Details and patient eligibility

About

A single 2% topical application of ReadyPrep® CHG was applied on either the abdomen (Treatment-1) or the groin (Treatment-2) whereas Treatment-3 consisted of a control treatment where the same procedure as Treatment-1 and -2 was performed, but without the topical application of ReadyPrep® CHG. The treatments were separated by a wash-out of 7 calendar days.

Enrollment: 12 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Subjects were male or female, aged ≥ 18 and ≤ 60 years (inclusive). The main inclusion criteria were:

  • non- or ex-smokers
  • body mass index (BMI) ≥19.00 kg/m2 and ≤32.00 kg/m2 and a body weight ≥ 55 kg
  • negative pregnancy test for female subjects
  • healthy according to medical history, complete physical examination (including vital signs and skin examination) and laboratory tests (general biochemistry, hematology and urinalysis)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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12 participants in 3 patient groups

Abdominal application of 2% CHG

Experimental group

Treatment:

Drug: Chlorhexidine Gluconate

Groin application of 2% CHG

Experimental group

Treatment:

Drug: Chlorhexidine Gluconate

Control treatment with no application

No Intervention group