Evaluation of Chlorhexidine Gluconate Concentration on Skin of Human Subjects Following Multiple Application Times

NCT ID: NCT04235985

Last Updated: 2020-08-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-23
• Study Completion Date: 2020-04-02

Brief Summary

This study will evaluate the amount of chlorhexidine gluconate (CHG) present on treated skin of human volunteers following different application times with a test material bathing system. The amount of recovered CHG that resides on the skin following each of the evaluated application times will be evaluated via high performance liquid chromatography with ultraviolet detection (HPLC-UV) and correlated with the MIC values determined separately.

Conditions

General Skin Cleansing

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

All time points

Group Type: OTHER

Chlorhexidine Gluconate with HUBS

Intervention Type: COMBINATION_PRODUCT

4% CHG soap will be applied to HUBS following manufacturers recommendation and applied to skin for different application times as dictated by the randomization of the marked sites on the forearm. Followed by a HUBS moistened with water.

Interventions

Chlorhexidine Gluconate with HUBS

4% CHG soap will be applied to HUBS following manufacturers recommendation and applied to skin for different application times as dictated by the randomization of the marked sites on the forearm. Followed by a HUBS moistened with water.

Intervention Type: COMBINATION_PRODUCT

Eligibility Criteria

Inclusion Criteria

• Subjects must be at least 18 years of age and can be of either sex and of any race.
• Subjects must be able to read and understand English.
• Subjects must possess both forearms and have a minimum forearm length (wrist crease to elbow crease) of 8.25 inches [21 cm].
• Subjects must be in good general health (i.e., no current or recent severe illness) and have no medical diagnosis of mitral valve prolapse with heart murmur, congenital heart disease, an organ transplant, medicated or uncontrolled diabetes, hepatitis B or C, an immunocompromised condition such as AIDS (or HIV positive), lupus, fibromyalgia, ulcerative colitis, Crohn's disease, moderate to severe asthma (requiring daily use of medication), or medicated multiple sclerosis.

Exclusion Criteria

• Participation in a clinical study within 7 days of participating in this study or current participation in another clinical study.
• Presence of tattoos, active skin rashes, dermatoses, or breaks in the skin of the forearms or hands. Subjects must also have no inflammatory skin conditions (such as atopic dermatitis / eczema, contact dermatitis, or psoriasis) anywhere on the body.
• Known allergies or sensitivities to latex (natural rubber), alcohols, sunscreens, deodorants, laundry detergents, inks, metals, topically-applied fragrances (e.g., colognes or perfumes), cleansers, soaps, lotions, or to common antibacterial agents particularly chlorhexidine gluconate (CHG).
• Have experienced hives (raised welts) as a reaction to anything that contacted the skin, with the exception of plants known to cause reactions for most humans (e.g., poison oak or poison ivy).
• Have a history of anaphylactic shock, anaphylactoid reaction, or anaphylactoid shock.
• Any prosthetic device or joint (e.g., pins, screws, plates, or rods) installed in the arms within the last 6 months.
• Any type of indwelling port or Peripherally-Inserted Central Catheter (PICC).
• Subject is pregnant, plans to become pregnant or impregnate a sexual partner within the pre-test and test periods of the study, or is nursing a child.
• Any medical condition or use of any medications that, in the opinion of the Principal Investigator or Consulting Physicians, should preclude participation.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Molnlycke Health Care AB

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Russell Griggs

Role: PRINCIPAL_INVESTIGATOR

BSLI

Locations

Bioscience Laboratories, Inc

Bozeman, Montana, United States

Countries

United States

Other Identifiers

#1906236-150B

Identifier Type: -

Identifier Source: org_study_id