Antimicrobial Activity of IV Clear™ Dressing - Prevention of Antimicrobial Regrowth

Covalon Technologies

Status and phase

Completed

Phase 1

Conditions

Skin Flora Infection

Treatments

Device: Silicone Vehicle Control Dressing

Device: Tegaderm CHG™

Device: IV Clear™ Dressing

Study type

Interventional

Funder types

Industry

Identifiers

NCT01368120

TP-014

Details and patient eligibility

About

The purpose of this study is to assess the surface cutaneous antimicrobial activity of IV Clear™ Dressing, Tegaderm CHG™ Dressing and a Silicone Vehicle Control Dressing.

Full description

A single center, within-subject randomized study design in healthy adult subjects with a history of high bacteria counts on their upper back, meeting the inclusion criteria.

Antimicrobial efficacy will be measured by determining the mean number of Colony Forming Units (CFUs) per square centimetre (cm²) of skin prior to treatment (baseline measurement), following preparation with 70% isopropyl alcohol, and following post treatment samples.

The goal of this study is to demonstrate that IV Clear™ is as effective as or better than Tegaderm™ CHG dressing in preventing regrowth of cutaneous microbial flora on test subjects.

Enrollment

37 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Are ≥ 18 years of age and ≤ 65 years of age
Are in good health, as evidenced by response to the demographics/dermatological medical history form
Are willing to refrain from using antimicrobial soaps for bathing and showering during the entire study
Are willing to refrain from swimming in chemically treated pool or hot tub for duration of study
Are willing to refrain from using antimicrobial/medicated lotions and creams for duration of study, unless prescribed by a physician for an intercurrent illness
Are willing to refrain from using topical or systemic antibiotic medication for duration of study, unless prescribed by a physician for an intercurrent illness
Are willing to refrain from use of body powders and fabric softeners
Are willing to use soap and shampoo and antiperspirant/deodorant provided exclusively during study
Have qualification screening bacterial counts of ≥ 2.5 log10 CFU/cm² on two contralateral sites on the upper back
Are willing to comply with all study protocol requirements

Exclusion criteria

Subjects will not be enrolled in the study if they:

Are currently pregnant or lactating
Have been exposed to topical or systemic antimicrobials during two weeks proceeding treatment. This restriction will include, but is not limited to shampoos, lotions, soaps, body powders, and materials such as solvents, acids, or alkalis
Have known soap, detergent, antibiotic and/or perfume allergies
Have been medically diagnosed as having a medical condition that precludes participation, such as: diabetes, hepatitis, an organ transplant, a medical surgical implant or an immune compromised system
Have any medical condition which in the opinion of the Investigator prelude participation
Have swam in chemically treated pools or hot tubs two weeks prior to any microbial sampling
Have used UV tanning lamps two weeks prior to any microbial sampling
Have tattoos, dermatoses, abrasions, cuts, lesions or other skin disorders on test sites
Have bathed or showered less than 48 hours prior to any microbial sampling
Have known sensitivity to adhesive products, or to materials used in test articles
Have participated in any type of back wash study within 7 days prior to study
Have a known sensitivity to latex products
Are not willing to fulfill the requirements of the protocol