Clinical trial NCT03681990: In Vivo Preoperative Skin Preparation Efficacy Study Within a Defined Product Coverage Area
Official title: Evaluation of Microbial Population Reductions Within a Defined Product Coverage Area
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Surgical Skin Preparation
Surgical Procedure, Unspecified
Keywords: surgical skin prep
CHG
IPA
Lead sponsor: Solventum US LLC
Sponsor class: INDUSTRY
Collaborators: name: 3M
First posted: 2018-09-24
Enrollment: 28
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This study evaluates reduction of resident flora produced by the test product within a defined prepped area of skin.

Detailed description: Three different sample sites within a defined prepped area of skin were collected to determine whether reductions in resident flora produced by the test product are consistent.

Eligibility criteria: Inclusion Criteria:

* Male subjects of any race who are at least 18 years of age,
* Subjects must have an area on their back region to accommodate the treatment coverage area,
* Subjects must be in good general health,
* Subjects who satisfy all inclusion/exclusion criteria and will voluntarily read and sign the Informed Consent Form,
* Subjects who have good skin condition on the test sites,
* Subjects who are willing to report to the study facility approximately 72 hours prior to Screening or Treatment Day for clipping, if needed,
* Subjects who are willing to avoid showering and tub-bathing within 72 hours prior to Screening and Treatment Days, and
* Subjects who have Screening Day baseline counts of \> 3.00 log10 per cm2 in each of the 3 sample sites (center, mid-peripheral and peripheral) in the treatment area (back region).

Exclusion Criteria:

* Participation in another clinical study in the past 30 days, current participation in another clinical study, or previous participation in this study,
* Has taken antihistamines in the 48 hours prior to Treatment Day,
* Any tattoos, scars, breaks in the skin, or any form of dermatitis, or other skin disorders (including acne) on the applicable test areas,
* A history of skin allergies,
* A history of skin cancer within 6 inches of the test areas,
* Known sensitivity to acrylate-, chlorhexidine gluconate-, or alcohol-containing products, or to medical tape, metals, natural rubber latex, vinyl, or skin-marking inks,
* A medical diagnosis with physical condition that may put the subject at risk, such as a current or recent severe illness, hepatitis, organ transplant, congestive heart disease, or any immunocompromised conditions, such as AIDS (or HIV positive),
* Any medical condition or use of any medications that, in the opinion of the Investigator, should preclude participation,
* Topical antimicrobial exposure within 14 days prior to Screening Day and throughout the study. Restrictions include, but are not limited to antimicrobial soaps, medicated shampoos, medicated lotions, antiperspirants/deodorants, perfumes, after shaves, and colognes,
* Use of systemic or topical antibiotic medications, steroid medications, or any other product known to affect the normal microbial flora of the skin within 14 days prior to Screening Day and throughout the study,
* Exposure of the test areas to solvents, acids, bases, strong detergents, fabric softener-treated clothing, or other household chemicals within 14 days prior to Screening Day and throughout the study,
* Swimming in chemically treated pools or bathing in hot tubs, spas, or whirlpools within 14 days prior to Screening Day and throughout the study,
* Use of tanning beds, hot waxes, or depilatories (in the applicable test areas) within 14 days prior to Screening Day and throughout the study
* Bathing and showering within 72 hours prior to Screening Day and throughout the study, or
* Subject has used moisturizers or any topical treatment (e.g. lotion, sunscreen or shaving cream) on the test sites in the 24-hour period prior to Screening Day and Treatment Day participation in the study.

Primary outcomes:
measure: Comparison of Log Change of Skin Flora Relative to Pre-treatment (Baseline) in Each of 3 Sampling Sites at a Defined Post-treatment Sampling Time.
timeFrame: Post-treatment sampling randomized as 10-minute or 13-minute post-product application
Secondary outcomes:
Other outcomes:
measure: Safety Outcome Evaluated by Skin Irritation Assessment
timeFrame: Assessed pre-treatment (baseline) and post-treatment (10 or 13 minutes)
Locations:
city: Bucharest
country: Romania
facility: Eurofins Evic Romania/S.C. BIO HIGH TECH S.R.L.
Study officials:
affiliation: Eurofins/Evic
name: Rozalia Olsavszky, MD
role: PRINCIPAL_INVESTIGATOR
References: