Preoperative Skin Preparation
Conditions
Brief summary
Healthy volunteers will receive treatment to two body locations with the investigational product and placebo and the antimicrobial effectiveness of each treatment will be measured.
Interventions
DRUGOctenidine Dihydrocloride in aqueous solution
application of investigational product
OTHERVehicle Control
application of vehicle control
OTHERSaline Control
application of placebo
Sponsors
Becton, Dickinson and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Males and/or females, at least 18 years or older and of any race. * Are in good general health. * Unable to become pregnant, or willing to use an acceptable method of contraception (i.e. oral contraception, intra-uterine device \[IUD\], diaphragm, condom, abstinence, bilateral Tubal ligation, or are in a monogamous relationship with a partner who has had a Vasectomy) to prevent pregnancy for at least 14 days immediately preceding Treatment Day and throughout the duration of the study, if female of child-bearing potential. * All female subjects must have a negative urine pregnancy test on Treatment Day prior to any applications of the study products. * Have skin within 6 inches of the test sites that is free of dermatoses, abrasions, cuts, lesions or other skin disorders. * Cooperative and willing to follow Subject Instructions * Cooperative and willing to sign Consent Form and HIPAA Authorization Form. * Able to read, write and follow instructions in English.
Exclusion criteria
* Exposure to topical or systemic antimicrobials or any other product known to affect the normal microbial flora of the skin, antibiotics or steroids (other than hormones for contraception or post-menopausal reasons) exposure within 14 days prior to Treatment Day and for the remainder of the study. Restrictions include, but are not limited to antimicrobial-containing soaps, antiperspirants/deodorants, shampoos, lotions, perfumes, after shaves, and colognes. * Swimming in chemically treated pools or bathing in hot tubs, spas and whirlpools within 14 days prior to Treatment Day and for the remainder of the study. * Use of tanning beds, hot waxes, or depilatories, including shaving (in the applicable test areas) within 14 days prior to Treatment Day and for the remainder of the study. * Contact with strong detergents, solvents, acids, bases, bug repellant, fabric softener-treated clothing, UV treated clothing or other household chemicals in the applicable test areas within 14 days of the Treatment Day and for the remainder of the study. * Subjects who have a history of sensitivity to vinyl, natural rubber latex, adhesive skin products (e.g., Band-Aids, medical tapes), polyester, metals, inks, common antibacterial agents found in common personal beauty or personal care soaps, lotions, or ointments * Subjects who have asthma requiring medication, diabetes, hepatitis B or C, an organ transplant, mitral valve prolapse with a heart murmur, congenital heart disease, lupus, Crohn's disease, medicated multiple sclerosis, internal prosthesis or any immunocompromised conditions (such as AIDS or HIV positive). * Subjects who have a history of skin allergies. * Subjects who have a history of skin cancer within 6 inches of the applicable test areas or have received treatment for any type of internal cancer within the 5 years prior to enrollment. * Any tattoos or scars on the test sites or within 2 inches of the test sites; skin blemishes or warts may be permissible with the specific approval of the Principal Investigator or consulting physician. * Dermatoses, cuts, lesions, active skin rashes, scabs, breaks in the skin or other skin disorders within 6 inches on or around the test sites. * A currently active skin disease or inflammatory skin condition (for example contact dermatitis; psoriasis, and eczema) anywhere on the body. * Subjects who are pregnant, attempting pregnancy, or nursing. * Subjects who have showered or bathed within at least 72 hours of the Treatment Day (sponge baths may be taken, however, the lower abdomen and upper thigh region must be avoided). * Subjects who receive an irritation score of 1 (any redness, swelling, rash, or dryness present at any treatment area) for any individual skin condition prior to the Treatment Day baseline sample collection. * Participation in another clinical trial in the 30 days prior to signing the informed consent for this study, current enrollment in another clinical trial, or have already participated in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Bacterial Count at 10 Minutes Post Application | 10 minutes after application of test product |
Countries
United States
Participant flow
Pre-assignment details
Participants were only treated if baseline bacterial counts met the inclusion criteria. Participants were treated with 2 of 3 study products (Investigational Product, saline control, vehicle control) 1 on the left side of the body (both groin and abdomen), 1 on the right side of the body (both groin and abdomen). Therefore, treatment groups are not discrete categories.
Participants by arm
| Arm | Count |
|---|---|
| Participants Treated Participants who received study product at at least 1 treatment site (abdomen and/or groin). Participants were treated with 2 of 3 study products, investigational product (IP), saline control (SC), and/or vehicle control (VC). Therefore, treatments arms are not discrete groups of participants. Therefore, baseline data are presented for all treated participants and not by treatment arm. | 69 |
| Total | 69 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Screen Failure | 30 |
Baseline characteristics
| Characteristic | Participants Treated |
|---|---|
| Age, Continuous | 41 years STANDARD_DEVIATION 17 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 63 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 4 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants |
| Race (NIH/OMB) White | 64 Participants |
| Region of Enrollment United States | 69 participants |
| Sex: Female, Male Female | 17 Participants |
| Sex: Female, Male Male | 52 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 69 |
| other Total, other adverse events | 0 / 69 |
| serious Total, serious adverse events | 0 / 69 |
Outcome results
Primary
Bacterial Count at 10 Minutes Post Application
Time frame: 10 minutes after application of test product
Population: Analysis only includes participants with required treatment day baseline bacterial counts at each anatomical site at baseline and non-missing data at 10 minutes.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Investigational Product | Bacterial Count at 10 Minutes Post Application | Abdomen- Baseline | 3.55 log10 CFU/cm^2 | Standard Deviation 0.4 |
| Investigational Product | Bacterial Count at 10 Minutes Post Application | Abdomen- 10 minutes | 1.19 log10 CFU/cm^2 | Standard Deviation 1.28 |
| Investigational Product | Bacterial Count at 10 Minutes Post Application | Groin- Baseline | 5.95 log10 CFU/cm^2 | Standard Deviation 0.6 |
| Investigational Product | Bacterial Count at 10 Minutes Post Application | Groin- 10 minutes | 2.98 log10 CFU/cm^2 | Standard Deviation 1.14 |
| Saline Control | Bacterial Count at 10 Minutes Post Application | Abdomen- 10 minutes | 2.64 log10 CFU/cm^2 | Standard Deviation 0.58 |
| Saline Control | Bacterial Count at 10 Minutes Post Application | Groin- Baseline | 6.07 log10 CFU/cm^2 | Standard Deviation 0.53 |
| Saline Control | Bacterial Count at 10 Minutes Post Application | Abdomen- Baseline | 3.61 log10 CFU/cm^2 | Standard Deviation 0.41 |
| Saline Control | Bacterial Count at 10 Minutes Post Application | Groin- 10 minutes | 4.90 log10 CFU/cm^2 | Standard Deviation 0.56 |
| Vehicle Control | Bacterial Count at 10 Minutes Post Application | Groin- Baseline | 5.89 log10 CFU/cm^2 | Standard Deviation 0.47 |
| Vehicle Control | Bacterial Count at 10 Minutes Post Application | Abdomen- 10 minutes | 2.56 log10 CFU/cm^2 | Standard Deviation 0.97 |
| Vehicle Control | Bacterial Count at 10 Minutes Post Application | Groin- 10 minutes | 4.25 log10 CFU/cm^2 | Standard Deviation 0.68 |
| Vehicle Control | Bacterial Count at 10 Minutes Post Application | Abdomen- Baseline | 3.66 log10 CFU/cm^2 | Standard Deviation 0.4 |
Comparison: Test on abdomen Average treatment effect was calculated using a linear regression model for each body site was used for primary analysis. In the model, the response was the post-treatment log10 bacterial counts and predictors were the treatment effect as a fixed effect and the pre-treatment log10 bacterial counts as a covariate.95% CI: [0.88, 2.08]
Comparison: Tested on the abdomen Analysis was performed based on deferral letters from the FDA. Average treatment effect was calculated using a linear regression model for each body site was used for primary analysis. In the model, the response was the post-treatment log10 bacterial counts and predictors were the treatment effect as a fixed effect and the pre-treatment log10 bacterial counts as a covariate.95% CI: [0.72, 1.96]
Comparison: Groin95% CI: [1.38, 2.47]
Comparison: Groin95% CI: [0.73, 1.79]