Preoperative Skin Preparation
Conditions
Brief summary
The purpose of this study is to evaluate the safety and effectiveness of a topical antiseptic for preoperative skin preparation
Interventions
DRUGChlorhexidine gluconate
DRUGN,N'-(1,10-decanediyldi-1(4H)-Pyridinyl-4-ylidene)-Bis-(1-octanamine) Dihydrochloride
DRUGPlacebo
Sponsors
C. R. Bard
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Subjects may be of either sex, at least 18 years of age and of any race. * Subjects must be in good general health. * Subjects must read and sign an Informed Consent Form, Authorization to Use and Disclose Protected Health Information Form, and List of Restricted Products prior to participating in the study. * Female subjects must have a negative urine pregnancy test documented before treatment with test materials. * Screening day microbial baseline meeting minimum skin flora baseline requirements on abdomen and groin.
Exclusion criteria
* Known allergies or sensitivities to sunscreens, deodorants, laundry detergents, fragrances, vinyl, latex (rubber), alcohols, metals, inks, or to common antibacterial agents found in soaps, lotions, or ointments. * Exposure of test sites to strong detergents, solvents, or other irritants within the 14-day product-restriction period or during the test period. * Exposure of test sites to antimicrobial agents, medicated soaps, medicated shampoos, or medicated lotions, use of biocide-treated pools or hot tubs, use of tanning beds, or sunbathing during the 14-day product-restriction period or during the test period. * Wear fabric softener-treated clothing (including bug-repellent and UV-treated clothing) during the 14-day product-restriction period or during the test period. * Use of systemic or topical antibiotic medications, steroid medications (other than for hormonal contraception or post-menopausal reasons), or any other product known to affect the normal microbial flora of the skin during the 14-day product-restriction period or during the test period. * A medical diagnosis of a physical condition, such as a current or recent severe illness, mitral valve prolapse with a heart murmur, congenital heart disease, hepatitis B, hepatitis C, an organ transplant, or an immunocompromised condition such as AIDS (or HIV positive), lupus, diabetes, Crohn's disease, asthma or medicated multiple sclerosis. * Any tattoos, or scars 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, eczema) anywhere on the body that, in the opinion of the Principal Investigator, would compromise subject safety or study integrity. * 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 Screening Day baseline or Treatment Day baseline sample collection. * Participation in another clinical study in the past 30 days or current participation in another clinical study. * Showering, bathing, or swimming within the 72 hour period prior to sampling for baseline screening, the test day, or throughout the test period. * Pregnancy, plans to become pregnant or impregnate a sexual partner within the pre-test and test periods of the study, or nursing a child. All female subjects will be required to complete a urine pregnancy test on the day of test material application, prior to treatment. Both gender of subjects must be willing to use an acceptable method of contraception to prevent pregnancy for at least 14 days immediately preceding Treatment Day and throughout the duration of the study. * Any medical condition or use of any medications that, in the opinion of the Principal Investigator or Consulting Physician, would preclude participation. * Unwillingness to fulfill the performance requirements of the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Abdominal Site Responder Rates at 10 Minutes | 10 min | Individual anatomical sites were considered responders based on the standards set forth in the Food and Drug Administration Tentative Final Monograph for Effectiveness Testing of a Patient Preoperative Skin Preparation (FR 59:116, 17 June 94, pp. 31450-31452). Individually treated abdomen sites with a 2 log10/cm\^2 CFU reduction were considered responders, and individually treated groin sites with a 3 log10/cm\^2 CFU reduction were considered responders. |
| Percentage of Abdominal Site Responder Rates at 6 Hours | 6 hours | Individual anatomical sites were considered responders based on the standards set forth in the Food and Drug Administration Tentative Final Monograph for Effectiveness Testing of a Patient Preoperative Skin Preparation (FR 59:116, 17 June 94, pp. 31450-31452). Individually treated abdomen sites with a log10/cm\^2 CFU reduction greater than or equal to 0 were considered responders. |
| Percentage of Groin Site Responder Rate at 6 Hours | 6 hours | Individual anatomical sites were considered responders based on the standards set forth in the Food and Drug Administration Tentative Final Monograph for Effectiveness Testing of a Patient Preoperative Skin Preparation (FR 59:116, 17 June 94, pp. 31450-31452). Individually treated groin sites with a log10/cm\^2 CFU reduction greater than or equal to 0 were considered responders. |
| Percentage of Groin Sites Responder Rates at 10 Minutes | 10 minutes | Participants were considered responders based on the standards set forth in the Food and Drug Administration Tentative Final Monograph for Effectiveness Testing of a Patient Preoperative Skin Preparation (FR 59:116, 17 June 94, pp. 31450-31452). Individually treated groin sites with a 3 log10/cm\^2 CFU reduction were considered responders. |
Countries
United States
Participant flow
Pre-assignment details
Participants were only treated if they met baseline bacterial count criteria.
Participants by arm
| Arm | Count |
|---|---|
| Treated Participants Participants were treated with 2 of 3 study products, Investigational Product (IP, 0.4% OCT cloth), Vehicle Control (VC, vehicle formulation cloth), and/or Active Control (AC, SAGE 2% CHG cloth), 1 on the left side of the body (abdomen and inguen received the same product) and 1 on the right (abdomen and inguen received the same product). Therefore, treatment groups are not discrete categories and cannot be described by treatment group. | 145 |
| Total | 145 |
Baseline characteristics
| Characteristic | Treated Participants |
|---|---|
| Age, Continuous | 43 years STANDARD_DEVIATION 17 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 132 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 9 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 8 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 4 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 | 9 Participants |
| Race (NIH/OMB) White | 124 Participants |
| Sex: Female, Male Female | 31 Participants |
| Sex: Female, Male Male | 114 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 145 |
| other Total, other adverse events | 0 / 145 |
| serious Total, serious adverse events | 0 / 145 |
Outcome results
Primary
Percentage of Abdominal Site Responder Rates at 10 Minutes
Individual anatomical sites were considered responders based on the standards set forth in the Food and Drug Administration Tentative Final Monograph for Effectiveness Testing of a Patient Preoperative Skin Preparation (FR 59:116, 17 June 94, pp. 31450-31452). Individually treated abdomen sites with a 2 log10/cm\^2 CFU reduction were considered responders, and individually treated groin sites with a 3 log10/cm\^2 CFU reduction were considered responders.
Time frame: 10 min
Population: Number of individual sites that met treatment day bacterial requirements on the abdomen for analysis are IP = 48, AC = 48, VC = 19
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Investigational Product | Percentage of Abdominal Site Responder Rates at 10 Minutes | 79.2 percentage of abdomen sites |
| Active Control | Percentage of Abdominal Site Responder Rates at 10 Minutes | 85.4 percentage of abdomen sites |
| Vehicle Control | Percentage of Abdominal Site Responder Rates at 10 Minutes | 52.6 percentage of abdomen sites |
Primary
Percentage of Abdominal Site Responder Rates at 6 Hours
Individual anatomical sites were considered responders based on the standards set forth in the Food and Drug Administration Tentative Final Monograph for Effectiveness Testing of a Patient Preoperative Skin Preparation (FR 59:116, 17 June 94, pp. 31450-31452). Individually treated abdomen sites with a log10/cm\^2 CFU reduction greater than or equal to 0 were considered responders.
Time frame: 6 hours
Population: Number of abdomen sites passing treatment day bacterial requirements were analyzed for responder rates. The number of anatomical sites meeting treatment day bacterial requirements were IP = 48, AC = 48, VC = 19 for the abdomen.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Investigational Product | Percentage of Abdominal Site Responder Rates at 6 Hours | 89.6 percentage of abdomen sites |
| Active Control | Percentage of Abdominal Site Responder Rates at 6 Hours | 100.0 percentage of abdomen sites |
| Vehicle Control | Percentage of Abdominal Site Responder Rates at 6 Hours | 94.7 percentage of abdomen sites |
Primary
Percentage of Groin Site Responder Rate at 6 Hours
Individual anatomical sites were considered responders based on the standards set forth in the Food and Drug Administration Tentative Final Monograph for Effectiveness Testing of a Patient Preoperative Skin Preparation (FR 59:116, 17 June 94, pp. 31450-31452). Individually treated groin sites with a log10/cm\^2 CFU reduction greater than or equal to 0 were considered responders.
Time frame: 6 hours
Population: Individual sites that met treatment day bacterial requirements were analyzed for responder rates. Number of sites passing treatment day bacterial requirements on the groin were IP = 51, AC = 51, and VC = 18.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Investigational Product | Percentage of Groin Site Responder Rate at 6 Hours | 100 percentage of groin sites |
| Active Control | Percentage of Groin Site Responder Rate at 6 Hours | 98 percentage of groin sites |
| Vehicle Control | Percentage of Groin Site Responder Rate at 6 Hours | 100 percentage of groin sites |
Primary
Percentage of Groin Sites Responder Rates at 10 Minutes
Participants were considered responders based on the standards set forth in the Food and Drug Administration Tentative Final Monograph for Effectiveness Testing of a Patient Preoperative Skin Preparation (FR 59:116, 17 June 94, pp. 31450-31452). Individually treated groin sites with a 3 log10/cm\^2 CFU reduction were considered responders.
Time frame: 10 minutes
Population: Number of individually treated groin sites that passed treatment day bacterial requirements were IP = 51, AC = 51, and VC = 18.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Investigational Product | Percentage of Groin Sites Responder Rates at 10 Minutes | 72.5 percentage of groin sites |
| Active Control | Percentage of Groin Sites Responder Rates at 10 Minutes | 74.5 percentage of groin sites |
| Vehicle Control | Percentage of Groin Sites Responder Rates at 10 Minutes | 55.6 percentage of groin sites |