Evaluating Safety and Effectiveness of Octenidine Dihydrochloride

Sponsor
CareFusion (Industry)
Overall Status
Completed
CT.gov ID
NCT03140254
Collaborator
(none)
145
Enrollment
1
Location
3
Arms
6.5
Actual Duration (Months)
22.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the safety and effectiveness of a topical antiseptic for preoperative skin preparation

Condition or DiseaseIntervention/TreatmentPhase
  • Drug: Chlorhexidine gluconate
  • Drug: N,N'-(1,10-decanediyldi-1(4H)-Pyridinyl-4-ylidene)-Bis-(1-octanamine) Dihydrochloride
  • Drug: Placebo
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
145 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Prevention
Official Title:
A RANDOMIZED, SINGLE-CENTER, BLINDED, PILOT CLINICAL EVALUATION OF THE ANTIMICROBIAL EFFECTIVENESS OF THERMALLY TREATED CLOTHS IMPREGNATED WITH 0.4% OCTENIDINE DIHYDROCHLORIDE AQUEOUS SOLUTION COMPARED TO THERMALLY TREATED CLOTHS IMPREGNATED WITH VEHICLE FORMULATION AND TO SAGE 2% CHLORHEXIDINE GLUCONATE CLOTH FOR PREOPERATIVE SKIN PREPARATION
Actual Study Start Date :
Sep 1, 2016
Actual Primary Completion Date :
Mar 17, 2017
Actual Study Completion Date :
Mar 17, 2017

Arms and Interventions

ArmIntervention/Treatment
Active Comparator: comparator

Chlorhexidine gluconate

Drug: Chlorhexidine gluconate

Experimental: experimental

BDIP-0001

Drug: N,N'-(1,10-decanediyldi-1(4H)-Pyridinyl-4-ylidene)-Bis-(1-octanamine) Dihydrochloride

Placebo Comparator: placebo

Vehicle

Drug: Placebo

Outcome Measures

Primary Outcome Measures

  1. 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."

  2. 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.

  3. 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.

  4. 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."

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts 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.

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1BioScience LaboratoriesButteMontanaUnited States59701

Sponsors and Collaborators

  • CareFusion

Investigators

  • Study Director: Kevin Burroughs, Becton, Dickinson and Company

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
CareFusion
ClinicalTrials.gov Identifier:
NCT03140254
Other Study ID Numbers:
  • MPS-16IPVAW01
First Posted:
May 4, 2017
Last Update Posted:
Aug 3, 2021
Last Verified:
Jul 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

Participant Flow

Recruitment Details
Pre-assignment DetailParticipants were only treated if they met baseline bacterial count criteria.
Arm/Group TitleTreated Participants
Arm/Group DescriptionParticipants 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.
Period Title: Overall Study
STARTED145
Treatment IP - Groin51
Treatment IP - Abdomen48
Treatment AC - Groin51
Treatment AC - Abdomen48
Treatment VC - Groin18
Treatment VC - Abdomen19
COMPLETED144
NOT COMPLETED1

Baseline Characteristics

Arm/Group TitleTreated Participants
Arm/Group DescriptionParticipants 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.
Overall Participants145
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]
43
(17)
Sex: Female, Male (Count of Participants)
Female
31
21.4%
Male
114
78.6%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino
4
2.8%
Not Hispanic or Latino
132
91%
Unknown or Not Reported
9
6.2%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native
8
5.5%
Asian
0
0%
Native Hawaiian or Other Pacific Islander
0
0%
Black or African American
4
2.8%
White
124
85.5%
More than one race
0
0%
Unknown or Not Reported
9
6.2%

Outcome Measures

1. Primary Outcome
TitlePercentage of Abdominal Site Responder Rates at 10 Minutes
DescriptionIndividual 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 Frame10 min

Outcome Measure Data

Analysis Population Description
Number of individual sites that met treatment day bacterial requirements on the abdomen for analysis are IP = 48, AC = 48, VC = 19
Arm/Group TitleInvestigational ProductActive ControlVehicle Control
Arm/Group DescriptionInvestigational Product (IP) BDIP-0001 N,N'-(1,10-decanediyldi-1(4H)-Pyridinyl-4-ylidene)-Bis-(1-octanamine) DihydrochlorideActive Control (AC) Sage 2% Chlorhexidine gluconateVehicle Control (VC)
Measure Participants778134
Measure Individual abdominal sites484819
Mean (95% Confidence Interval) [percentage of abdomen sites]
79.2
85.4
52.6
2. Primary Outcome
TitlePercentage of Abdominal Site Responder Rates at 6 Hours
DescriptionIndividual 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 Frame6 hours

Outcome Measure Data

Analysis Population Description
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/Group TitleInvestigational ProductActive ControlVehicle Control
Arm/Group DescriptionInvestigational Product (IP) BDIP-0001 N,N'-(1,10-decanediyldi-1(4H)-Pyridinyl-4-ylidene)-Bis-(1-octanamine) DihydrochlorideActive Control (AC) Sage 2% Chlorhexidine gluconateVehicle Control (VC)
Measure Participants778134
Measure Individual Abdomen sites484819
Mean (95% Confidence Interval) [percentage of abdomen sites]
89.6
100.0
94.7
3. Primary Outcome
TitlePercentage of Groin Site Responder Rate at 6 Hours
DescriptionIndividual 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 Frame6 hours

Outcome Measure Data

Analysis Population Description
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/Group TitleInvestigational ProductActive ControlVehicle Control
Arm/Group DescriptionInvestigational Product (IP) BDIP-0001 N,N'-(1,10-decanediyldi-1(4H)-Pyridinyl-4-ylidene)-Bis-(1-octanamine) DihydrochlorideActive Control (AC) Sage 2% Chlorhexidine gluconateVehicle Control (VC)
Measure Participants727421
Measure Individual Groin Sites515118
Mean (95% Confidence Interval) [percentage of groin sites]
100
98
100
4. Primary Outcome
TitlePercentage of Groin Sites Responder Rates at 10 Minutes
DescriptionParticipants 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 Frame10 minutes

Outcome Measure Data

Analysis Population Description
Number of individually treated groin sites that passed treatment day bacterial requirements were IP = 51, AC = 51, and VC = 18.
Arm/Group TitleInvestigational ProductActive ControlVehicle Control
Arm/Group DescriptionInvestigational Product (IP) BDIP-0001 N,N'-(1,10-decanediyldi-1(4H)-Pyridinyl-4-ylidene)-Bis-(1-octanamine) DihydrochlorideActive Control (AC) Sage 2% Chlorhexidine gluconateVehicle Control (VC)
Measure Participants737421
Measure Individual Groin Sites515118
Mean (95% Confidence Interval) [percentage of groin sites]
72.5
74.5
55.6

Adverse Events

Time Frame6 hours
Adverse Event Reporting Description
Arm/Group TitleAll Participants
Arm/Group DescriptionParticipants 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.
All Cause Mortality
All Participants
Affected / at Risk (%)# Events
Total0/145 (0%)
Serious Adverse Events
All Participants
Affected / at Risk (%)# Events
Total0/145 (0%)
Other (Not Including Serious) Adverse Events
All Participants
Affected / at Risk (%)# Events
Total0/145 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

Name/TitleErin Zook
OrganizationBecton Dickinson
Phone201-847-5351
Emailerin.zook@bd.com
Responsible Party:
CareFusion
ClinicalTrials.gov Identifier:
NCT03140254
Other Study ID Numbers:
  • MPS-16IPVAW01
First Posted:
May 4, 2017
Last Update Posted:
Aug 3, 2021
Last Verified:
Jul 1, 2021