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Trial Outcomes & Findings for Evaluating Safety and Effectiveness of Octenidine Dihydrochloride (NCT NCT03140254)

NCT ID: NCT03140254

Last Updated: 2025-12-11

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

145 participants

Primary outcome timeframe

6 hours

Results posted on

2025-12-11

Participant Flow

Participants were only treated if they met baseline bacterial count criteria.

Participant milestones

Participant milestones
Measure
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.
Overall Study
STARTED
145
Overall Study
Treatment IP - Groin
51
Overall Study
Treatment IP - Abdomen
48
Overall Study
Treatment AC - Groin
51
Overall Study
Treatment AC - Abdomen
48
Overall Study
Treatment VC - Groin
18
Overall Study
Treatment VC - Abdomen
19
Overall Study
COMPLETED
144
Overall Study
NOT COMPLETED
1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluating Safety and Effectiveness of Octenidine Dihydrochloride

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Treated Participants
n=145 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.
Age, Continuous
43 years
STANDARD_DEVIATION 17 • n=237 Participants
Sex: Female, Male
Female
31 Participants
n=237 Participants
Sex: Female, Male
Male
114 Participants
n=237 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
4 Participants
n=237 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
132 Participants
n=237 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
9 Participants
n=237 Participants
Race (NIH/OMB)
American Indian or Alaska Native
8 Participants
n=237 Participants
Race (NIH/OMB)
Asian
0 Participants
n=237 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=237 Participants
Race (NIH/OMB)
Black or African American
4 Participants
n=237 Participants
Race (NIH/OMB)
White
124 Participants
n=237 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=237 Participants
Race (NIH/OMB)
Unknown or Not Reported
9 Participants
n=237 Participants

PRIMARY outcome

Timeframe: 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

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."

Outcome measures

Outcome measures
Measure
Investigational Product
n=48 Individual abdominal sites
Investigational Product (IP) BDIP-0001 N,N'-(1,10-decanediyldi-1(4H)-Pyridinyl-4-ylidene)-Bis-(1-octanamine) Dihydrochloride
Active Control
n=48 Individual abdominal sites
Active Control (AC) Sage 2% Chlorhexidine gluconate
Vehicle Control
n=19 Individual abdominal sites
Vehicle Control (VC)
Percentage of Abdominal Site Responder Rates at 10 Minutes
79.2 percentage of abdomen sites
Interval 65.7 to 88.3
85.4 percentage of abdomen sites
Interval 72.8 to 92.8
52.6 percentage of abdomen sites
Interval 31.7 to 72.7

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure
Investigational Product
n=48 Individual Abdomen sites
Investigational Product (IP) BDIP-0001 N,N'-(1,10-decanediyldi-1(4H)-Pyridinyl-4-ylidene)-Bis-(1-octanamine) Dihydrochloride
Active Control
n=48 Individual Abdomen sites
Active Control (AC) Sage 2% Chlorhexidine gluconate
Vehicle Control
n=19 Individual Abdomen sites
Vehicle Control (VC)
Percentage of Abdominal Site Responder Rates at 6 Hours
89.6 percentage of abdomen sites
Interval 77.8 to 95.5
100.0 percentage of abdomen sites
Interval 92.6 to 100.0
94.7 percentage of abdomen sites
Interval 75.4 to 99.1

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure
Investigational Product
n=51 Individual Groin Sites
Investigational Product (IP) BDIP-0001 N,N'-(1,10-decanediyldi-1(4H)-Pyridinyl-4-ylidene)-Bis-(1-octanamine) Dihydrochloride
Active Control
n=51 Individual Groin Sites
Active Control (AC) Sage 2% Chlorhexidine gluconate
Vehicle Control
n=18 Individual Groin Sites
Vehicle Control (VC)
Percentage of Groin Site Responder Rate at 6 Hours
100 percentage of groin sites
Interval 93.0 to 100.0
98 percentage of groin sites
Interval 89.7 to 99.7
100 percentage of groin sites
Interval 82.4 to 100.0

PRIMARY outcome

Timeframe: 10 minutes

Population: Number of individually treated groin sites that passed treatment day bacterial requirements were IP = 51, AC = 51, and VC = 18.

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."

Outcome measures

Outcome measures
Measure
Investigational Product
n=51 Individual Groin Sites
Investigational Product (IP) BDIP-0001 N,N'-(1,10-decanediyldi-1(4H)-Pyridinyl-4-ylidene)-Bis-(1-octanamine) Dihydrochloride
Active Control
n=51 Individual Groin Sites
Active Control (AC) Sage 2% Chlorhexidine gluconate
Vehicle Control
n=18 Individual Groin Sites
Vehicle Control (VC)
Percentage of Groin Sites Responder Rates at 10 Minutes
72.5 percentage of groin sites
Interval 59.1 to 82.9
74.5 percentage of groin sites
Interval 61.1 to 84.5
55.6 percentage of groin sites
Interval 33.7 to 75.4

Adverse Events

All Participants

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Erin Zook

Becton Dickinson

Phone: 201-847-5351

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place