Trial Outcomes & Findings for Evaluation of the Antimicrobial Effectiveness of an Antimicrobial Cloth (NCT NCT03229759)

NCT ID: NCT03229759

Last Updated: 2021-04-23

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 99 participants
• Primary outcome timeframe: 10 minutes after application of test product
• Results posted on: 2021-04-23

Participant Flow

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.

Participant milestones

Measure	All Participants All screened participants
Overall Study STARTED	99
Overall Study Participants Treated	69
Overall Study Treated With Investigational Product	45
Overall Study Treated With Vehicle Control	47
Overall Study Treated With Saline Control	46
Overall Study COMPLETED	69
Overall Study NOT COMPLETED	30

Reasons for withdrawal

Measure	All Participants All screened participants
Overall Study Screen Failure	30

Baseline Characteristics

Evaluation of the Antimicrobial Effectiveness of an Antimicrobial Cloth

Baseline characteristics by cohort

Measure	Participants Treated n=69 Participants 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.
Age, Continuous	41 years STANDARD_DEVIATION 17 • n=5 Participants
Sex: Female, Male Female	17 Participants n=5 Participants
Sex: Female, Male Male	52 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	63 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	4 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	64 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	4 Participants n=5 Participants
Region of Enrollment United States	69 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Investigational Product n=41 Participants Investigational Product (IP) - Thermally treated polyester cloths impregnated with 0.4% weight by volume octenidine dihydrochloride (OCT) aqueous solution	Saline Control n=41 Participants Saline Control (SC) - 0.9% saline applied with polyester cloths	Vehicle Control n=42 Participants Vehicle Control (VC) Thermally treated polyester cloths impregnated with vehicle formulation.
Bacterial Count at 10 Minutes Post Application Abdomen- Baseline	3.55 log10 CFU/cm^2 Standard Deviation 0.40	3.61 log10 CFU/cm^2 Standard Deviation 0.41	3.66 log10 CFU/cm^2 Standard Deviation 0.40
Bacterial Count at 10 Minutes Post Application Groin- Baseline	5.95 log10 CFU/cm^2 Standard Deviation 0.60	6.07 log10 CFU/cm^2 Standard Deviation 0.53	5.89 log10 CFU/cm^2 Standard Deviation 0.47
Bacterial Count at 10 Minutes Post Application Groin- 10 minutes	2.98 log10 CFU/cm^2 Standard Deviation 1.14	4.90 log10 CFU/cm^2 Standard Deviation 0.56	4.25 log10 CFU/cm^2 Standard Deviation 0.68
Bacterial Count at 10 Minutes Post Application Abdomen- 10 minutes	1.19 log10 CFU/cm^2 Standard Deviation 1.28	2.64 log10 CFU/cm^2 Standard Deviation 0.58	2.56 log10 CFU/cm^2 Standard Deviation 0.97

Adverse Events

Subject Treated

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: 224-358-5019

Email: erin.zook@bd.com

Results disclosure agreements

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