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Trial Outcomes & Findings for Comparative Study of Antimicrobial Effectiveness (NCT NCT03817580)

NCT ID: NCT03817580

Last Updated: 2021-10-22

Results Overview

Bacterial microflora (log10) will be measured via cup scrub method after administration of the intervention

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

170 participants

Primary outcome timeframe

30 seconds

Results posted on

2021-10-22

Participant Flow

170 individual subjects were consented, screened, treated and completed the study. Each subject is able to receive 2 test products (1 on each side of their body).

Participant milestones

Participant milestones
Measure
Project X 26ml
3.15 % w/v CHG / 70% v/v IPA contained within a saturated at use swabstick. 26ml volume. Single use. Project X 26ml: Application of antiseptic drug to the inguinal and abdomen areas of the subjects
Project X 5.1ml
3.15 % w/v CHG / 70% v/v IPA contained within a saturated at use swabstick. 5.1ml volume. Single use. Project X 5.1ml: Application of antiseptic drug to the inguinal and abdomen areas of the subjects
Prevantics Maxi Swabstick
3.15 % w/v CHG / 70% v/v IPA. Swabstick. 5.1ml volume. Single use. Prevantics Maxi Swabstick: Application of antiseptic drug to the inguinal and abdomen areas of the subjects
Overall Study
STARTED
57
56
57
Overall Study
COMPLETED
57
56
57
Overall Study
NOT COMPLETED
0
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Comparative Study of Antimicrobial Effectiveness

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Project X 26ml
n=57 Participants
3.15 % w/v CHG / 70% v/v IPA contained within a saturated at use swabstick. 26ml volume. Single use. Project X 26ml: Application of antiseptic drug to the inguinal and abdomen areas of the subjects
Project X 5.1ml
n=56 Participants
3.15 % w/v CHG / 70% v/v IPA contained within a saturated at use swabstick. 5.1ml volume. Single use. Project X 5.1ml: Application of antiseptic drug to the inguinal and abdomen areas of the subjects
Prevantics Maxi Swabstick
n=57 Participants
3.15 % w/v CHG / 70% v/v IPA. Swabstick. 5.1ml volume. Single use. Prevantics Maxi Swabstick: Application of antiseptic drug to the inguinal and abdomen areas of the subjects
Total
n=170 Participants
Total of all reporting groups
Age, Continuous
58.4 years
n=5 Participants
56.8 years
n=7 Participants
57.6 years
n=5 Participants
57.6 years
n=4 Participants
Sex/Gender, Customized
Female
46 participants
n=5 Participants
45 participants
n=7 Participants
46 participants
n=5 Participants
137 participants
n=4 Participants
Sex/Gender, Customized
Male
11 participants
n=5 Participants
11 participants
n=7 Participants
11 participants
n=5 Participants
33 participants
n=4 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
57 Participants
n=5 Participants
56 Participants
n=7 Participants
57 Participants
n=5 Participants
170 Participants
n=4 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants

PRIMARY outcome

Timeframe: 30 seconds

Population: The overall number of participants analyzed above represents the per protocol data set while the participant flow data represents the treated set. Additionally, each subject is able to receive 2 test products (1 on each side of their body).

Bacterial microflora (log10) will be measured via cup scrub method after administration of the intervention

Outcome measures

Outcome measures
Measure
Project X 26ml
n=67 evaluable sites
3.15 % w/v CHG (chlorhexidine gluconate) / 70% v/v IPA (isopropyl alcohol) contained within a saturated at use swabstick. 26ml volume. Single use. Project X 26ml: Application of antiseptic drug to the inguinal and abdomen areas of the subjects
Project X 5.1ml
n=62 evaluable sites
3.15 % w/v CHG (chlorhexidine gluconate) / 70% v/v IPA (isopropyl alcohol) contained within a saturated at use swabstick. 5.1ml volume. Single use. Project X 5.1ml: Application of antiseptic drug to the inguinal and abdomen areas of the subjects
Prevantics Maxi Swabstick
n=59 evaluable sites
3.15 % w/v CHG (chlorhexidine gluconate) / 70% v/v IPA (isopropyl alcohol). Swabstick. 5.1ml volume. Single use. Prevantics Maxi Swabstick: Application of antiseptic drug to the inguinal and abdomen areas of the subjects
Change in Bacterial Microflora on the Inguinal Area
-3.92 log10 CFU
Standard Deviation 1.42
-3.69 log10 CFU
Standard Deviation 1.56
-3.94 log10 CFU
Standard Deviation 1.60

PRIMARY outcome

Timeframe: 10 minutes

Population: The overall number of participants analyzed above represents the per protocol data set while the participant flow data represents the treated set. Additionally, each subject is able to receive 2 test products (1 on each side of their body).

Bacterial microflora (log10) will be measured via cup scrub method after administration of the intervention

Outcome measures

Outcome measures
Measure
Project X 26ml
n=67 evaluable sites
3.15 % w/v CHG (chlorhexidine gluconate) / 70% v/v IPA (isopropyl alcohol) contained within a saturated at use swabstick. 26ml volume. Single use. Project X 26ml: Application of antiseptic drug to the inguinal and abdomen areas of the subjects
Project X 5.1ml
n=62 evaluable sites
3.15 % w/v CHG (chlorhexidine gluconate) / 70% v/v IPA (isopropyl alcohol) contained within a saturated at use swabstick. 5.1ml volume. Single use. Project X 5.1ml: Application of antiseptic drug to the inguinal and abdomen areas of the subjects
Prevantics Maxi Swabstick
n=59 evaluable sites
3.15 % w/v CHG (chlorhexidine gluconate) / 70% v/v IPA (isopropyl alcohol). Swabstick. 5.1ml volume. Single use. Prevantics Maxi Swabstick: Application of antiseptic drug to the inguinal and abdomen areas of the subjects
Change in Bacterial Microflora on the Inguinal Area
-4.07 log10 CFU
Standard Deviation 1.62
-4.04 log10 CFU
Standard Deviation 1.61
-4.17 log10 CFU
Standard Deviation 1.57

PRIMARY outcome

Timeframe: 6 hours

Population: The overall number of participants analyzed above represents the per protocol data set while the participant flow data represents the treated set. Additionally, each subject is able to receive 2 test products (1 on each side of their body).

Bacterial microflora (log10) will be measured via cup scrub method after administration of the intervention

Outcome measures

Outcome measures
Measure
Project X 26ml
n=67 evaluable sites
3.15 % w/v CHG (chlorhexidine gluconate) / 70% v/v IPA (isopropyl alcohol) contained within a saturated at use swabstick. 26ml volume. Single use. Project X 26ml: Application of antiseptic drug to the inguinal and abdomen areas of the subjects
Project X 5.1ml
n=62 evaluable sites
3.15 % w/v CHG (chlorhexidine gluconate) / 70% v/v IPA (isopropyl alcohol) contained within a saturated at use swabstick. 5.1ml volume. Single use. Project X 5.1ml: Application of antiseptic drug to the inguinal and abdomen areas of the subjects
Prevantics Maxi Swabstick
n=59 evaluable sites
3.15 % w/v CHG (chlorhexidine gluconate) / 70% v/v IPA (isopropyl alcohol). Swabstick. 5.1ml volume. Single use. Prevantics Maxi Swabstick: Application of antiseptic drug to the inguinal and abdomen areas of the subjects
Change in Bacterial Microflora on the Inguinal Area
-4.30 log10 CFU
Standard Deviation 1.43
-4.57 log10 CFU
Standard Deviation 1.62
-4.28 log10 CFU
Standard Deviation 1.53

PRIMARY outcome

Timeframe: 30 seconds

Population: The overall number of participants analyzed above represents the per protocol data set while the participant flow data represents the treated set. Additionally, each subject is able to receive 2 test products (1 on each side of their body).

Bacterial microflora (log10) will be measured via cup scrub method after administration of the intervention

Outcome measures

Outcome measures
Measure
Project X 26ml
n=59 evaluable sites
3.15 % w/v CHG (chlorhexidine gluconate) / 70% v/v IPA (isopropyl alcohol) contained within a saturated at use swabstick. 26ml volume. Single use. Project X 26ml: Application of antiseptic drug to the inguinal and abdomen areas of the subjects
Project X 5.1ml
n=59 evaluable sites
3.15 % w/v CHG (chlorhexidine gluconate) / 70% v/v IPA (isopropyl alcohol) contained within a saturated at use swabstick. 5.1ml volume. Single use. Project X 5.1ml: Application of antiseptic drug to the inguinal and abdomen areas of the subjects
Prevantics Maxi Swabstick
n=63 evaluable sites
3.15 % w/v CHG (chlorhexidine gluconate) / 70% v/v IPA (isopropyl alcohol). Swabstick. 5.1ml volume. Single use. Prevantics Maxi Swabstick: Application of antiseptic drug to the inguinal and abdomen areas of the subjects
Change in Bacterial Microflora on the Abdomen
-3.09 log10 CFU
Standard Deviation 0.76
-2.95 log10 CFU
Standard Deviation 1.11
-2.85 log10 CFU
Standard Deviation 1.08

PRIMARY outcome

Timeframe: 10 minutes

Population: The overall number of participants analyzed above represents the per protocol data set while the participant flow data represents the treated set. Additionally, each subject is able to receive 2 test products (1 on each side of their body).

Bacterial microflora (log10) will be measured via cup scrub method after administration of the intervention

Outcome measures

Outcome measures
Measure
Project X 26ml
n=59 evaluable sites
3.15 % w/v CHG (chlorhexidine gluconate) / 70% v/v IPA (isopropyl alcohol) contained within a saturated at use swabstick. 26ml volume. Single use. Project X 26ml: Application of antiseptic drug to the inguinal and abdomen areas of the subjects
Project X 5.1ml
n=59 evaluable sites
3.15 % w/v CHG (chlorhexidine gluconate) / 70% v/v IPA (isopropyl alcohol) contained within a saturated at use swabstick. 5.1ml volume. Single use. Project X 5.1ml: Application of antiseptic drug to the inguinal and abdomen areas of the subjects
Prevantics Maxi Swabstick
n=63 evaluable sites
3.15 % w/v CHG (chlorhexidine gluconate) / 70% v/v IPA (isopropyl alcohol). Swabstick. 5.1ml volume. Single use. Prevantics Maxi Swabstick: Application of antiseptic drug to the inguinal and abdomen areas of the subjects
Change in Bacterial Microflora on the Abdomen
-3.15 log10 CFU
Standard Deviation 0.85
-2.97 log10 CFU
Standard Deviation 1.06
-3.01 log10 CFU
Standard Deviation 0.82

PRIMARY outcome

Timeframe: 6 hours

Population: The overall number of participants analyzed above represents the per protocol data set while the participant flow data represents the treated set. Additionally, each subject is able to receive 2 test products (1 on each side of their body).

Bacterial microflora (log10) will be measured via cup scrub method after administration of the intervention

Outcome measures

Outcome measures
Measure
Project X 26ml
n=59 evaluable sites
3.15 % w/v CHG (chlorhexidine gluconate) / 70% v/v IPA (isopropyl alcohol) contained within a saturated at use swabstick. 26ml volume. Single use. Project X 26ml: Application of antiseptic drug to the inguinal and abdomen areas of the subjects
Project X 5.1ml
n=59 evaluable sites
3.15 % w/v CHG (chlorhexidine gluconate) / 70% v/v IPA (isopropyl alcohol) contained within a saturated at use swabstick. 5.1ml volume. Single use. Project X 5.1ml: Application of antiseptic drug to the inguinal and abdomen areas of the subjects
Prevantics Maxi Swabstick
n=63 evaluable sites
3.15 % w/v CHG (chlorhexidine gluconate) / 70% v/v IPA (isopropyl alcohol). Swabstick. 5.1ml volume. Single use. Prevantics Maxi Swabstick: Application of antiseptic drug to the inguinal and abdomen areas of the subjects
Change in Bacterial Microflora on the Abdomen
-3.19 log10 CFU
Standard Deviation 0.87
-3.27 log10 CFU
Standard Deviation 0.95
-3.18 log10 CFU
Standard Deviation 0.91

Adverse Events

Project X 26ml

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

Project X 5.1ml

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

Prevantics Maxi Swabstick

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

Commercial Manager

Eurofins EVIC

Phone: 40 213357090

Results disclosure agreements

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