Trial Outcomes & Findings for Pilot Evaluation of Two Test Materials With a Positive Control When Used as a Patient Preoperative Skin Preparation (NCT NCT03861780)

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

152 participants

Primary outcome timeframe

30 seconds

Results posted on

2021-10-22

Participant Flow

152 subjects were consented, randomized into the study, treated with test product 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 applicator. 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 applicator. 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. Single use. Prevantics Maxi Swabstick: Application of antiseptic drug to the inguinal and abdomen areas of the subjects
Overall Study STARTED	51	50	51
Overall Study COMPLETED	51	50	51
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pilot Evaluation of Two Test Materials With a Positive Control When Used as a Patient Preoperative Skin Preparation

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Project X 26ml n=51 Participants 3.15% w/v CHG / 70% v/v IPA contained within a saturated at use applicator. 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=50 Participants 3.15% w/v CHG / 70% v/v IPA contained within a saturated at use applicator. 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=51 Participants 3.15% w/v CHG / 70% v/v IPA. Swabstick. Single use. Prevantics Maxi Swabstick: Application of antiseptic drug to the inguinal and abdomen areas of the subjects	Total n=152 Participants Total of all reporting groups
Age, Continuous	42.1 years n=5 Participants	43.4 years n=7 Participants	44.7 years n=5 Participants	43.4 years n=4 Participants
Sex: Female, Male Female	22 Participants n=5 Participants	28 Participants n=7 Participants	28 Participants n=5 Participants	78 Participants n=4 Participants
Sex: Female, Male Male	29 Participants n=5 Participants	22 Participants n=7 Participants	23 Participants n=5 Participants	74 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	38 Participants n=5 Participants	40 Participants n=7 Participants	40 Participants n=5 Participants	118 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	7 Participants n=5 Participants	5 Participants n=7 Participants	4 Participants n=5 Participants	16 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	6 Participants n=5 Participants	5 Participants n=7 Participants	7 Participants n=5 Participants	18 Participants n=4 Participants

PRIMARY outcome

Timeframe: 30 seconds

Population: The overall number of participants analyzed represents the modified intent to treat (mITT) data set. The Participant Flow was is based on the intent to treat (ITT) dataset. 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 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 applicator. 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=58 evaluable sites 3.15% w/v CHG (chlorhexidine gluconate) / 70% v/v IPA (isopropyl alcohol) contained within a saturated at use applicator. 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=53 evaluable sites 3.15% w/v CHG (chlorhexidine gluconate) / 70% v/v IPA (isopropyl alcohol). Swabstick. 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	-3.7 log10 CFU Standard Deviation 1.4	-3.1 log10 CFU Standard Deviation 1.3	-3.5 log10 CFU Standard Deviation 1.4

PRIMARY outcome

Timeframe: 10 minutes

Population: The overall number of participants analyzed represents the modified intent to treat (mITT) data set. The Participant Flow was is based on the intent to treat (ITT) dataset. 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 administration of the intervention

Outcome measures

Outcome measures
Measure	Project X 26ml n=58 evaluable sites 3.15% w/v CHG (chlorhexidine gluconate) / 70% v/v IPA (isopropyl alcohol) contained within a saturated at use applicator. 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=58 evaluable sites 3.15% w/v CHG (chlorhexidine gluconate) / 70% v/v IPA (isopropyl alcohol) contained within a saturated at use applicator. 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=53 evaluable sites 3.15% w/v CHG (chlorhexidine gluconate) / 70% v/v IPA (isopropyl alcohol). Swabstick. 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	-3.5 log10 CFU Standard Deviation 1.2	-3.2 log10 CFU Standard Deviation 1.5	-3.3 log10 CFU Standard Deviation 1.6

PRIMARY outcome

Timeframe: 6 hours

Population: The overall number of participants analyzed represents the modified intent to treat (mITT) data set. The Participant Flow was is based on the intent to treat (ITT) dataset. 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 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 applicator. 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=58 evaluable sites 3.15% w/v CHG (chlorhexidine gluconate) / 70% v/v IPA (isopropyl alcohol) contained within a saturated at use applicator. 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=53 evaluable sites 3.15% w/v CHG (chlorhexidine gluconate) / 70% v/v IPA (isopropyl alcohol). Swabstick. 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	-3.8 log10 CFU Standard Deviation 1.3	-3.6 log10 CFU Standard Deviation 1.5	-3.4 log10 CFU Standard Deviation 1.4

PRIMARY outcome

Timeframe: 30 seconds

Population: The overall number of participants analyzed represents the modified intent to treat (mITT) data set. The Participant Flow was is based on the intent to treat (ITT) dataset. 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 administration of the intervention

Outcome measures

Outcome measures
Measure	Project X 26ml n=50 evaluable sites 3.15% w/v CHG (chlorhexidine gluconate) / 70% v/v IPA (isopropyl alcohol) contained within a saturated at use applicator. 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=57 evaluable sites 3.15% w/v CHG (chlorhexidine gluconate) / 70% v/v IPA (isopropyl alcohol) contained within a saturated at use applicator. 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 evaluable sites 3.15% w/v CHG (chlorhexidine gluconate) / 70% v/v IPA (isopropyl alcohol). Swabstick. 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 Area	-3.2 log10 CFU Standard Deviation 1.1	-2.9 log10 CFU Standard Deviation 1.1	-2.8 log10 CFU Standard Deviation 1.1

PRIMARY outcome

Timeframe: 10 minutes

Population: The overall number of participants analyzed represents the modified intent to treat (mITT) data set. The Participant Flow was is based on the intent to treat (ITT) dataset. 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 administration of the intervention

Outcome measures

Outcome measures
Measure	Project X 26ml n=50 evaluable sites 3.15% w/v CHG (chlorhexidine gluconate) / 70% v/v IPA (isopropyl alcohol) contained within a saturated at use applicator. 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=57 evaluable sites 3.15% w/v CHG (chlorhexidine gluconate) / 70% v/v IPA (isopropyl alcohol) contained within a saturated at use applicator. 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 evaluable sites 3.15% w/v CHG (chlorhexidine gluconate) / 70% v/v IPA (isopropyl alcohol). Swabstick. 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 Area	-3.0 log10 CFU Standard Deviation 1.2	-2.9 log10 CFU Standard Deviation 1.1	-2.9 log10 CFU Standard Deviation 1.0

PRIMARY outcome

Timeframe: 6 hours

Population: The overall number of participants analyzed represents the modified intent to treat (mITT) data set. The Participant Flow was is based on the intent to treat (ITT) dataset. 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 administration of the intervention

Outcome measures

Outcome measures
Measure	Project X 26ml n=51 evaluable sites 3.15% w/v CHG (chlorhexidine gluconate) / 70% v/v IPA (isopropyl alcohol) contained within a saturated at use applicator. 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=58 evaluable sites 3.15% w/v CHG (chlorhexidine gluconate) / 70% v/v IPA (isopropyl alcohol) contained within a saturated at use applicator. 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 evaluable sites 3.15% w/v CHG (chlorhexidine gluconate) / 70% v/v IPA (isopropyl alcohol). Swabstick. 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 Area	-2.9 log10 CFU Standard Deviation 1.0	-3.0 log10 CFU Standard Deviation 1.0	-2.7 log10 CFU Standard Deviation 1.0

Adverse Events

Project X 26 mL

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Project X 5.1 mL

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

Other adverse events
Measure	Project X 26 mL n=51 participants at risk 3.15% w/v CHG (chlorhexidine gluconate) / 70% v/v IPA (isopropyl alcohol) contained within a saturated at use applicator. 26ml volume. Single use. Project X 26ml: Application of antiseptic drug to the inguinal and abdomen areas of the subjects	Project X 5.1 mL n=50 participants at risk 3.15% w/v CHG (chlorhexidine gluconate) / 70% v/v IPA (isopropyl alcohol) contained within a saturated at use applicator. 5.1 ml volume. Single use. Project X 5.1 ml: Application of antiseptic drug to the inguinal and abdomen areas of the subjects	Prevantics Maxi Swabstick n=51 participants at risk 3.15% w/v CHG (chlorhexidine gluconate) / 70% v/v IPA (isopropyl alcohol) Swabstick. Single use. Application of antiseptic drug to inguinal and abdomen areas of the subjects
Skin and subcutaneous tissue disorders Treatment Related AE	2.0% 1/51 • 2 months	0.00% 0/50 • 2 months	0.00% 0/51 • 2 months

Additional Information

Principal Investigator II/Training Coordinator

Bioscience Laboratories

Phone: (406) 587-5735

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place