Trial Outcomes & Findings for Preoperative Skin Preparation Study to Evaluate the Antimicrobial Capabilities of Four Test Substances (NCT NCT04218110)
NCT ID: NCT04218110
Last Updated: 2021-10-22
Results Overview
Bacterial microflora (log10) will be measured via cup scrub method following the administration of the intervention
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
329 participants
Primary outcome timeframe
10 minutes
Results posted on
2021-10-22
Participant Flow
328 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
| Measure |
Project X 26ml
3.15% w/v CHG (chlorhexidine gluconate)/70% v/v IPA (isopropyl alcohol) contained within a saturated at use applicator. 26ml volume. Single use.
Isopropyl alcohol \& Chlorhexidine Gluconate Antiseptic: Application of antiseptic drug to the inguinal area of the subjects
|
Project X 10.5ml
3.15% w/v CHG (chlorhexidine gluconate)/70% v/v IPA (isopropyl alcohol) contained within a saturated at use applicator. 10.5ml volume. Single use.
Isopropyl alcohol \& Chlorhexidine Gluconate Antiseptic: Application of antiseptic drug to the inguinal area of the subjects
|
Project X 5.1ml
3.15% w/v CHG (chlorhexidine gluconate)/70% v/v IPA (isopropyl alcohol) contained within a saturated at use applicator. 10.5ml volume. Single use.
Isopropyl alcohol \& Chlorhexidine Gluconate Antiseptic: Application of antiseptic drug to the inguinal area of the subjects
|
Prevantics Maxi Swabstick
3.15% w/v CHG (chlorhexidine gluconate)/70% v/v IPA (isopropyl alcohol) contained within pre-saturated applicator. 5.1ml volume. Single use.
Prevantics 3.15 % / 70 % Swabstick: Application of antiseptic drug to the inguinal area of the subjects
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
82
|
81
|
83
|
83
|
|
Overall Study
Received Treatment
|
82
|
81
|
83
|
82
|
|
Overall Study
COMPLETED
|
82
|
81
|
83
|
82
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
1
|
Reasons for withdrawal
| Measure |
Project X 26ml
3.15% w/v CHG (chlorhexidine gluconate)/70% v/v IPA (isopropyl alcohol) contained within a saturated at use applicator. 26ml volume. Single use.
Isopropyl alcohol \& Chlorhexidine Gluconate Antiseptic: Application of antiseptic drug to the inguinal area of the subjects
|
Project X 10.5ml
3.15% w/v CHG (chlorhexidine gluconate)/70% v/v IPA (isopropyl alcohol) contained within a saturated at use applicator. 10.5ml volume. Single use.
Isopropyl alcohol \& Chlorhexidine Gluconate Antiseptic: Application of antiseptic drug to the inguinal area of the subjects
|
Project X 5.1ml
3.15% w/v CHG (chlorhexidine gluconate)/70% v/v IPA (isopropyl alcohol) contained within a saturated at use applicator. 10.5ml volume. Single use.
Isopropyl alcohol \& Chlorhexidine Gluconate Antiseptic: Application of antiseptic drug to the inguinal area of the subjects
|
Prevantics Maxi Swabstick
3.15% w/v CHG (chlorhexidine gluconate)/70% v/v IPA (isopropyl alcohol) contained within pre-saturated applicator. 5.1ml volume. Single use.
Prevantics 3.15 % / 70 % Swabstick: Application of antiseptic drug to the inguinal area of the subjects
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Preoperative Skin Preparation Study to Evaluate the Antimicrobial Capabilities of Four Test Substances
Baseline characteristics by cohort
| Measure |
Project X 26ml
n=82 Participants
3.15% w/v CHG/70% v/v IPA contained within a saturated at use applicator. 26ml volume. Single use.
Isopropyl alcohol \& Chlorhexidine Gluconate Antiseptic: Application of antiseptic drug to the inguinal area of the subjects
|
Project X 10.5ml
n=81 Participants
3.15% w/v CHG/70% v/v IPA contained within a saturated at use applicator. 10.5ml volume. Single use.
Isopropyl alcohol \& Chlorhexidine Gluconate Antiseptic: Application of antiseptic drug to the inguinal area of the subjects
|
Project X 5.1ml
n=83 Participants
3.15% w/v CHG/70% v/v IPA contained within a saturated at use applicator. 10.5ml volume. Single use.
Isopropyl alcohol \& Chlorhexidine Gluconate Antiseptic: Application of antiseptic drug to the inguinal area of the subjects
|
Prevantics Maxi Swabstick
n=83 Participants
3.15% w/v CHG/70% v/v IPA contained within pre-saturated applicator. 5.1ml volume. Single use.
Prevantics 3.15 % / 70 % Swabstick: Application of antiseptic drug to the inguinal area of the subjects
|
Total
n=329 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
54.76 years
STANDARD_DEVIATION 9.54 • n=5 Participants
|
54.39 years
STANDARD_DEVIATION 11.70 • n=7 Participants
|
54.48 years
STANDARD_DEVIATION 10.99 • n=5 Participants
|
55.06 years
STANDARD_DEVIATION 10.23 • n=4 Participants
|
54.67 years
STANDARD_DEVIATION 10.63 • n=21 Participants
|
|
Sex: Female, Male
Female
|
77 Participants
n=5 Participants
|
74 Participants
n=7 Participants
|
71 Participants
n=5 Participants
|
72 Participants
n=4 Participants
|
294 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
35 Participants
n=21 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
|
0 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
82 Participants
n=5 Participants
|
81 Participants
n=7 Participants
|
83 Participants
n=5 Participants
|
83 Participants
n=4 Participants
|
329 Participants
n=21 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
|
0 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
White/Caucasian
|
81 Participants
n=5 Participants
|
81 Participants
n=7 Participants
|
83 Participants
n=5 Participants
|
82 Participants
n=4 Participants
|
327 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
American Indian/Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Black/African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Subject Refused to Disclose
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Other/Combination of 2 or more races (specify)
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Region of Enrollment
Romania
|
82 participants
n=5 Participants
|
81 participants
n=7 Participants
|
83 participants
n=5 Participants
|
83 participants
n=4 Participants
|
329 participants
n=21 Participants
|
|
Weight
|
74.49 kg
STANDARD_DEVIATION 13.98 • n=5 Participants
|
73.37 kg
STANDARD_DEVIATION 13.84 • n=7 Participants
|
75.04 kg
STANDARD_DEVIATION 16.11 • n=5 Participants
|
74.98 kg
STANDARD_DEVIATION 15.06 • n=4 Participants
|
74.47 kg
STANDARD_DEVIATION 14.77 • n=21 Participants
|
|
Height
|
163.03 cm
STANDARD_DEVIATION 6.56 • n=5 Participants
|
163.54 cm
STANDARD_DEVIATION 7.84 • n=7 Participants
|
164.65 cm
STANDARD_DEVIATION 8.13 • n=5 Participants
|
164.15 cm
STANDARD_DEVIATION 7.85 • n=4 Participants
|
163.84 cm
STANDARD_DEVIATION 7.63 • n=21 Participants
|
PRIMARY outcome
Timeframe: 10 minutesPopulation: The Overall Number of Participants Analyzed represents the modified intent to treat (mITT) dataset where the Participant Flow represents 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 following the administration of the intervention
Outcome measures
| Measure |
Project X 26ml
n=88 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.
Isopropyl alcohol \& Chlorhexidine Gluconate Antiseptic: Application of antiseptic drug to the inguinal area of the subjects
|
Project X 10.5ml
n=84 evaluable sites
3.15% w/v CHG (chlorhexidine gluconate)/70% v/v IPA (isopropyl alcohol) contained within a saturated at use applicator. 10.5ml volume. Single use.
Isopropyl alcohol \& Chlorhexidine Gluconate Antiseptic: Application of antiseptic drug to the inguinal area of the subjects
|
Project X 5.1ml
n=93 evaluable sites
3.15% w/v CHG (chlorhexidine gluconate)/70% v/v IPA (isopropyl alcohol) contained within a saturated at use applicator. 10.5ml volume. Single use.
Isopropyl alcohol \& Chlorhexidine Gluconate Antiseptic: Application of antiseptic drug to the inguinal area of the subjects
|
Prevantics Maxi Swabstick
n=89 evaluable sites
3.15% w/v CHG (chlorhexidine gluconate)/70% v/v IPA (isopropyl alcohol) contained within pre-saturated applicator. 5.1ml volume. Single use.
Prevantics 3.15 % / 70 % Swabstick: Application of antiseptic drug to the inguinal area of the subjects
|
|---|---|---|---|---|
|
Change in Bacterial Microflora in the Inguinal Area
|
-3.86 log10 CFU
Standard Deviation 1.58
|
-4.34 log10 CFU
Standard Deviation 1.48
|
-3.65 log10 CFU
Standard Deviation 1.36
|
-3.80 log10 CFU
Standard Deviation 1.42
|
SECONDARY outcome
Timeframe: 30 secondsPopulation: The Overall Number of Participants Analyzed represents the modified intent to treat (mITT) dataset where the Participant Flow represents 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 following the administration of the intervention
Outcome measures
| Measure |
Project X 26ml
n=88 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.
Isopropyl alcohol \& Chlorhexidine Gluconate Antiseptic: Application of antiseptic drug to the inguinal area of the subjects
|
Project X 10.5ml
n=84 evaluable sites
3.15% w/v CHG (chlorhexidine gluconate)/70% v/v IPA (isopropyl alcohol) contained within a saturated at use applicator. 10.5ml volume. Single use.
Isopropyl alcohol \& Chlorhexidine Gluconate Antiseptic: Application of antiseptic drug to the inguinal area of the subjects
|
Project X 5.1ml
n=93 evaluable sites
3.15% w/v CHG (chlorhexidine gluconate)/70% v/v IPA (isopropyl alcohol) contained within a saturated at use applicator. 10.5ml volume. Single use.
Isopropyl alcohol \& Chlorhexidine Gluconate Antiseptic: Application of antiseptic drug to the inguinal area of the subjects
|
Prevantics Maxi Swabstick
n=89 evaluable sites
3.15% w/v CHG (chlorhexidine gluconate)/70% v/v IPA (isopropyl alcohol) contained within pre-saturated applicator. 5.1ml volume. Single use.
Prevantics 3.15 % / 70 % Swabstick: Application of antiseptic drug to the inguinal area of the subjects
|
|---|---|---|---|---|
|
Change in Bacterial Microflora in the Inguinal Area
|
-3.86 log10 CFU
Standard Deviation 1.55
|
-3.76 log10 CFU
Standard Deviation 1.36
|
-3.70 log10 CFU
Standard Deviation 1.58
|
-3.76 log10 CFU
Standard Deviation 1.48
|
Adverse Events
Project X 26ml
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Project X 10.5ml
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
| Measure |
Project X 26ml
n=82 participants at risk
3.15% w/v CHG/70% v/v IPA contained within a saturated at use applicator. 26ml volume. Single use.
Isopropyl alcohol \& Chlorhexidine Gluconate Antiseptic: Application of antiseptic drug to the inguinal area of the subjects
|
Project X 10.5ml
n=81 participants at risk
3.15% w/v CHG/70% v/v IPA contained within a saturated at use applicator. 10.5ml volume. Single use.
Isopropyl alcohol \& Chlorhexidine Gluconate Antiseptic: Application of antiseptic drug to the inguinal area of the subjects
|
Project X 5.1ml
n=83 participants at risk
3.15% w/v CHG/70% v/v IPA contained within a saturated at use applicator. 10.5ml volume. Single use.
Isopropyl alcohol \& Chlorhexidine Gluconate Antiseptic: Application of antiseptic drug to the inguinal area of the subjects
|
Prevantics Maxi Swabstick
n=82 participants at risk
3.15% w/v CHG/70% v/v IPA contained within pre-saturated applicator. 5.1ml volume. Single use.
Prevantics 3.15 % / 70 % Swabstick: Application of antiseptic drug to the inguinal area of the subjects
|
|---|---|---|---|---|
|
Pregnancy, puerperium and perinatal conditions
Adverse Event
|
0.00%
0/82 • 1.5 months
|
0.00%
0/81 • 1.5 months
|
0.00%
0/83 • 1.5 months
|
0.00%
0/82 • 1.5 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place