Trial Outcomes & Findings for In-vivo Efficacy of Patient Preoperative Prep, ZuraPrep (ZP) (NCT NCT03782103)
NCT ID: NCT03782103
Last Updated: 2023-02-08
Results Overview
A 3-log10 CFU/cm\^2 bacterial reduction on the inguinal region is considered a success.
COMPLETED
PHASE3
156 participants
30 seconds post product application
2023-02-08
Participant Flow
Enrollment consists of subjects that advanced from screening to randomization and treatment. Each subject had 2 test products applied bilaterally; therefore, the numbers will not add up uniformly across arms due to the pre-determined cohort/block design. Result totals will be less than than the treated number as the per subject/area/intervention anatomical site must have an acceptable baseline count/flora.
Unit of analysis: Ab or groin
Participant milestones
| Measure |
All Study Participants
ZP (Isopropyl alcohol (IPA) 70%) or CP or ZP Vehicle, applied topically to abdominal (for 30 seconds) or groin (for 2 minutes).
|
|---|---|
|
Overall Study
STARTED
|
156 72
|
|
Overall Study
ZP
|
156 72
|
|
Overall Study
CP
|
156 72
|
|
Overall Study
Vehicle
|
156 72
|
|
Overall Study
COMPLETED
|
156 72
|
|
Overall Study
NOT COMPLETED
|
0 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
In-vivo Efficacy of Patient Preoperative Prep, ZuraPrep (ZP)
Baseline characteristics by cohort
| Measure |
Treatment Population
n=72 Abdomen or groin
Each subject could have received 2 out of 3 test products randomly assigned. Demographics were not stratified by test product due to study design. While 156 was the treated population, to be evaluable for efficacy, each subject anatomical sample site (4/per subject) would need to pass the minimum log10 CFU/cm2 baseline requirements.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
156 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
37.90 years
STANDARD_DEVIATION 14.93 • n=5 Participants
|
|
Sex: Female, Male
Female
|
60 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
96 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
150 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
39 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
59 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
17 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
41 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
156 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 30 seconds post product applicationPopulation: Treated subjects with a treatment day baseline criteria of 5.0-7.5 log10 CFU/cm\^2 recoveries for each sampling site (2 groin sampling sites per subject).
A 3-log10 CFU/cm\^2 bacterial reduction on the inguinal region is considered a success.
Outcome measures
| Measure |
Mean Log Reduction - ZP (70% IPA) - Groin
n=79 Abdomen or groin
Isopropyl alcohol (IPA) 70%
ZP: Apply topically.
|
Mean Log Reduction - ChloraPrep - Groin
n=77 Abdomen or groin
Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70%
ChloraPrep: Apply topically.
|
Mean Log Reduction - ZP Vehicle - Groin
n=83 Abdomen or groin
ZP without IPA
ZP Vehicle: Apply topically.
|
|---|---|---|---|
|
Bacterial Reduction - Groin
|
4.133 log 10 CFU/cm2
Standard Deviation 0.4
|
3.642 log 10 CFU/cm2
Standard Deviation 0.5
|
1.277 log 10 CFU/cm2
Standard Deviation 0.6
|
PRIMARY outcome
Timeframe: 30 seconds post product applicationPopulation: Treated subjects with a treatment day baseline criteria of 3.0 - 5.5 Log10 CFU/cm\^2 recoveries.
A 2-log10 CFU/cm\^2 bacterial reduction on the abdomen region is considered a success.
Outcome measures
| Measure |
Mean Log Reduction - ZP (70% IPA) - Groin
n=83 Abdomen or groin
Isopropyl alcohol (IPA) 70%
ZP: Apply topically.
|
Mean Log Reduction - ChloraPrep - Groin
n=81 Abdomen or groin
Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70%
ChloraPrep: Apply topically.
|
Mean Log Reduction - ZP Vehicle - Groin
n=78 Abdomen or groin
ZP without IPA
ZP Vehicle: Apply topically.
|
|---|---|---|---|
|
Bacterial Reduction - Abdomen
|
3.036 Log10 CFU/cm^2
Standard Deviation 0.4
|
3.087 Log10 CFU/cm^2
Standard Deviation 0.4
|
1.234 Log10 CFU/cm^2
Standard Deviation 0.5
|
SECONDARY outcome
Timeframe: 6 hours post product applcationPopulation: Subjects were treated and post treatment the 6 hour log10 CFU/cm2 values were evaluated for persistence. If the 6 hour value was below the baseline log10CFU/cm2 value, then the site had a persistent effect. This was calculated as a binary variable: 1 if the site had a persistent effect; 0 if not.
Bacterial counts should not exceed baseline on the abdomen or groin region
Outcome measures
| Measure |
Mean Log Reduction - ZP (70% IPA) - Groin
n=72 Abdomen or groin
Isopropyl alcohol (IPA) 70%
ZP: Apply topically.
|
Mean Log Reduction - ChloraPrep - Groin
Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70%
ChloraPrep: Apply topically.
|
Mean Log Reduction - ZP Vehicle - Groin
ZP without IPA
ZP Vehicle: Apply topically.
|
|---|---|---|---|
|
Bacterial Counts Not Exceeding Baseline in the Abdomen and Groin Region
|
72 Abd or groin with persistent effect
|
—
|
—
|
Adverse Events
Zurex Prep (70% IPA)
ChloraPrep
Zurex Prep Vehicle
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place