Trial Outcomes & Findings for In-vivo Efficacy of Patient Preoperative Prep (NCT NCT02831998)

NCT ID: NCT02831998

Last Updated: 2023-02-08

Results Overview

A 3-log10 CFU/cm\^2 bacterial reduction on the inguinal region is considered a success.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

440 participants

Primary outcome timeframe

10 minutes post product application

Results posted on

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

Participant milestones
Measure	All Participants ZP (Isopropyl alcohol (IPA) 70%) or CP or ZP Vehicle Applied topically to ab (for 30 seconds) or groin (for 2 minutes).
Overall Study STARTED	440 440
Overall Study ZP	400 400
Overall Study CP	400 400
Overall Study Vehicle	80 80
Overall Study COMPLETED	440 440
Overall Study NOT COMPLETED	0 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

In-vivo Efficacy of Patient Preoperative Prep

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treated Population n=440 Participants 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 440 was the treated population, to be evaluable for efficacy, each subject anatomical sample site (4/per subject) would need to pass the minimum log10 baseline requirements.
Age, Continuous	38.4 years n=5 Participants
Sex: Female, Male Female	190 Participants n=5 Participants
Sex: Female, Male Male	250 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	45 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	379 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	16 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	119 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	84 Participants n=5 Participants
Race (NIH/OMB) White	176 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	61 Participants n=5 Participants

PRIMARY outcome

Timeframe: 10 minutes post product application

Population: 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

Outcome measures
Measure	Mean Log Reduction - ZP (70% IPA) - Groin n=330 Participants Isopropyl alcohol (IPA) 70% ZP: Apply topically.	Mean Log Reduction - ChloraPrep - Groin n=326 Participants Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70% ChloraPrep: Apply topically.	Mean Log Reduction - ZP Vehicle - Groin n=68 Participants ZP without IPA ZP Vehicle: Apply topically.
Bacterial Reduction	4.83 log10 CFU/cm^2 Standard Deviation 0.1	4.78 log10 CFU/cm^2 Standard Deviation 0.1	2.23 log10 CFU/cm^2 Standard Deviation 0.2

PRIMARY outcome

Timeframe: 10 minutes post product application

Population: 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

Outcome measures
Measure	Mean Log Reduction - ZP (70% IPA) - Groin n=342 Participants Isopropyl alcohol (IPA) 70% ZP: Apply topically.	Mean Log Reduction - ChloraPrep - Groin n=340 Participants Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70% ChloraPrep: Apply topically.	Mean Log Reduction - ZP Vehicle - Groin n=69 Participants ZP without IPA ZP Vehicle: Apply topically.
Bacterial Reduction - Abdomen	3.35 Log10 CFU/cm^2 Standard Deviation 0.1	3.34 Log10 CFU/cm^2 Standard Deviation 0.1	1.47 Log10 CFU/cm^2 Standard Deviation 0.2

Adverse Events

ZP (70% IPA)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

ChloraPrep

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

ZP Vehicle

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

Andrew Morgan

Zurex Pharma, Inc.

Phone: 16082039090

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: OTHER