Trial Outcomes & Findings for Clinical Evaluation of Patient Preoperative Prep (NCT NCT02831816)

NCT ID: NCT02831816

Last Updated: 2021-07-16

Results Overview

A a 3-log per cm2 bacterial reduction on the inguinal region is considered a success.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

640 participants

Primary outcome timeframe

10 minutes post product application

Results posted on

2021-07-16

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	640 640
Overall Study ZP	589 589
Overall Study CP	590 590
Overall Study Vehicle	131 131
Overall Study COMPLETED	640 640
Overall Study NOT COMPLETED	0 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Clinical Evaluation of Patient Preoperative Prep

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treated Population n=640 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 640 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/cm\^2 baseline requirements.
Age, Continuous	30 years n=5 Participants
Sex: Female, Male Female	164 Participants n=5 Participants
Sex: Female, Male Male	476 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	20 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	581 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	39 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	15 Participants n=5 Participants
Race (NIH/OMB) Asian	8 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	9 Participants n=5 Participants
Race (NIH/OMB) White	576 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	32 Participants n=5 Participants

PRIMARY outcome

Timeframe: 10 minutes post product application

Population: Treated subjects with treatment day baseline criteria 5.0-7.5 log recoveries.

A a 3-log per cm2 bacterial reduction on the inguinal region is considered a success.

Outcome measures

Outcome measures
Measure	Mean Log Reduction - ZP (70% IPA) - Groin n=342 Participants Isopropyl alcohol (IPA) 70% ZuraPrep: Apply topically to groin.	Mean Log Reduction - Groin - ChloraPrep n=352 Participants Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70% ChloraPrep: Apply topically to groin.	Mean Log Reduction - Groin - ZP Vehicle n=74 Participants ZP without IPA ZP Vehicle: Apply topically to the groin.
Bacterial Reduction	4.04 log10 cfu/cm^2 Standard Deviation 1.33	4.01 log10 cfu/cm^2 Standard Deviation 1.43	1.60 log10 cfu/cm^2 Standard Deviation 0.69

PRIMARY outcome

Timeframe: 10 minutes post product application

Population: Treated subjects with treatment day baseline criteria 3.0-5.5 log10 recoveries.

A 2-log per cm2 bacterial reduction on the abdomen region is considered a success.

Outcome measures

Outcome measures
Measure	Mean Log Reduction - ZP (70% IPA) - Groin n=324 Participants Isopropyl alcohol (IPA) 70% ZuraPrep: Apply topically to groin.	Mean Log Reduction - Groin - ChloraPrep n=320 Participants Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70% ChloraPrep: Apply topically to groin.	Mean Log Reduction - Groin - ZP Vehicle n=68 Participants ZP without IPA ZP Vehicle: Apply topically to the groin.
Bacterial Reduction - Abdomen	2.99 log10 cfu/cm^2 Standard Deviation 1.1	2.79 log10 cfu/cm^2 Standard Deviation 1.1	1.00 log10 cfu/cm^2 Standard Deviation 0.9

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