Trial Outcomes & Findings for Efficacy Study of Patient Preoperative Preps In-vivo (NCT NCT04756154)

Last Updated: 2024-10-01

Results Overview

Immediate efficacy endpoint which is defined as the average treatment effect (ATE) log10 CFU/cm2 of skin flora on the inguinal region at 10 minutes following application of the study products relative to the treatment day baseline skin flora

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

154 participants

Primary outcome timeframe

10 minutes

Results posted on

2024-10-01

Participant Flow

This is a randomized, paired-comparison design where each subject received two of the planned treatments, one on the left side and one on the right. Each subject provided two inguinal test sites, left and right. 154 subjects were randomized for the inguinal region resulting in 308 applications of test products.

Unit of analysis: Test sites on skin

Participant milestones

Participant milestones
Measure	CHG/IPA Surgical Skin Preparation Apply topically to the inguinal region for 2 minutes	CHG/IPA Film-Forming Surgical Skin Preparation Apply topically to the inguinal region for 2 minutes	Normal Saline Apply topically to the inguinal region for 2 minutes
Overall Study STARTED	135 135	135 135	38 38
Overall Study COMPLETED	104 104	106 106	31 31
Overall Study NOT COMPLETED	31 31	29 29	7 7

Reasons for withdrawal

Reasons for withdrawal
Measure	CHG/IPA Surgical Skin Preparation Apply topically to the inguinal region for 2 minutes	CHG/IPA Film-Forming Surgical Skin Preparation Apply topically to the inguinal region for 2 minutes	Normal Saline Apply topically to the inguinal region for 2 minutes
Overall Study Did not meet treatment day baseline	30	28	7
Overall Study Did not return for final sample collection	1	1	0

Baseline Characteristics

Efficacy Study of Patient Preoperative Preps In-vivo

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	CHG/IPA Surgical Skin Preparation n=135 Test sites on skin Apply topically to the inguinal region for 2 minutes	CHG/IPA Film-Forming Surgical Skin Preparation n=135 Test sites on skin Apply topically to the inguinal region for 2 minutes	Normal Saline n=38 Test sites on skin Apply topically to the inguinal region for 2 minutes	Total n=308 Test sites on skin Total of all reporting groups
Age, Customized Between 18-65 years	126 Test sites on skin n=25 Test sites on skin	126 Test sites on skin n=25 Test sites on skin	38 Test sites on skin n=23 Test sites on skin	290 Test sites on skin n=23 Test sites on skin
Age, Customized > 65 years	9 Test sites on skin n=25 Test sites on skin	9 Test sites on skin n=25 Test sites on skin	0 Test sites on skin n=23 Test sites on skin	18 Test sites on skin n=245 Test sites on skin
Sex/Gender, Customized Female	62 Test sites on skin n=25 Test sites on skin	62 Test sites on skin n=25 Test sites on skin	16 Test sites on skin n=23 Test sites on skin	140 Test sites on skin n=245 Test sites on skin
Sex/Gender, Customized Male	73 Test sites on skin n=25 Test sites on skin	73 Test sites on skin n=25 Test sites on skin	22 Test sites on skin n=23 Test sites on skin	168 Test sites on skin n=245 Test sites on skin
Race/Ethnicity, Customized American Indian or Alaska Native	2 Test sites on skin n=25 Test sites on skin	2 Test sites on skin n=25 Test sites on skin	0 Test sites on skin n=23 Test sites on skin	4 Test sites on skin n=23 Test sites on skin
Race/Ethnicity, Customized Asian	61 Test sites on skin n=25 Test sites on skin	64 Test sites on skin n=25 Test sites on skin	13 Test sites on skin n=23 Test sites on skin	138 Test sites on skin n=245 Test sites on skin
Race/Ethnicity, Customized Black or African American	18 Test sites on skin n=25 Test sites on skin	21 Test sites on skin n=25 Test sites on skin	5 Test sites on skin n=23 Test sites on skin	44 Test sites on skin n=245 Test sites on skin
Race/Ethnicity, Customized Native Hawaiian	1 Test sites on skin n=25 Test sites on skin	2 Test sites on skin n=25 Test sites on skin	1 Test sites on skin n=23 Test sites on skin	4 Test sites on skin n=23 Test sites on skin
Race/Ethnicity, Customized White	49 Test sites on skin n=25 Test sites on skin	43 Test sites on skin n=25 Test sites on skin	18 Test sites on skin n=23 Test sites on skin	110 Test sites on skin n=23 Test sites on skin
Race/Ethnicity, Customized Other	4 Test sites on skin n=25 Test sites on skin	3 Test sites on skin n=25 Test sites on skin	1 Test sites on skin n=23 Test sites on skin	8 Test sites on skin n=245 Test sites on skin
Region of Enrollment United States	135 Test sites on skin n=25 Test sites on skin	135 Test sites on skin n=25 Test sites on skin	38 Test sites on skin n=23 Test sites on skin	308 Test sites on skin n=245 Test sites on skin

PRIMARY outcome

Timeframe: 10 minutes

Population: The primary analysis data set used a modified intent-to-treat population. Subjects were excluded who did not meet the treatment day baseline requirements of 5.00 log10/cm\^2 on the inguinal test site. The number treatment arm-specific test sites is equal to the number of participants.

Outcome measures

Outcome measures
Measure	CHG/IPA Surgical Skin Preparation n=106 Participants Apply topically to the inguinal region for 2 minutes	CHG/IPA Film-Forming Surgical Skin Preparation: n=104 Participants Apply topically to the inguinal region for 2 minutes	Normal Saline n=31 Participants Apply topically to the inguinal region for 2 minutes
Log Change (Reduction) in Skin Flora on the Inguinal Region at 10 Minutes	3.60 Log10 CFU/cm^2 Standard Deviation 0.816	3.61 Log10 CFU/cm^2 Standard Deviation 0.837	1.15 Log10 CFU/cm^2 Standard Deviation 0.411

PRIMARY outcome

Timeframe: 6 hours

Persistent efficacy endpoint which is a binary endpoint with success/failure, where "success" is defined as log10 CFU/cm2 of skin flora on the inguinal region at 6 hours following application of the study products being lower than the treatment day baseline skin flora

Outcome measures

Outcome measures
Measure	CHG/IPA Surgical Skin Preparation n=106 Participants Apply topically to the inguinal region for 2 minutes	CHG/IPA Film-Forming Surgical Skin Preparation: n=104 Participants Apply topically to the inguinal region for 2 minutes	Normal Saline n=31 Participants Apply topically to the inguinal region for 2 minutes
Log Change (Reduction) in Skin Flora on the Inguinal Region at 6 Hours	1.98 Log10 CFU/cm^2 Standard Deviation 0.806	2.40 Log10 CFU/cm^2 Standard Deviation 0.792	1.03 Log10 CFU/cm^2 Standard Deviation 0.443

Adverse Events

CHG/IPA Surgical Skin Preparation

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

CHG/IPA Film-Forming Surgical Skin Preparation

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Normal Saline

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

Linda Olson

Phone: 651-736-3586

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place