Trial Outcomes & Findings for Antimicrobial Efficacy of 2% CHG (Chlorhexidine Gluconate) (NCT NCT02530541)

Results Overview

Evaluate the Log Reduction of normal flora at various timepoints.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

33 participants

Primary outcome timeframe

10 min, 6 hr and 8 hr

Results posted on

2021-04-30

Participant Flow

Upon achieving sufficient microbial growth prior to product application on either the abdomen, groin or both abdomen and groin regions, sites of the participant were then randomized to receive one or two products for evaluation for up to 4 sites. Differences in the number of participants is based on microbial qualifications.

Participants were randomized to be treated with at least 2 treatments/ Arms (out of 3) at the same time for both groin and abdomen. Total numbers represent sites not the individual number of participants.

Unit of analysis: sites

Participant milestones

Participant milestones
Measure	CHG 1 Min Abdomen CHG 1 min Abdomen sites	CHG 2 Min Abdomen CHG 2 min Abdomen sites	Comparator CHG Abdomen Marketed CHG - only applied per products instructions for use	CHG 1 Min Groin CHG 1 min Groin sites	CHG 2 Min Groin CHG 2 min Groin sites	Comparator CHG Groin Marketed CHG - only applied per products instructions for use
Overall Study STARTED	21 21	23 23	22 22	21 21	20 20	19 19
Overall Study COMPLETED	14 14	15 15	14 14	15 15	15 15	14 14
Overall Study NOT COMPLETED	7 7	8 8	8 8	6 6	5 5	5 5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Antimicrobial Efficacy of 2% CHG (Chlorhexidine Gluconate)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	CHG 1, CHG 2, Comparator CHG n=33 Participants Participants could receive up to 2 different treatments at the same time. Treatments included CHG at 1 min, CHG at 2 min or Comparator CHG.
Age, Customized Age	48 years n=5 Participants
Sex: Female, Male Female	21 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants
Region of Enrollment United States	33 Sites exposed n=5 Participants

PRIMARY outcome

Timeframe: 10 min, 6 hr and 8 hr

Population: Determine 70% responder rates

Evaluate the Log Reduction of normal flora at various timepoints.

Outcome measures

Outcome measures
Measure	CHG 1 Min Abdomen n=21 Sites Exposed 1 min application time	CHG 2 Min Abdomen n=23 Sites Exposed 2 min application time	Comparator CHG Abdomen n=22 Sites Exposed Marketed CHG Standard Application Time	CHG 1 Min Groin n=21 Sites Exposed 1 min application time	CHG 2 Min Groin n=20 Sites Exposed 2 min application time	Comparator CHG Groin n=19 Sites Exposed Comparator CHG Standard Application Time
Log Reduction of Bacterial Flora on the Abdomen and Groin 10 min	1.9 Log10 Reductions Standard Deviation 1.6	2.0 Log10 Reductions Standard Deviation 1.5	1.3 Log10 Reductions Standard Deviation 1.8	1.9 Log10 Reductions Standard Deviation 0.6	2.4 Log10 Reductions Standard Deviation 1.1	2.1 Log10 Reductions Standard Deviation 1.1
Log Reduction of Bacterial Flora on the Abdomen and Groin 6 hour	2.6 Log10 Reductions Standard Deviation 1.3	2.5 Log10 Reductions Standard Deviation 1.4	1.7 Log10 Reductions Standard Deviation 1.6	2.3 Log10 Reductions Standard Deviation 0.8	2.8 Log10 Reductions Standard Deviation 1.2	1.9 Log10 Reductions Standard Deviation 0.8
Log Reduction of Bacterial Flora on the Abdomen and Groin 8 hour	2.6 Log10 Reductions Standard Deviation 1.0	2.2 Log10 Reductions Standard Deviation 1.6	1.4 Log10 Reductions Standard Deviation 1.2	2.5 Log10 Reductions Standard Deviation 0.9	2.7 Log10 Reductions Standard Deviation 0.8	2.2 Log10 Reductions Standard Deviation 1.1

Adverse Events

CHG 1 Min, CHG 2 Min, Comparator CHG

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

C. Beausoleil

BSL

Phone: 406-587-5735

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Data considered confidential
Publication restrictions are in place

Restriction type: OTHER