Trial Outcomes & Findings for Preoperative Chlorhexidine Gluconate (CHG) Cloth on Healthy Subjects (NCT NCT02222896)

Results Overview

Percent of abdomen and groin sites that showed response (achieve a 2-Log and 3-Log reduction) respectively of bacterial flora from baseline. Note: the number of participants in each treatment group (abdomen and/or groin) can vary depending on whether participants achieved qualifying microbial levels.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

347 participants

Primary outcome timeframe

10 minutes, 6 hours, 8 hours

Results posted on

2021-05-21

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 4 sites. Differences in the number of participants is based on microbial qualification.

The sites of the participant were tested for microbial activity after product application. In some instances, more than one product could have been applied to a participant but only one product per site (groin and/or abdomen sites). Up to 4 sites could be treated: 1)both groin and abdomen, 2) only the groin or 3) only the abdomen.

Unit of analysis: Sites

Participant milestones

Participant milestones
Measure	CHG Cloth CHG 3 min application	Vehicle Vehicle, 3 min application	Comparator CHG CHG Comparator, 3 min application
Abdomen STARTED	253 253	48 48	253 253
Abdomen COMPLETED	219 219	38 38	221 221
Abdomen NOT COMPLETED	34 34	10 10	32 32
Groin STARTED	254 254	48 48	250 250
Groin COMPLETED	211 211	39 39	210 210
Groin NOT COMPLETED	43 43	9 9	40 40

Reasons for withdrawal

Reasons for withdrawal
Measure	CHG Cloth CHG 3 min application	Vehicle Vehicle, 3 min application	Comparator CHG CHG Comparator, 3 min application
Abdomen Did not qualify	34	10	32
Groin Did not qualify	43	9	40

Baseline Characteristics

Preoperative Chlorhexidine Gluconate (CHG) Cloth on Healthy Subjects

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	CHG, Vehicle, Comparator CHG n=347 Participants Single applications of products. 3 min application for CHG and Vehicle. Comparator CHG applied according to instructions.
Age, Categorical <=18 years	12 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	317 Participants n=5 Participants
Age, Categorical >=65 years	18 Participants n=5 Participants
Age, Continuous	35 years n=5 Participants
Sex: Female, Male Female	138 Participants n=5 Participants
Sex: Female, Male Male	209 Participants n=5 Participants
Region of Enrollment United States	347 participants n=5 Participants

PRIMARY outcome

Timeframe: 10 minutes, 6 hours, 8 hours

Population: Participants received product on up to 2 abdomen and 2 groin sites, 2 abdomen only sites or 2 groin sites only.

Percent of abdomen and groin sites that showed response (achieve a 2-Log and 3-Log reduction) respectively of bacterial flora from baseline. Note: the number of participants in each treatment group (abdomen and/or groin) can vary depending on whether participants achieved qualifying microbial levels.

Outcome measures

Outcome measures
Measure	CHG Cloth Abdomen n=253 Sites CHG 3 min application to abdomen	CHG Cloth Groin n=254 Sites CHG 3 min application to groin	Vehicle Abdomen n=48 Sites Vehicle 3 min application to abdomen	Vehicle Groin n=48 Sites Vehicle 3 min application to groin	Comparator CHG Abdomen n=253 Sites CHG comparator applied to abdomen	Comparator CHG Groin n=250 Sites CHG comparator applied to groin
Percent Responder Rates (%) of Bacterial Reduction on the Abdomen and Groin 8 hours	100 Percent of Sites	100 Percent of Sites	98 Percent of Sites	100 Percent of Sites	100 Percent of Sites	100 Percent of Sites
Percent Responder Rates (%) of Bacterial Reduction on the Abdomen and Groin 10 min	93 Percent of Sites	86 Percent of Sites	50 Percent of Sites	25 Percent of Sites	85 Percent of Sites	65 Percent of Sites
Percent Responder Rates (%) of Bacterial Reduction on the Abdomen and Groin 6 hours	100 Percent of Sites	100 Percent of Sites	98 Percent of Sites	100 Percent of Sites	100 Percent of Sites	100 Percent of Sites

Adverse Events

CHG Cloth

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Vehicle

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Comparative 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

Dr. Bashir

Microbac

Phone: 703-925-9366

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Confidential information based on contract.
Publication restrictions are in place

Restriction type: OTHER