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Chlorhexidine Gluconate

Phase 3

Surgery | Small molecule | Other |Medline Inc.|Last Updated: Dec 15, 2023

Success Probability
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Market & Valuation
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Trial Design
RandomizedPLACEBO_CONTROLLED
Total Trials3
Total Enrollment1,566
FDA Designations
No designations recorded
Clinical trial landscape

Chlorhexidine Gluconate · 4 trials · 2 indications

Phase 3 3Phase 1 1
NCT02526667Preoperative Chlorhexidine Gluconate (CHG) Cloth on Healthy VolunteersSurgery
COMPLETED340 Analytics
NCT02291601Preoperative CHG Cloth on Healthy SubjectsSurgery
COMPLETED879 Analytics
NCT02222896Preoperative Chlorhexidine Gluconate (CHG) Cloth on Healthy SubjectsSurgery
COMPLETED347 Analytics
PHASE3COMPLETED
Preoperative Chlorhexidine Gluconate (CHG) Cloth on Healthy Volunteers
SurgeryUnlock trial analytics
PHASE3COMPLETED
Preoperative CHG Cloth on Healthy Subjects
SurgeryUnlock trial analytics
PHASE3COMPLETED
Preoperative Chlorhexidine Gluconate (CHG) Cloth on Healthy Subjects
SurgeryUnlock trial analytics
Study Endpoints
Primary Endpoints
Responder Rates (%) of Sites Identified for Bacterial Reduction on the Abdomen and Groin
10 minutes, 6 hours, 8 hours

Log10 reduction in bacteria on the skin evaluated at 10 minutes, 6 hours and 8 hours after treatment. Responder rates (%) are the percentage of sites identified that produced a 2-Log and 3-Log reduction from baseline for abdomen and groin sites respectively.

Percent Responder Rates of Bacterial Reduction on the Abdomen and Groin Sites
10 minutes to 8 hours

Percent of abdomen and groin sites that achieve a 2-Log or 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 on the abdomen and groin at baseline.

Percent Responder Rates (%) of Bacterial Reduction on the Abdomen and Groin
10 minutes, 6 hours, 8 hours

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.

Number of Subjects With Plasma Levels of Chlorexidine Following Systemic Exposure After a Single Topical Application of CHG.
Up to 24 hours after product application

A total of 12 blood samples were collected (one tube of 6 mL each) at various time points up before and after product application in each study period and analyzed for plasma levels of chlorhexidine. Blood samples were collected at 10, 2 and 0.5 hours prior to each treatment, and 1, 2, 3, 4, 5, 6, 8, and 12 hours following each treatment.

Secondary Endpoints
Number of Subjects With of Treatment Emergent Adverse Events.
Up to 24 hours after product application, overall, up to 3 weeks
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Study Design & Arms
AllocationRANDOMIZED
MaskingSINGLE
ModelPARALLEL
PurposePREVENTION
Treatment Arms
ArmTypeDescription
Chlorhexidine Gluconate ClothEXPERIMENTAL2% CHG, single application
Vehicle ClothPLACEBO_COMPARATORExcipients on cloth
Active Chlorhexidine gluconate solutionACTIVE_COMPARATORDynahex 2% CHG
Abdominal application of 2% CHGEXPERIMENTAL -
Groin application of 2% CHGEXPERIMENTAL -
Control treatment with no applicationNO_INTERVENTION -
Interventions
NameTypeDescription
Chlorhexidine gluconateDRUG2% CHG solution on cloth
DynaHex-2DRUG2% CHG solution
VehicleOTHERExcipients of CHG product only
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Eligibility Criteria
Age Range18 Years to N/A
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Males or Females * 18 years of age or older * Signed informed consent * Good Health * Six inches of abdomen and groin areas without tattoos, or skin disorders Exclusion Criteria: * Dermatological Conditions * Sensitivity to latex * Sensitivity to CHG

Countries:RomaniaUnited States
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