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Chlorhexidine gluconate

Phase 2

Catheterization | Small molecule | Other |Solventum Corporation|Last Updated: Oct 24, 2024

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedPLACEBO_CONTROLLED
Total Trials1
Total Enrollment68
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00516906Clinical Performance of a Chlorhexidine Antimicrobial DressingPHASE2 COMPLETED 68Oct 1, 2007Jan 1, 2008Oct 24, 2024 -
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Study Endpoints
Primary Endpoints
Clinician Overall Satisfaction With Catheter Securement
Daily up to 7 Days (average 3-7 days of wear)

Clinician Overall Satisfaction with Catheter Securement Five Point Scale: 1 = Very Good, 5= Very Poor

Secondary Endpoints
Clinician Overall Satisfaction With Dressing
Daily up to 7 Days (average 3-7 days of wear)
Rating of Skin Condition
Daily up to 7 Days (average 3-7 days of wear)
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Study Design & Arms
AllocationRANDOMIZED
MaskingSINGLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Transparent Adhesive DressingPLACEBO_COMPARATORStandard of Care Non-Antimicrobial Transparent Adhesive Dressing
CHG antimicrobial transparent dressingEXPERIMENTALChlorhexidine gluconate antimicrobial transparent adhesive dressing
Interventions
NameTypeDescription
Chlorhexidine gluconateDRUG2% Chlorhexidine Transparent Dressing applied as needed up to 7 days of wear
Transparent Adhesive DressingDRUGStandard of Care Non-antimicrobial Transparent Adhesive Dressing applied as needed for up to 7 days of wear
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Males or Females over 18 years of age * Patients with an existing, or newly inserted, central venous catheter * Patients who require the catheter for at least 3 days Exclusion Criteria: * Sensitivity to chlorhexidine

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