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Aquacel Ag Gelled, Aquacel Ag Adherent

Phase 3

Split-Thickness Donor Sites. | Unknown | Other |Bristol-Myers Squibb Company|Last Updated: Feb 3, 2009

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
RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment73
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00731367Comparative Evaluation of Two AQUACEL Ag Protocols of Care for the Management of Donor SitesPHASE3 COMPLETED 73Oct 1, 2005Aug 1, 2006Feb 3, 20091 United States
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Study Endpoints
Primary Endpoints
To evaluate the proportion of subjects healed.
14 days
Secondary Endpoints
Time to healing.
14 days
Degree of pain at dressing change.
14 days
Degree of pain/discomfort while wearing the dressing at rest and during mobility.
14 days
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
GelledACTIVE_COMPARATORAquacel Ag gelled.
AdherentACTIVE_COMPARATORAquacel Ag adherent
Interventions
NameTypeDescription
Aquacel Ag GelledDEVICEAQUACEL Ag is produced by changing a small fraction of the sodium ions present in AQUACEL for silver ions and then stabilizing the complex formed by adding chloride. This produces a characteristic silver gray product. There are no counter ions (such as nitrate or sulphadiazine ions) present: these compounds, found in many silver containing products, are known to retard wound healing. AQUACEL Ag maintains a moist wound-healing environment while, at the same time, killing wound pathogens that are immobilized within the dressing. It also reduces bioburden at the wound-dressing surface, thus minimizing the risk of wound infection and facilitating wound healing.
Aquacel Ag AdherentDEVICEAQUACEL Ag is produced by changing a small fraction of the sodium ions present in AQUACEL for silver ions and then stabilizing the complex formed by adding chloride. This produces a characteristic silver gray product. There are no counter ions (such as nitrate or sulphadiazine ions) present: these compounds, found in many silver containing products, are known to retard wound healing. AQUACEL Ag maintains a moist wound-healing environment while, at the same time, killing wound pathogens that are immobilized within the dressing. It also reduces bioburden at the wound-dressing surface, thus minimizing the risk of wound infection and facilitating wound healing.
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Eligibility Criteria
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Subject or legally authorized representative must provide written informed consent. * Subject who is younger than legal consenting age must have a legally authorized representative who will provide written informed consent. * The subject is scheduled to undergo a split-thickne...

Countries:United States
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