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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

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment73

FDA Designations

No designations recorded

Clinical trial landscape

Aquacel Ag Gelled, Aquacel Ag Adherent · 1 trial · 1 indication

Phase 3 1
NCT00731367Comparative Evaluation of Two AQUACEL Ag Protocols of Care for the Management of Donor SitesSplit-Thickness Donor Sites.
COMPLETED73 Analytics
PHASE3COMPLETED
Comparative Evaluation of Two AQUACEL Ag Protocols of Care for the Management of Donor Sites
Split-Thickness Donor Sites.Unlock trial analytics

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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Frequently asked questions about Aquacel Ag Gelled, Aquacel Ag Adherent

What is Aquacel Ag Gelled used for?

Aquacel Ag Gelled is used for the management of split-thickness donor sites, which are areas of skin harvested for grafting. It is a wound care product designed to be applied to these sites to support healing. The product is currently in Phase 3 clinical development for this indication.

What is Aquacel Ag Adherent used for?

Aquacel Ag Adherent is used for the management of split-thickness donor sites, which are areas of skin harvested for grafting. It is a wound care product designed to be applied to these sites to support healing. The product is currently in Phase 3 clinical development for this indication.

Who makes Aquacel Ag Gelled?

Aquacel Ag Gelled is developed by Bristol-Myers Squibb Company, which trades under the ticker BMY. The company is conducting clinical trials to evaluate the product for the management of split-thickness donor sites.

Who makes Aquacel Ag Adherent?

Aquacel Ag Adherent is developed by Bristol-Myers Squibb Company, which trades under the ticker BMY. The company is conducting clinical trials to evaluate the product for the management of split-thickness donor sites.

What phase is Aquacel Ag Gelled in?

Aquacel Ag Gelled is in Phase 3 clinical development. It is being studied for the management of split-thickness donor sites. The product is investigational and has not been approved by regulatory authorities based on the available information.

What phase is Aquacel Ag Adherent in?

Aquacel Ag Adherent is in Phase 3 clinical development. It is being studied for the management of split-thickness donor sites. The product is investigational and has not been approved by regulatory authorities based on the available information.