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Prevena device

Phase 1

Coronary Artery Disease | Unknown | Cardiovascular |3M Company|Last Updated: Dec 2, 2015

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindNO_TREATMENT_CONTROLLEDBiomarker
Total Trials1
Total Enrollment64

FDA Designations

No designations recorded

Clinical trial landscape

Prevena device · 1 trial · 3 indications

Phase 1 1
NCT01698372Negative Pressure Dressing After Saphenous Vein HarvestCoronary Artery Disease
COMPLETED64 Analytics
PHASE1COMPLETED
Negative Pressure Dressing After Saphenous Vein Harvest
Coronary Artery DiseaseUnlock trial analytics

Study Endpoints

Primary Endpoints

Change from baseline ASEPSIS score of wound healing at 6 weeks.
Baseline and 6 weeks

The ASEPSIS quantitative wound scoring method will be used to assess patients' leg wound healing after saphenous vein harvesting for coronary artery bypass surgery.

Secondary Endpoints

Total score of pain level.
Baseline and 6 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeSUPPORTIVE_CARE

Treatment Arms

ArmTypeDescription
Prevena device (Group A)EXPERIMENTALGroup A will have the VAC Prevena portable device applied to the saphenous vein harvest site after standard wound closure following coronary artery bypass surgery.
Conventional dressing (Group B)NO_INTERVENTIONGroup B will have conventional dry dressing applied to the saphenous vein harvest site after standard wound closure following coronary artery bypass surgery.

Interventions

NameTypeDescription
Prevena device (Group A)DEVICEThis portable device is applied to initiate negative pressure therapy to a wound site.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Patients presenting for elective or semi-elective isolated first-time CABG surgery with harvesting of the greater saphenous vein. * Must be 18 years or older. * Must live with one hour driving distance from Calgary. * Must provide written consent. Exclusion Criteria: * Previ...

Countries:Canada
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