Study is to provide evidence comparing AQUACEL® Ag+ Extra™ versus Cutimed® Sorbact® in the progression of wounds towards healing
Post market, multi-centre, randomised, open label, multi-national, prospective study to provide evidence comparing AQUACEL® Ag+ Extra™ versus Cutimed® Sorbact® in the progression of wounds towards healing
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
203
Wound treatment with AQUACEL® Ag+ Extra™ dressing
Wound treatment with Cutimed® Sorbact® dressing
Convatec Colombia Clinic
Barranquilla, Colombia
Convatec Colombia Clinic
Bogotá, Colombia
Convatec Colombia Clinic
Bucaramanga, Colombia
Effectiveness of AQUACEL® Ag+ Extra™ and Cutimed® Sorbact® on Wound Management
Complete wound closure as defined by 100% epithelialisation of the wound surface (Gould 2019)
Time frame: Up to 12 weeks
Wound Healing Assessment
Percent change in study wound area
Time frame: Up to 4 weeks
Wound Progress Assessment
Satisfactory clinical progress defined as 40% reduction in study wound area
Time frame: Up to 4 weeks
Wound Change Assessment
Percent change in target wound area
Time frame: Up to 12 weeks
Safety Assesment
Summary of the incidence of adverse events (AEs), device-related adverse events (ADEs) and serious device-related adverse events (SADEs)
Time frame: Up to 12 weeks
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Convatec Colombia Clinic
Cali, Colombia
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...and 8 more locations