AQUACEL® Ag+ Extra™ and Cutimed™ Sorbact® Dressing in the Management of Venous Leg Ulcers Over a 12-week Period

Convatec

Status: Completed

Conditions: Venous Leg Ulcer; Diabetic Foot

Treatments: Device: Cutimed® Sorbact®; Device: AQUACEL® Ag+ Extra™

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05892341

WC-22-435

Details and patient eligibility

About

Study is to provide evidence comparing AQUACEL® Ag+ Extra™ versus Cutimed® Sorbact® in the progression of wounds towards healing

Full description

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

Enrollment: 205 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Venous insufficiency as defined by CEAP Classification of C6
• One wound amendable to treatment with either AQUACEL® Ag+ Extra™ or Cutimed® Sorbact®
• Wounds that have been present for at least 2 months
• Reliable and available for follow-up
• 18 years or older
• Able and willing to provide informed consent
• Able to tolerate compression therapy for Venus Leg Ulcer
• Must be able to be compliant with compression therapy

Exclusion criteria

• Known sensitivities or allergies to components of the AQUACEL® Ag+ Extra™ or Cutimed® Sorbact®
• Continued use of petroleum gel/ creams/ oil-based products
• Active treatment for cancer or completed within the last 3 months
• Documented severe malnutrition
• Malignant wounds
• Systemic infection actively treated with antibiotics

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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205 participants in 2 patient groups

AQUACEL® Ag+ Extra™

Active Comparator group

Description:

AQUACEL® Ag+ Extra™ is approved, needle-bonded nonwoven fabric layered and stitch-bonded wound dressing

Treatment:

Device: AQUACEL® Ag+ Extra™

Cutimed® Sorbact®

Active Comparator group

Description:

Cutimed® Sorbact® is approved, bacterial and fungi binding wound dressing

Treatment:

Device: Cutimed® Sorbact®