AQUACEL® Ag+ Extra™ and Cutimed™ Sorbact® Dressing in the Management of Venous Leg Ulcers Over a 12-week Period
Study Details
Study Description
Brief Summary
Study is to provide evidence comparing AQUACEL® Ag+ Extra™ versus Cutimed® Sorbact® in the progression of wounds towards healing
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed 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
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: AQUACEL® Ag+ Extra™ AQUACEL® Ag+ Extra™ is approved, needle-bonded nonwoven fabric layered and stitch-bonded wound dressing |
Device: AQUACEL® Ag+ Extra™
Wound treatment with AQUACEL® Ag+ Extra™ dressing
|
| Active Comparator: Cutimed® Sorbact® Cutimed® Sorbact® is approved, bacterial and fungi binding wound dressing |
Device: Cutimed® Sorbact®
Wound treatment with Cutimed® Sorbact® dressing
|
Outcome Measures
Primary Outcome Measures
- Effectiveness of AQUACEL® Ag+ Extra™ and Cutimed® Sorbact® on wound management [Up to 12 weeks]
Complete wound closure as defined by 100% epithelialisation of the wound surface (Gould 2019)
Secondary Outcome Measures
- Wound healing assessment [Up to 4 weeks]
Percent change in study wound area
- Wound progress assessment [Up to 4 weeks]
Satisfactory clinical progress defined as 40% reduction in study wound area
- Wound change assessment [Up to 12 weeks]
Percent change in target wound area
- Safety assesment [Up to 12 weeks]
Summary of the incidence of adverse events (AEs), device-related AEs and serious device-related AEs
Other Outcome Measures
- Pain assessment [Up to 12 weeks]
Numeric Rating Scale from 0 to 10
- Quality of Life assesment [Up to 12 weeks]
Wound-QoL-14 global score
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Convatec Colombia Clinic | Barranquilla | Colombia | ||
| 2 | Convatec Colombia Clinic | Bogotá | Colombia | ||
| 3 | Convatec Colombia Clinic | Bucaramanga | Colombia | ||
| 4 | Convatec Colombia Clinic | Cali | Colombia | ||
| 5 | Convatec Colombia Clinic | Cartagena | Colombia | ||
| 6 | Convatec Colombia Clinic | Medellín | Colombia | ||
| 7 | Convatec Germany Clinic | Berlin | Germany | ||
| 8 | Convatec Germany Clinic | Bochum | Germany | ||
| 9 | Convatec Germany Clinic | Buchholz | Germany | ||
| 10 | Convatec Germany Clinic | Düsseldorf | Germany | ||
| 11 | Convatec Germany Clinic | Ratzeburg | Germany | ||
| 12 | Convatec Germany Clinic | Wernigerode | Germany | ||
| 13 | Convatec Poland Clinic | Lublin | Poland | ||
| 14 | Convatec UK Clinic | Derby | United Kingdom |
Sponsors and Collaborators
- ConvaTec Inc.
- NAMSA
Investigators
- Principal Investigator: Catarina Saavedra, MD, Convatec Colombia Clinic
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- WC-22-435