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| Name | Class |
|---|---|
| NAMSA | OTHER |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AQUACEL® Ag+ Extra™ | Active Comparator | AQUACEL® Ag+ Extra™ is approved, needle-bonded nonwoven fabric layered and stitch-bonded wound dressing |
|
| Cutimed® Sorbact® | Active Comparator | Cutimed® Sorbact® is approved, bacterial and fungi binding wound dressing |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AQUACEL® Ag+ Extra™ | Device | Wound treatment with AQUACEL® Ag+ Extra™ dressing |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Up to 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Wound Healing Assessment | Percent change in study wound area | Up to 4 weeks |
| Wound Progress Assessment | Satisfactory clinical progress defined as 40% reduction in study wound area |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Catarina Saavedra, MD | Convatec Colombia Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Convatec Colombia Clinic | Barranquilla | Colombia | ||||
| Convatec Colombia Clinic |
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| ID | Title | Description |
|---|---|---|
| FG000 | AQUACEL® Ag+ Extra™ | AQUACEL® Ag+ Extra™ is approved, needle-bonded nonwoven fabric layered and stitch-bonded wound dressing AQUACEL® Ag+ Extra™: Wound treatment with AQUACEL® Ag+ Extra™ dressing |
| FG001 | Cutimed® Sorbact® |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 16, 2023 |
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| Cutimed® Sorbact® |
| Device |
Wound treatment with Cutimed® Sorbact® dressing |
|
| Up to 4 weeks |
| Wound Change Assessment | Percent change in target wound area | 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) | Up to 12 weeks |
| Bogotá |
| Colombia |
| Convatec Colombia Clinic | Bucaramanga | Colombia |
| Convatec Colombia Clinic | Cali | Colombia |
| Convatec Colombia Clinic | Cartagena | Colombia |
| Convatec Colombia Clinic | Medellín | Colombia |
| Germany | Augsburg | Germany |
| Germany | Berlin | Germany |
| Germany | Bochum | Germany |
| Germany | Düsseldorf | Germany |
| Germany | Holzkirchen | Germany |
| Germany | Ingolstadt | Germany |
| Germany Clinic II | München | Germany |
| Germany Clinic I | München | Germany |
| Germany | Nuremberg | Germany |
| Germany | Ratzeburg | Germany |
| Germany | Rosenheim | Germany |
| VCTC UK | Derby | United Kingdom |
Cutimed® Sorbact® is approved, bacterial and fungi binding wound dressing
Cutimed® Sorbact®: Wound treatment with Cutimed® Sorbact® dressing
| COMPLETED |
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| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | AQUACEL® Ag+ Extra™ | AQUACEL® Ag+ Extra™ is approved, needle-bonded nonwoven fabric layered and stitch-bonded wound dressing AQUACEL® Ag+ Extra™: Wound treatment with AQUACEL® Ag+ Extra™ dressing |
| BG001 | Cutimed® Sorbact® | Cutimed® Sorbact® is approved, bacterial and fungi binding wound dressing Cutimed® Sorbact®: Wound treatment with Cutimed® Sorbact® dressing |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Age years, Categorical | Count of Participants | Participants |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
| |||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
| ||||||||||||||||
| BMI | Mean | Standard Deviation | kg/m2 |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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) | Proportion of study wounds with complete wound healing by Week 12 | Posted | Count of Units | Number of Wounds | Up to 12 weeks | Number of Wounds | Number of Wounds |
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| |||||||||||||||||||||||||||||
| Secondary | Wound Healing Assessment | Percent change in study wound area | Percent change in wound size at Week 4 | Posted | Mean | Standard Deviation | Percent change in wound size | Up to 4 weeks | Number of Wounds | Number of Wounds |
|
| |||||||||||||||||||||||||||||
| Secondary | Wound Progress Assessment | Satisfactory clinical progress defined as 40% reduction in study wound area | Proportion of study wounds with satisfactory clinical progress defined as 40% reduction in study wound area at 4 weeks | Posted | Number | 95% Confidence Interval | Number of Wounds | Up to 4 weeks | Number of Wounds | Number of Wounds |
|
| |||||||||||||||||||||||||||||
| Secondary | Wound Change Assessment | Percent change in target wound area | Percent change in wound size at Week 12 | Posted | Mean | Standard Deviation | Percent change in wound size | Up to 12 weeks | Number of Wounds | Number of Wounds |
|
| |||||||||||||||||||||||||||||
| Secondary | Safety Assesment | Summary of the incidence of adverse events (AEs), device-related adverse events (ADEs) and serious device-related adverse events (SADEs) | Proportion of subjects with AEs, SAEs, ADEs and Unanticipated Adverse Device Effects | Posted | Number | participants | Up to 12 weeks |
|
|
Adverse events (AEs), Serious Adverse events (SAEs), Adverse Device Effects (ADEs), Serious Adverse Device Effects (SADEs), Unanticipated Serious Adverse Device Effects (UADEs) and Device deficiencies were recorded throughout the study duration up to 84 days (±2 days).
The definitions of each type of these events, instructions for causality assessment (i.e., determination of relationship of the event to the study device or study procedure), categories of severity (mild, moderate, or severe) of events, and procedure for monitoring and recording of events were provided in the study Protocol.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | AQUACEL® Ag+ Extra™ | AQUACEL® Ag+ Extra™ is approved, needle-bonded nonwoven fabric layered and stitch-bonded wound dressing AQUACEL® Ag+ Extra™: Wound treatment with AQUACEL® Ag+ Extra™ dressing | 0 | 101 | 3 | 101 | 8 | 101 |
| EG001 | Cutimed® Sorbact® | Cutimed® Sorbact® is approved, bacterial and fungi binding wound dressing Cutimed® Sorbact®: Wound treatment with Cutimed® Sorbact® dressing | 1 | 102 | 6 | 102 | 21 | 102 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ischaemic heart disease | Cardiac disorders | Systematic Assessment |
| ||
| Gastrointestinal bleeding | Gastrointestinal disorders | Systematic Assessment |
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| Death | General disorders | Systematic Assessment |
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| Allergic reaction to drug | Immune system disorders | Systematic Assessment |
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| Cellulitis on left lower leg | Infections and infestations | Systematic Assessment |
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| Chest infection | Infections and infestations | Systematic Assessment |
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| UTI | Infections and infestations | Systematic Assessment |
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| Unspecified local infection of skin and subcutaneous tissue | Infections and infestations | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Wound infection | Infections and infestations | Systematic Assessment |
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| UTI | Infections and infestations | Systematic Assessment |
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| Ulcer bleeding | General disorders | Systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | Systematic Assessment |
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| Overgranulation | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Unilateral leg swelling | General disorders | Systematic Assessment |
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| Infection | Infections and infestations | Systematic Assessment |
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| Thrush | Infections and infestations | Systematic Assessment |
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| Thumb osteoarthritis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Leg ulcer (not study ulcer) | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Wound pain | Injury, poisoning and procedural complications | Systematic Assessment | Increase in pain associated with right leg ulcer |
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| Open wound | Injury, poisoning and procedural complications | Systematic Assessment | Open wound great toe right foot |
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| Itching all over | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Ulcer | General disorders | Systematic Assessment |
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| Pressure ulcer | Skin and subcutaneous tissue disorders | Systematic Assessment | Suspected deep tissue injury |
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| Cellulitis of abdominal wall | Infections and infestations | Systematic Assessment |
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| Hypercholesterolemia | Metabolism and nutrition disorders | Systematic Assessment |
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| Venous ulcer recurrent | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Infected skin ulcer | Infections and infestations | Systematic Assessment |
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| Varicose veins of lower extremities with ulcer | Vascular disorders | Systematic Assessment |
| ||
| Wound | Infections and infestations | Systematic Assessment | Wound in the neck of the foot |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Cristin Taylor, Senior Director, Medical Affairs, Advanced Wound Care | ConvaTec Inc. | 1-800-422-8811 | cristin.taylor@convatec.com |
| Jul 9, 2025 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D014647 | Varicose Ulcer |
| D017719 | Diabetic Foot |
| ID | Term |
|---|---|
| D014648 | Varicose Veins |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D007871 | Leg Ulcer |
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D003925 | Diabetic Angiopathies |
| D016523 | Foot Ulcer |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D003929 | Diabetic Neuropathies |
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| 65-79 |
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| 80+ |
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| United Kingdom |
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| Germany |
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| Number of Wounds |
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| Number of Wounds |
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| Number of Wounds |
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