ACTICOAT™ for the Treatment of Burns and Chronic Wounds

Study Overview
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Brief Summary
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The aim of the study is to evaluate participant reported quality of life, safety, and overall performance with ACTICOAT in a clinical setting.

Detailed Description
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ACTICOAT is a silver coated antimicrobial barrier wound dressing for the treatment of a variety of wound types. It is widely used in routine clinical practice within the UK. ACTICOAT is CE marked and will be used within the intended indications for use. The proposed study is required for regulatory purposes. Primary Objective: To evaluate change in health related quality of life, associated with treatment. The primary outcome measure / endpoint will be change in EQ-5D 5L mean single index utility scores from baseline to 3 weeks. The study will also seek to gather and report relevant safety and performance data and evaluate change, where applicable, for outcomes including: clinical signs and symptoms of infection; wound length / width / depth; wound healing measures; tissue staining; pain, adherence, and pain on application / removal; wear time; adverse events and device deficiencies. In total 25 participants will be recruited into the trial, comprising a minimum of 8 participants with a full or partial thickness burn and a minimum of 8 participants with a full or partial thickness chronic wound. All participants will have their wound dressed using ACTICOAT, and will be followed-up for 3 weeks.

Official Title
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A Prospective, Non-comparative, Multicentre Study to Evaluate a Silver Coated Antimicrobial Barrier Wound Dressing (ACTICOAT™) in the Treatment of Burns and Chronic Wounds.

Conditions
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Burns, Wounds and Injuries, Pressure Ulcer, Foot Ulcer

Intervention / Treatment
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* Device: ACTICOAT


Participation Criteria
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Eligibility Criteria
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INCLUSION CRITERIA Must provide informed consent to participate in the study. Eighteen (18) years of age or older. Males and females. Able to follow instructions and be deemed capable of completing the EQ-5D 5L Questionnaire appropriately. Willing and able to make all required study visits, and provide a daytime telephone number on which they can be contacted directly. Presenting with either a chronic wound or burn which is deemed suitable for treatment with ACTICOAT and meets either of the following requirements: A full or partial thickness chronic (≥ 4 weeks duration) wound, consisting of a Venous Leg Ulcer, Pressure Ulcer or Diabetic Foot Ulcer, which in the opinion of the Investigator, or delegated Sub-Investigator, appears to be infected based on documented clinical signs and symptoms of infection. A recently acquired (≤ 7 days) non-infected burn, comprising a full or partial thickness wound, covering a minimum 0.5% TBSA. The maximum must be less than 10% TBSA. Absence of infection will be determined by the Investigator / Sub-Investigator. EXCLUSION CRITERIA Contraindications or hypersensitivity to the use of the test article, ancillary products or their components (e.g., known sensitivity to silver). Participation in the treatment period of another clinical trial within thirty (30) days of Visit 1. Treatment with any other silver dressing (i.e. non ACTICOAT dressing) within seven (7) days of Visit 1. Patients with skin features which in the opinion of the Investigator, will interfere with the study assessments. Patients requiring concomitant use of NPWT on the reference wound. Patients who have participated previously in this clinical trial and who have healed or been withdrawn. Patients with a history of poor compliance with medical treatment. Patients who, in the opinion of the Investigator, are experiencing burn shock. Patients with any other medical or physical condition that, in the opinion of the Investigator, would preclude safe subject participation in the study.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ACTICOAT<br>ACTICOAT is a silver coated antimicrobial barrier dressing. ACTICOAT dressings consist of three layers: an absorbent inner core of polyester and rayon sandwiched between outer layers of silver coated, low adherent, high density polyethylene mesh. | Device: ACTICOAT<br>* ACTICOAT is a silver coated antimicrobial barrier dressing. ACTICOAT dressings consist of three layers: an absorbent inner core of polyester and rayon sandwiched between outer layers of silver coated, low adherent, high density polyethylene mesh.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in EQ-5D 5L mean single index utility scores (EuroQol Research Foundation 2015). |  | 21 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical signs and symptoms of infection | Wound infection checklist. Simple checklist consisting of thirteen separate 'observable signs of critical colonisation or infection at the reference wound', namely: 'Wound static or deteriorating'; 'Increased exudate/secretion levels'; 'Increased temperature around wound'; 'Discoloration of granulation tissue'; 'Increased pain'; 'Tissue necrosis'; 'Oedema'; 'Dehiscence'; 'Friable granulation'; 'Local erythema'; 'Purulent drainage'; 'Odour'; 'Other'. Total scale score = the sum of checked items, ranging from 0 to 13 | 21 days | 
| Wound length |  | 21 days | 
| Wound width |  | 21 days | 
| Wound depth |  | 21 days | 
| Reference wound healed (% re-epithelialized) |  | 21 days | 
| Amount of healthy tissue (% tissue types) |  | 21 days | 
| Condition of surrounding skin | Condition of surround skin checklist. Simple checklist consisting of six items used to document the 'condition of the surrounding skin' around the wound, namely: 'Healthy'; 'Fragile'; 'Inflamed'; 'Macerated'; 'Dry and flaky'; 'Other'. No summation of items | 21 days | 
| Extent of tissue staining | Tissue staining checklist. Simple checklist for documenting any observed instances and 'Extent of tissue staining' following use of the dressing, and consisting of four items, namely: 'None'; 'Slight'; 'Moderate'; and 'Extensive'. No summation of items | 21 days | 
| Pain on dressing application | Pain/stinging Likert scale for dressing application. Eleven point Likert scale for use in recording 'Level of pain/stinging experienced by the subject on application of the ACTICOAT dressing(s)', ranging from 0 (no pain/stinging) to 10 (extreme pain/stinging) | 21 days | 
| Pain on dressing removal | Pain Likert scale for dressing removal. Eleven point Likert scale for use in recording 'Level of pain experienced by the subject on removal of the ACTICOAT dressing(s)', ranging from 0 (no pain) to 10 (extreme pain). | 21 days | 
| Ease of dressing application | Ease of dressing application question. Single item asking 'Was it easy to apply the ACTICOAT dressing(s)?', with a simple response format of 'Yes' or 'No - please give reason', accompanied by a further free text response option for reason(s) why the dressing was not easy to apply | 21 days | 
| Ease of dressing removal | Ease of dressing removal question. Single item asking 'Was the ACTICOAT dressing easy to remove?', with a simple response format of 'Yes' or 'No - please explain', accompanied by a further free text response option for reason(s) why the dressing was not easy to remove | 21 days | 
| Serious adverse events | Record of absolute number of serious adverse events observed in the study, together with associated details | 21 days | 
| Non-serious adverse events | Record of the absolute number of non-serious adverse events observed in the study, together with associated details | 21 days | 
| Device deficiencies | Record of the absolute number of device deficiencies observed in the study, together with associated details | 21 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Burn, Wound, Pressure Ulcer, Diabetic Foot Ulcer, Venous Leg Ulcer, Quality of Life