The aim of the study is to evaluate participant reported quality of life, safety, and overall performance with ACTICOAT in a clinical setting.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
25
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.
Northumbria Healthcare NHS Foundation Trust
Ashington, United Kingdom
Leeds Wounds Research Unit
Leeds, United Kingdom
The Mid Yorkshire Hospitals NHS Trust
Wakefield, United Kingdom
Change in EQ-5D 5L mean single index utility scores (EuroQol Research Foundation 2015).
Time frame: 21 days
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
Time frame: 21 days
Wound length
Time frame: 21 days
Wound width
Time frame: 21 days
Wound depth
Time frame: 21 days
Reference wound healed (% re-epithelialized)
Time frame: 21 days
Amount of healthy tissue (% tissue types)
Time frame: 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
Time frame: 21 days
Extent of tissue staining
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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
Time frame: 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)
Time frame: 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).
Time frame: 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
Time frame: 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
Time frame: 21 days
Serious adverse events
Record of absolute number of serious adverse events observed in the study, together with associated details
Time frame: 21 days
Non-serious adverse events
Record of the absolute number of non-serious adverse events observed in the study, together with associated details
Time frame: 21 days
Device deficiencies
Record of the absolute number of device deficiencies observed in the study, together with associated details
Time frame: 21 days