ACTICOAT™ for the Treatment of Burns and Chronic Wounds
- Conditions
- Pressure UlcerFoot UlcerBurnsWounds and Injuries
- Interventions
- Device: ACTICOAT
- Registration Number
- NCT02852148
- Lead Sponsor
- Smith & Nephew, Inc.
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 25
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description ACTICOAT ACTICOAT 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.
- Primary Outcome Measures
Name Time Method Change in EQ-5D 5L mean single index utility scores (EuroQol Research Foundation 2015). 21 days
- Secondary Outcome Measures
Name Time Method Wound length 21 days Wound depth 21 days Amount of healthy tissue (% tissue types) 21 days Ease of dressing removal 21 days 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
Serious adverse events 21 days Record of absolute number of serious adverse events observed in the study, together with associated details
Clinical signs and symptoms of infection 21 days 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
Wound width 21 days Condition of surrounding skin 21 days 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
Extent of tissue staining 21 days 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
Pain on dressing application 21 days 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)
Non-serious adverse events 21 days Record of the absolute number of non-serious adverse events observed in the study, together with associated details
Reference wound healed (% re-epithelialized) 21 days Pain on dressing removal 21 days 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).
Ease of dressing application 21 days 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
Device deficiencies 21 days Record of the absolute number of device deficiencies observed in the study, together with associated details
Trial Locations
- Locations (3)
Leeds Wounds Research Unit
🇬🇧Leeds, United Kingdom
The Mid Yorkshire Hospitals NHS Trust
🇬🇧Wakefield, United Kingdom
Northumbria Healthcare NHS Foundation Trust
🇬🇧Ashington, United Kingdom