Clinical trial NCT02852148: ACTICOAT™ for the Treatment of Burns and Chronic Wounds
Official title: A Prospective, Non-comparative, Multicentre Study to Evaluate a Silver Coated Antimicrobial Barrier Wound Dressing (ACTICOAT™) in the Treatment of Burns and Chronic Wounds.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Wounds and Injuries
Burns
Pressure Ulcer
Foot Ulcer
Keywords: Wound
Pressure Ulcer
Diabetic Foot Ulcer
Venous Leg Ulcer
Burn
Quality of Life
Lead sponsor: Smith & Nephew, Inc.
Sponsor class: INDUSTRY
First posted: 2016-08-02
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: INCLUSION CRITERIA

1. Must provide informed consent to participate in the study.
2. Eighteen (18) years of age or older.
3. Males and females.
4. Able to follow instructions and be deemed capable of completing the EQ-5D 5L Questionnaire appropriately.
5. Willing and able to make all required study visits, and provide a daytime telephone number on which they can be contacted directly.
6. Presenting with either a chronic wound or burn which is deemed suitable for treatment with ACTICOAT and meets either of the following requirements:

   1. 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.
   2. 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

1. Contraindications or hypersensitivity to the use of the test article, ancillary products or their components (e.g., known sensitivity to silver).
2. Participation in the treatment period of another clinical trial within thirty (30) days of Visit 1.
3. Treatment with any other silver dressing (i.e. non ACTICOAT dressing) within seven (7) days of Visit 1.
4. Patients with skin features which in the opinion of the Investigator, will interfere with the study assessments.
5. Patients requiring concomitant use of NPWT on the reference wound.
6. Patients who have participated previously in this clinical trial and who have healed or been withdrawn.
7. Patients with a history of poor compliance with medical treatment.
8. Patients who, in the opinion of the Investigator, are experiencing burn shock.
9. Patients with any other medical or physical condition that, in the opinion of the Investigator, would preclude safe subject participation in the study.

Primary outcomes:
measure: Change in EQ-5D 5L mean single index utility scores (EuroQol Research Foundation 2015).
timeFrame: 21 days
Secondary outcomes:
measure: Clinical signs and symptoms of infection
timeFrame: 21 days
measure: Wound length
timeFrame: 21 days
measure: Wound width
timeFrame: 21 days
measure: Wound depth
timeFrame: 21 days
measure: Reference wound healed (% re-epithelialized)
timeFrame: 21 days
measure: Amount of healthy tissue (% tissue types)
timeFrame: 21 days
measure: Condition of surrounding skin
timeFrame: 21 days
measure: Extent of tissue staining
timeFrame: 21 days
measure: Pain on dressing application
timeFrame: 21 days
measure: Pain on dressing removal
timeFrame: 21 days
measure: Ease of dressing application
timeFrame: 21 days
measure: Ease of dressing removal
timeFrame: 21 days
measure: Serious adverse events
timeFrame: 21 days
measure: Non-serious adverse events
timeFrame: 21 days
measure: Device deficiencies
timeFrame: 21 days
Other outcomes:
Locations:
city: Ashington
country: United Kingdom
facility: Northumbria Healthcare NHS Foundation Trust
city: Leeds
country: United Kingdom
facility: Leeds Wounds Research Unit
city: Wakefield
country: United Kingdom
facility: The Mid Yorkshire Hospitals NHS Trust
Study officials:
affiliation: Smith & Nephew, Inc.
name: Beate Hanson, VP, PhD
role: STUDY_CHAIR
affiliation: Pinderfield Hospitals
name: Lyn Wilson, MA
role: PRINCIPAL_INVESTIGATOR
References: