ACTICOAT™ for the Treatment of Burns and Chronic Wounds

Burns Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02852148
• Other study ID #: CT1601ACT
• Status: Completed
• Phase: N/A
• Start date: November 2016
• Est. completion date: December 13, 2017

Study information

• Verified date: April 2019
• Source: Smith & Nephew, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: December 13, 2017
• Est. primary completion date: November 28, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Burns
• Foot Ulcer
• Pressure Ulcer
• Ulcer
• Wounds and Injuries

Intervention

Device:
• 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.

Locations

Country	Name	City	State
United Kingdom	Northumbria Healthcare NHS Foundation Trust	Ashington
United Kingdom	Leeds Wounds Research Unit	Leeds
United Kingdom	The Mid Yorkshire Hospitals NHS Trust	Wakefield

Sponsors (1)

Lead Sponsor	Collaborator
Smith & Nephew, Inc.

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in EQ-5D 5L mean single index utility scores (EuroQol Research Foundation 2015).		21 days
Secondary	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
Secondary	Wound length		21 days
Secondary	Wound width		21 days
Secondary	Wound depth		21 days
Secondary	Reference wound healed (% re-epithelialized)		21 days
Secondary	Amount of healthy tissue (% tissue types)		21 days
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Serious adverse events	Record of absolute number of serious adverse events observed in the study, together with associated details	21 days
Secondary	Non-serious adverse events	Record of the absolute number of non-serious adverse events observed in the study, together with associated details	21 days
Secondary	Device deficiencies	Record of the absolute number of device deficiencies observed in the study, together with associated details	21 days