ACTICOAT™ for the Treatment of Burns and Chronic Wounds

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

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

Study Overview

• Status: Completed
• Conditions: Wounds and Injuries; Burns; Foot Ulcer; Pressure Ulcer
• Intervention / Treatment: Device: ACTICOAT

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.

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Ashington, United Kingdom, NE630HP
    • Northumbria Healthcare NHS Foundation Trust
  • Leeds, United Kingdom, LS12 3QE
    • Leeds Wounds Research Unit
  • Wakefield, United Kingdom, WF1 4EE
    • The Mid Yorkshire Hospitals NHS Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Smith & Nephew, Inc.
• Investigators: Study Chair: Beate Hanson, VP, PhD, Smith & Nephew, Inc.; Principal Investigator: Lyn Wilson, MA, Pinderfield Hospitals

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2016
• Primary Completion (Actual): November 28, 2017
• Study Completion (Actual): December 13, 2017

Study Registration Dates

• First Submitted: June 24, 2016
• First Submitted That Met QC Criteria: July 28, 2016
• First Posted (Estimate): August 2, 2016

Study Record Updates

• Last Update Posted (Actual): April 4, 2019
• Last Update Submitted That Met QC Criteria: April 2, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: Quality of Life; Wound; Diabetic Foot Ulcer; Pressure Ulcer; Burn; Venous Leg Ulcer
• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Leg Ulcer; Skin Ulcer; Foot Diseases; Burns; Foot Ulcer; Ulcer; Wounds and Injuries; Pressure Ulcer
• Other Study ID Numbers: CT1601ACT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No