Back to resultsACTICOAT™ for the Treatment of Burns and Chronic Wounds
Primary Purpose
Wounds and Injuries, Burns, Pressure Ulcer
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
ACTICOAT
Sponsored by
About this trial
This is an interventional treatment trial for Wounds and Injuries focused on measuring Wound, Pressure Ulcer, Diabetic Foot Ulcer, Venous Leg Ulcer, Burn, Quality of Life
Eligibility Criteria
INCLUSION CRITERIA
- Must provide informed consent to participate in the study.
- Eighteen (18) years of age or older.
- Males and females.
- Able to follow instructions and be deemed capable of completing the EQ-5D 5L Questionnaire appropriately.
- Willing and able to make all required study visits, and provide a daytime telephone number on which they can be contacted directly.
Presenting with either a chronic wound or burn which is deemed suitable for treatment with ACTICOAT and meets either of the following requirements:
- 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.
- 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
- Contraindications or hypersensitivity to the use of the test article, ancillary products or their components (e.g., known sensitivity to silver).
- Participation in the treatment period of another clinical trial within thirty (30) days of Visit 1.
- Treatment with any other silver dressing (i.e. non ACTICOAT dressing) within seven (7) days of Visit 1.
- Patients with skin features which in the opinion of the Investigator, will interfere with the study assessments.
- Patients requiring concomitant use of NPWT on the reference wound.
- Patients who have participated previously in this clinical trial and who have healed or been withdrawn.
- Patients with a history of poor compliance with medical treatment.
- Patients who, in the opinion of the Investigator, are experiencing burn shock.
- Patients with any other medical or physical condition that, in the opinion of the Investigator, would preclude safe subject participation in the study.
Sites / Locations
- Northumbria Healthcare NHS Foundation Trust
- Leeds Wounds Research Unit
- The Mid Yorkshire Hospitals NHS Trust
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
ACTICOAT
Arm Description
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.
Outcomes
Primary Outcome Measures
Change in EQ-5D 5L mean single index utility scores (EuroQol Research Foundation 2015).
Secondary Outcome Measures
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
Wound length
Wound width
Wound depth
Reference wound healed (% re-epithelialized)
Amount of healthy tissue (% tissue types)
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
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
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)
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).
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
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
Serious adverse events
Record of absolute number of serious adverse events observed in the study, together with associated details
Non-serious adverse events
Record of the absolute number of non-serious adverse events observed in the study, together with associated details
Device deficiencies
Record of the absolute number of device deficiencies observed in the study, together with associated details
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02852148
Brief Title
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
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
November 2016 (Actual)
Primary Completion Date
November 28, 2017 (Actual)
Study Completion Date
December 13, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Smith & Nephew, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wounds and Injuries, Burns, Pressure Ulcer, Foot Ulcer
Keywords
Wound, Pressure Ulcer, Diabetic Foot Ulcer, Venous Leg Ulcer, Burn, Quality of Life
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ACTICOAT
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
ACTICOAT
Intervention Description
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 Measure Information:
Title
Change in EQ-5D 5L mean single index utility scores (EuroQol Research Foundation 2015).
Time Frame
21 days
Secondary Outcome Measure Information:
Title
Clinical signs and symptoms of infection
Description
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
Title
Wound length
Time Frame
21 days
Title
Wound width
Time Frame
21 days
Title
Wound depth
Time Frame
21 days
Title
Reference wound healed (% re-epithelialized)
Time Frame
21 days
Title
Amount of healthy tissue (% tissue types)
Time Frame
21 days
Title
Condition of surrounding skin
Description
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
Title
Extent of tissue staining
Description
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
Title
Pain on dressing application
Description
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
Title
Pain on dressing removal
Description
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
Title
Ease of dressing application
Description
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
Title
Ease of dressing removal
Description
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
Title
Serious adverse events
Description
Record of absolute number of serious adverse events observed in the study, together with associated details
Time Frame
21 days
Title
Non-serious adverse events
Description
Record of the absolute number of non-serious adverse events observed in the study, together with associated details
Time Frame
21 days
Title
Device deficiencies
Description
Record of the absolute number of device deficiencies observed in the study, together with associated details
Time Frame
21 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
INCLUSION CRITERIA
Must provide informed consent to participate in the study.
Eighteen (18) years of age or older.
Males and females.
Able to follow instructions and be deemed capable of completing the EQ-5D 5L Questionnaire appropriately.
Willing and able to make all required study visits, and provide a daytime telephone number on which they can be contacted directly.
Presenting with either a chronic wound or burn which is deemed suitable for treatment with ACTICOAT and meets either of the following requirements:
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.
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
Contraindications or hypersensitivity to the use of the test article, ancillary products or their components (e.g., known sensitivity to silver).
Participation in the treatment period of another clinical trial within thirty (30) days of Visit 1.
Treatment with any other silver dressing (i.e. non ACTICOAT dressing) within seven (7) days of Visit 1.
Patients with skin features which in the opinion of the Investigator, will interfere with the study assessments.
Patients requiring concomitant use of NPWT on the reference wound.
Patients who have participated previously in this clinical trial and who have healed or been withdrawn.
Patients with a history of poor compliance with medical treatment.
Patients who, in the opinion of the Investigator, are experiencing burn shock.
Patients with any other medical or physical condition that, in the opinion of the Investigator, would preclude safe subject participation in the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Beate Hanson, VP, PhD
Organizational Affiliation
Smith & Nephew, Inc.
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Lyn Wilson, MA
Organizational Affiliation
Pinderfield Hospitals
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northumbria Healthcare NHS Foundation Trust
City
Ashington
ZIP/Postal Code
NE630HP
Country
United Kingdom
Facility Name
Leeds Wounds Research Unit
City
Leeds
ZIP/Postal Code
LS12 3QE
Country
United Kingdom
Facility Name
The Mid Yorkshire Hospitals NHS Trust
City
Wakefield
ZIP/Postal Code
WF1 4EE
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
ACTICOAT™ for the Treatment of Burns and Chronic Wounds
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