Wounds and InjuriesNCT02852148
ACTICOAT™ for the Treatment of Burns and Chronic Wounds
A study testing ACTICOAT in people with Wounds and Injuries and Burns, run by Smith & Nephew, Inc. at 3 sites in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Wounds and Injuries, Burns, Pressure Ulcer
- What is being tested?
- ACTICOAT
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 3 sitesUnited Kingdom
- Study dates
- Nov 2016to 13 Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
3 sites in 1 country.
United Kingdom3 sites
Northumbria Healthcare NHS Foundation Trust
Ashington, NE630HP
Leeds Wounds Research Unit
Leeds, LS12 3QE
The Mid Yorkshire Hospitals NHS Trust
Wakefield, WF1 4EE
About this study
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.
The aim of the study is to evaluate participant reported quality of life, safety, and overall performance with ACTICOAT in a clinical setting.
Read the 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.
- Conditions
- Wounds and Injuries, Burns, Pressure Ulcer, Foot Ulcer
- Being tested
- ACTICOAT
- Keywords
- Wound, Pressure Ulcer, Diabetic Foot Ulcer, Venous Leg Ulcer, Burn, Quality of Life
- Medical subject headings
- Wounds and Injuries, Burns, Pressure Ulcer, Foot Ulcer, Diabetic Foot, Varicose Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACTICOATDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| ACTICOAT | Experimental | 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. Receives: Device: ACTICOAT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in EQ-5D 5L mean single index utility scores (EuroQol Research Foundation 2015).
Measured: 21 days
Secondary outcomes (15)
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
Measured: 21 days
Wound length
Measured: 21 days
Wound width
Measured: 21 days
Wound depth
Measured: 21 days
Reference wound healed (% re-epithelialized)
Measured: 21 days
Amount of healthy tissue (% tissue types)
Measured: 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
Measured: 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
Measured: 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)
Measured: 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).
Measured: 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
Measured: 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
Measured: 21 days
Serious adverse events
Record of absolute number of serious adverse events observed in the study, together with associated details
Measured: 21 days
Non-serious adverse events
Record of the absolute number of non-serious adverse events observed in the study, together with associated details
Measured: 21 days
Device deficiencies
Record of the absolute number of device deficiencies observed in the study, together with associated details
Measured: 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2016 (estimated)
- Study startNov 2016
- Primary completion28 Nov 2017
- Study completion13 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wounds and InjuriesStudies of the same condition, open and under way.
- More trials run by Smith & Nephew, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Smith & Nephew, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Beate Hanson, VP, PhD, Study chair, Smith & Nephew, Inc.Lyn Wilson, MA, Principal investigator, Pinderfield Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02852148
- Sponsor's protocol ID
- CT1601ACT
- Status last verified
- Apr 2019
- First submitted
- 24 Jun 2016
- Last updated
- 4 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT02852148
- Acronym / sponsor ID
- CT1601ACT
- Conditions
- Wounds and Injuries, Burns, Pressure Ulcer, Foot Ulcer
- Keywords
- Wound, Pressure Ulcer, Diabetic Foot Ulcer, Venous Leg Ulcer, Burn, Quality of Life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Smith & Nephew, Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2016 (actual)
- Primary completion
- 28 Nov 2017 (actual)
- Study completion
- 13 Dec 2017 (actual)
- First posted
- 2 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ACTICOAT | Experimental | Device: ACTICOATACTICOAT 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ACTICOATACTICOAT 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 |
Primary outcome
Change in EQ-5D 5L mean single index utility scores (EuroQol Research Foundation 2015).
Time frame: 21 days
15 secondary outcomes
Clinical signs and symptoms of infection
Time frame: 21 days
Wound length
Time frame: 21 days
Wound width
Time frame: 21 days
Wound depth
Time frame: 21 days
Reference wound healed (% re-epithelialized)
Time frame: 21 days
Amount of healthy tissue (% tissue types)
Time frame: 21 days
Condition of surrounding skin
Time frame: 21 days
Extent of tissue staining
Time frame: 21 days
Pain on dressing application
Time frame: 21 days
Pain on dressing removal
Time frame: 21 days
Ease of dressing application
Time frame: 21 days
Ease of dressing removal
Time frame: 21 days
Serious adverse events
Time frame: 21 days
Non-serious adverse events
Time frame: 21 days
Device deficiencies
Time frame: 21 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Beate Hanson, VP, PhD study chair
Smith & Nephew, Inc.
Lyn Wilson, MA principal investigator
Pinderfield Hospitals
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ACTICOAT in people with Wounds and Injuries and Burns, run by Smith & Nephew, Inc. at 3 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in EQ-5D 5L mean single index utility scores (EuroQol Research Foundation 2015). (time frame: 21 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2019.