Wounds and InjuriesNCT02807584
Treatment of Wounds With a New Adhesive Foam Dressing
A study testing ELECT in people with Wounds and Injuries and Burns, run by Smith & Nephew, Inc. at 1 site in South Africa.
Trial summary
This study will look at whether ELECT, a new adhesive foam dressing, can offer an alternative to traditional wound care methods. Patients will be treated with ELECT for 14 days. Data relating to wound healing, the performance of the dressing and the opinion of the doctor will be collected. Read more about this study
- Who is it for?
- Ages 1 year and older
- Conditions the study is for
- Wounds and Injuries, Burns
- What is being tested?
- ELECT
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteSouth Africa
- Study dates
- Mar 2016to Jul 2016
- 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 1 year and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Participants must be ≥1 years old
- Males and females (females must not be pregnant and must use contraception if of child bearing potential)
- Participant must have a partial thickness burn, acute or chronic wound that would benefit from the application of an advanced wound dressing to help facilitate moist wound healing
- Presence of a suitable wound which can be treated with the available sizes of the ELECT Adhesive Foam Dressing (7.5cm x 7.5cm, 12.5cm x 12.5cm, 15cm x 15cm and 17.5cm x 17.5cm)
- Participant is under the direct observation of the investigator for the duration of the study (i.e the participant's wound must not be treated by another clinician throughout the duration of the study).
- The participant or the participant's legal representative is able to understand and is willing to consent to the study.
Who cannot join
- Participants with a known history of poor compliance with treatment (including if the participant has a known , diagnosed emotional or neurological condition such as mental disorders/illnesses, mental retardation, drug or alcohol abuse, that would pre-empt their ability to understand and consent)
- Participants who are unable to understand the aims and objectives of the study.
- Participant is a prisoner.
- Participants with a known sensitivity to any of the constituents of the evaluation products, including polyester, polyurethane, and acrylic adhesive
- Participants with facial wounds as the reference wound
- Participants with confirmed or suspected clinically infected reference wounds (unless wounds are being treated per standard protocol for wound infection)
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- Participant is likely to undergo foreseeable definitive surgery within 2 weeks from screening
- Participants where a reference wound cannot be treated in isolation from other wounds
- Participants who have participated in this evaluation previously and closed/100% healed, or have been withdrawn from the study, or any previous studies
- Participant who are employees of Smith \& Nephew group companies
Trial locations and contacts
1 site in 1 country.
South Africa1 site
Inkosi Albert Luthuli Central Hospital (IALCH)
Durban, 4058
About this study
Official title: A Prospective, Open Study to Evaluate the Clinical Performance of a New Adhesive Foam Dressing in the Treatment of Partial Thickness Burns, Acute and Chronic Wounds.
This study will look at whether ELECT, a new adhesive foam dressing, can offer an alternative to traditional wound care methods.
Patients will be treated with ELECT for 14 days. Data relating to wound healing, the performance of the dressing and the opinion of the doctor will be collected.
The hypothesis of this study is that the ELECT foam adhesive dressing is 'fit for purpose' and will be effective at treating a variety of wounds.
- Conditions
- Wounds and Injuries, Burns
- Being tested
- ELECT
- Keywords
- Wound, burns, acute, chronic, foam, adhesive, dressing
- Medical subject headings
- Wounds and Injuries, Burns, Bronchiolitis Obliterans Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ELECTDevice
| Study group | Role | What they receive |
|---|---|---|
| ELECT | Experimental | Adhesive Foam Dressing Receives: Device: ELECT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wound progression, (percentage change in area) using a wound imaging measurement and wound documentation system
using a wound imaging, measurement and wound documentation system
Measured: 14 days
Secondary outcomes (14)
Percentage change in wound depth
Measured: 14 days
Percentage change in wound volume
Measured: 14 days
Duration of dressing wear
Measured: 14 days
The proportion of wounds that have 100% healed or closed by secondary intention.
Measured: 14 days
Assessment of exudate type and amount
Assessment using a modified Bates-Jensen Would Assessment Tool1 and T.I.M.E.2,3)
Measured: 14 days
Assessment of Condition of the peri-wound skin
Assessment using a modified Bates-Jensen Would Assessment Tool1 and T.I.M.E.2,3)
Measured: 14 days
Assessment of the amount of tissue and skin colour
Assessment using a modified Bates-Jensen Would Assessment Tool1 and T.I.M.E.2,3)
Measured: 14 days
Assessment of infection/clinical signs of infection
Assessment using Normal Clinical practice
Measured: 14 days
Pain on application and removal of dressing (using a Visual Analogue Scale (VAS) or FLACC scale)
Measured: 14 days
Reason for dressing change
Measured: 14 days
Ease of application and removal of the ELECT dressing using the visual analogue scale
Measured: 14 days
Overall clinician acceptability with the new dressing
Measured using a questionnaire
Measured: 14 days
Clinician acceptability with dressing performance parameters
Measured using a questionnaire
Measured: 14 days
Safety in use - all adverse events that occur during the study will be recorded
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2016 (estimated)
- Study startMar 2016
- Primary completionJul 2016
- Study completionJul 2016
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
- Herbert B Slade, MD, Study chair, Smith & Nephew, Inc.Jaime E Dickerson, PhD, Study director, Smith & Nephew, Inc.Alessandro Andreone, MD, Principal investigator, Inkosi Albert Luthuli Central Hospital (IALCH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02807584
- Sponsor's protocol ID
- CE053ELE
- Status last verified
- Feb 2018
- First submitted
- 14 Jun 2016
- Last updated
- 19 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Open Study to Evaluate the Clinical Performance of a New Adhesive Foam Dressing in the Treatment of Partial Thickness Burns, Acute and Chronic Wounds.
- ClinicalTrials.gov ID
- NCT02807584
- Acronym / sponsor ID
- CE053ELE
- Conditions
- Wounds and Injuries, Burns
- Keywords
- Wound, burns, acute, chronic, foam, adhesive, dressing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Smith & Nephew, Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2016
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 21 Jun 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.
This study will look at whether ELECT, a new adhesive foam dressing, can offer an alternative to traditional wound care methods.
Patients will be treated with ELECT for 14 days. Data relating to wound healing, the performance of the dressing and the opinion of the doctor will be collected.
The hypothesis of this study is that the ELECT foam adhesive dressing is 'fit for purpose' and will be effective at treating a variety of wounds.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ELECT | Experimental | Device: ELECTAdhesive Foam Dressing |
Who may qualify
- Ages
- 1 year and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Participants must be ≥1 years old
- Males and females (females must not be pregnant and must use contraception if of child bearing potential)
- Participant must have a partial thickness burn, acute or chronic wound that would benefit from the application of an advanced wound dressing to help facilitate moist wound healing
- Presence of a suitable wound which can be treated with the available sizes of the ELECT Adhesive Foam Dressing (7.5cm x 7.5cm, 12.5cm x 12.5cm, 15cm x 15cm and 17.5cm x 17.5cm)
- Participant is under the direct observation of the investigator for the duration of the study (i.e the participant's wound must not be treated by another clinician throughout the duration of the study).
Key exclusion criteria (10 listed)
- Participants with a known history of poor compliance with treatment (including if the participant has a known , diagnosed emotional or neurological condition such as mental disorders/illnesses, mental retardation, drug or alcohol abuse, that would pre-empt their ability to understand and consent)
- Participants who are unable to understand the aims and objectives of the study.
- Participant is a prisoner.
- Participants with a known sensitivity to any of the constituents of the evaluation products, including polyester, polyurethane, and acrylic adhesive
- Participants with facial wounds as 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 |
|---|---|---|
| ELECT | Device | ELECT |
Primary outcome
Wound progression, (percentage change in area) using a wound imaging measurement and wound documentation system
Time frame: 14 days
using a wound imaging, measurement and wound documentation system
14 secondary outcomes
Percentage change in wound depth
Time frame: 14 days
Percentage change in wound volume
Time frame: 14 days
Duration of dressing wear
Time frame: 14 days
The proportion of wounds that have 100% healed or closed by secondary intention.
Time frame: 14 days
Assessment of exudate type and amount
Time frame: 14 days
Assessment of Condition of the peri-wound skin
Time frame: 14 days
Assessment of the amount of tissue and skin colour
Time frame: 14 days
Assessment of infection/clinical signs of infection
Time frame: 14 days
Pain on application and removal of dressing (using a Visual Analogue Scale (VAS) or FLACC scale)
Time frame: 14 days
Reason for dressing change
Time frame: 14 days
Ease of application and removal of the ELECT dressing using the visual analogue scale
Time frame: 14 days
Overall clinician acceptability with the new dressing
Time frame: 14 days
Clinician acceptability with dressing performance parameters
Time frame: 14 days
Safety in use - all adverse events that occur during the study will be recorded
Time frame: 14 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 19 Feb 2018.
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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.
Herbert B Slade, MD study chair
Smith & Nephew, Inc.
Jaime E Dickerson, PhD study director
Smith & Nephew, Inc.
Alessandro Andreone, MD principal investigator
Inkosi Albert Luthuli Central Hospital (IALCH)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ELECT in people with Wounds and Injuries and Burns, run by Smith & Nephew, Inc. at 1 site in South Africa.
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 6 inclusion and 10 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 19 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Africa. 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?
Wound progression, (percentage change in area) using a wound imaging measurement and wound documentation system (time frame: 14 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 19 Feb 2018.