Treatment of Wounds With a New Adhesive Foam Dressing

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Wounds and Injuries, Burns

Intervention / Treatment
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* Device: ELECT


Participation Criteria
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Eligibility Criteria
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INCLUSION CRITERIA 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. EXCLUSION CRITERIA 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) 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

Ages Eligible for Study
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Minimum Age: 1 Year

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ELECT<br>Adhesive Foam Dressing | Device: ELECT<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wound progression, (percentage change in area) using a wound imaging measurement and wound documentation system | using a wound imaging, measurement and wound documentation system | 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage change in wound depth |  | 14 days | 
| Percentage change in wound volume |  | 14 days | 
| Duration of dressing wear |  | 14 days | 
| The proportion of wounds that have 100% healed or closed by secondary intention. |  | 14 days | 
| Assessment of exudate type and amount | Assessment using a modified Bates-Jensen Would Assessment Tool1 and T.I.M.E.2,3) | 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) | 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) | 14 days | 
| Assessment of infection/clinical signs of infection | Assessment using Normal Clinical practice | 14 days | 
| Pain on application and removal of dressing (using a Visual Analogue Scale (VAS) or FLACC scale) |  | 14 days | 
| Reason for dressing change |  | 14 days | 
| Ease of application and removal of the ELECT dressing using the visual analogue scale |  | 14 days | 
| Overall clinician acceptability with the new dressing | Measured using a questionnaire | 14 days | 
| Clinician acceptability with dressing performance parameters | Measured using a questionnaire | 14 days | 
| Safety in use - all adverse events that occur during the study will be recorded |  | 14 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Wound, burns, acute, chronic, foam, adhesive, dressing