NCT02807584CompletedNot Applicable
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
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Smith & Nephew, Inc.
- Enrollment
- 25
- Locations
- 2
- Primary Endpoint
- Wound progression, (percentage change in area) using a wound imaging measurement and wound documentation system
Study Overview
Brief 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.
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
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 1 Year to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
ELECT
Experimental
Adhesive Foam Dressing
Intervention: ELECT (Device)
Outcomes
Primary Outcomes
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
Secondary Outcomes
- Pain on application and removal of dressing (using a Visual Analogue Scale (VAS) or FLACC scale)(14 days)
- Duration of dressing wear(14 days)
- Assessment of exudate type and amount(14 days)
- Percentage change in wound depth(14 days)
- The proportion of wounds that have 100% healed or closed by secondary intention.(14 days)
- Percentage change in wound volume(14 days)
- Assessment of Condition of the peri-wound skin(14 days)
- Assessment of the amount of tissue and skin colour(14 days)
- Reason for dressing change(14 days)
- Ease of application and removal of the ELECT dressing using the visual analogue scale(14 days)
- Clinician acceptability with dressing performance parameters(14 days)
- Assessment of infection/clinical signs of infection(14 days)
- Overall clinician acceptability with the new dressing(14 days)
- Safety in use - all adverse events that occur during the study will be recorded(14 days)
Investigators
Study Sites (2)
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