Treatment of Wounds With a New Adhesive Foam Dressing (NCT02807584) | Clinical Trial Compass
CompletedNot Applicable
Treatment of Wounds With a New Adhesive Foam Dressing
South Africa25 participantsStarted 2016-03
Plain-language 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.
Who can participate
Age range
1 Year
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Wound progression, (percentage change in area) using a wound imaging measurement and wound documentation system
. 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