An Open Single-centre Investigation Evaluating Efficacy in Second Degree Partial Thickness Burns … (NCT01734317) | Clinical Trial Compass
CompletedNot Applicable
An Open Single-centre Investigation Evaluating Efficacy in Second Degree Partial Thickness Burns Using a Silicone Contact Layer Containing Silver.
United States10 participantsStarted 2012-10
Plain-language summary
Approximately 10 subjects from one clinic having sustained a burn injury covering 1-25% or the Total Body surface Area (TBSA)and assessed as superficial partial-thickness or superficial deep-partial-thickness. The subject will be assessed once a week for a maximum of 3 weeks or until the burn is healed if that occurs earlier. . The dressing Mepilex Transfer Ag will be used as wound contact layer and gauze rolls and compression as second dressing.
Who can participate
Age range
18 Years
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:
* Subject with a second degree (superficial, deep or mixed) partial thickness burn from 1-25% TBSA.
* One single, isolated burn area selected for study site Study site area should be between 1-15% BSA
* Male or female
* From 18 years and above
* Either in- or out-patient
* Thermal burn injury
* Signed Informed Consent/Assent Form
Exclusion Criteria:
* Electrical, chemical burn etiology
* If any full thickness areas are present, these should not be \> 5 %
* Burn greater than 36 hrs old
* Burns to face
* Use of chemical/enzymatic and biological debridement within 7 days of investigation start
* Presence of inflammation or infection in burn wounds
* Use of topical antibiotics, antiseptics, or antimicrobials in conjunction with study product.
* Subjects with lung injury or Subject being on a ventilator
* Subjects with dermatologic skin disorders or necrotizing processes
* Subjects with insulin dependent diabetes mellitus judged by the investigator to be a potential interference in the treatment
* Diagnosed underlying disease(s) (e.g HIV/AIDS, cancer and severe anaemia) judged by the investigator to be a potential interference in the treatment
* Subject not expected to follow the investigation procedures
* Subjects previously included in this investigation
* Subjects included in other ongoing clinical investigation at present or during the past 30 days
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.