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 range18 Years
SexALL
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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