An Open Single-centre Investigation Evaluating Efficacy in Second Degree Partial Thickness Burns Using a Silicone Contact Layer Containing Silver.

Completed · Not applicable

Conditions studied: Wound Healing

In brief

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.

Key facts

Study ID

NCT01734317

Run by

Molnlycke Health Care AB

People needed

10

Starts

2012-10-01

Expected to finish

2013-02-01

Last updated by the study team

2020-04-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Florida Gulf-to-bay Anesthesiology — Tampa, Florida, United States
• Long Island Plastic Surgical Group, P.C — Garden City, New York, United States

Full record on ClinicalTrials.gov

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