An Open Single-centre Investigation Evaluating Efficacy in Second Degree Partial Thickness Burns Using a Silicone Contact Layer Containing Silver.
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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||An Open, Non Controled, Single-centre, Clinical Investigation to Evaluate Efficacy in Second Degree (Superficial, Deep or Mixed) Partial Thickness Burns When Using a Soft Silicone Wound Contact Ayer Containing Silver.|
- Efficacy [ Time Frame: 14 days ] [ Designated as safety issue: No ]Proportion of subjects healed at day 14. Healing will be defined as ≥95% epithelialisation.
- Efficacy [ Time Frame: 21 days ] [ Designated as safety issue: No ]Subjects not healed after 14 days will be assessed at day 21.
- Pain [ Time Frame: After 14/21 days treatment ] [ Designated as safety issue: No ]Pain before, during and after dressing removal will be meausered.
|Study Start Date:||October 2012|
|Study Completion Date:||February 2013|
|Primary Completion Date:||February 2013 (Final data collection date for primary outcome measure)|
Mepilex Transfer Ag is a soft silicone wound contact layer that absorbs and transfers exudate, maintains a moist wound healing environment and has antimicrobial properties.
Device: Mepilex Transfer Ag
A soft silicone wound contact layer.
Approximately 10 subjects from one site will be evaluated provided they fulfill the inclusion criteria and none of the exclusion criteria and gives a signed and dated consent.
Subjects may have sustained a burn injury covering 1-25% of the Total Body Surface Area (TBSA)and assessed as superficial partial-thickness or superficial deep-partial thickness in dept. Each subject will be followed one time per week for a maximum of 3 weeks or until the burn is healed if that occurs earlier. Healing is defined as ≥95% epithelialisation. Percent (%) healed epithelialization will be measured by photo analysing using the PictZar program. Dressing changes will be performed at each visit and in between if deemed necessary by the investigator.Gauze rolls and compression will be used as secondary dressing.All dressing changes will be registered in a log. Pain before, during and after removal will be assessed.
|United States, Florida|
|Florida Gulf-to-bay Anesthesiology|
|Tampa, Florida, United States, 33606|
|United States, New York|
|Long Island Plastic Surgical Group, P.C|
|Garden City, New York, United States, 11530|
|Principal Investigator:||Hans Schweiger, MD||Florida Gulf-toBay Anesthesiology, Tampa Bay Circle|