An Open Single-centre Investigation Evaluating Efficacy in Second Degree Partial Thickness Burns Using a Silicone Contact Layer Containing Silver.
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|ClinicalTrials.gov Identifier: NCT01734317|
Recruitment Status : Completed
First Posted : November 27, 2012
Results First Posted : March 5, 2014
Last Update Posted : March 2, 2016
|Condition or disease||Intervention/treatment||Phase|
|Wound Healing.||Device: Mepilex Transfer Ag||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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.|
|Study Start Date :||October 2012|
|Actual Primary Completion Date :||February 2013|
|Actual Study Completion Date :||February 2013|
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.
- Efficacy [ Time Frame: 14 days ]Healing at day 14. Healing was defined as ≥95% epithelialisation.
- Pain [ Time Frame: After 14/21 days treatment ]Pain before, during and after dressing removal will be meausered.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01734317
|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|