Mepilex Transfer Ag
DeviceA soft silicone wound contact layer.
NCT Number: NCT01734317
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Florida Gulf-to-bay Anesthesiology, Tampa, Florida, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
A soft silicone wound contact layer.
Time frame: 14 days and 21 days
Healing at day 14 pt 21. Healing was defined as ≥95% epithelialisation. The PictZar program will be used to analyze burn wound healing by tissue type. ("The PictZar equipment for this analysis will be located at MHC HQ, however, the analysis will be performed by a clinician not affiliated with MHC.") Each subject was followed/assessed one time per week for a maximum of 3 weeks or until the burn was healed if that occured earlier.
Time frame: After 0/14/21 days treatment
Pain will be measured by using the VAS scale, by placing a vertical mark across the 100 mm long horizontal line, from No pain to the left to Most intense pain imaginable to the right.
Baseline (Visit 1) Pain will be measured before burn assessment Visit 2-4, Pain will be measured (Pain BEFORE dressing removal, DURING dressing removal, AFTER dressing removal, 30 min after removal
Molnlycke Health Care AB
Industry
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.
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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