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

Not Applicable

Completed

Brief 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.

Detailed Description: 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Dressing	Mepilex Transfer Ag	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.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Wound Healing	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.

Secondary Outcome Measures

Name	Time	Method
Baseline (Visit 1) Pain Will be Measured Before Burn Assessment Visit 2-3, Pain Will be Measured (Pain BEFORE Dressing Removal, DURING Dressing Removal, AFTER Dressing Removal, 30 Min After Removal	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

Locations (2): Florida Gulf-to-bay Anesthesiology
🇺🇸
Tampa, Florida, United States
Long Island Plastic Surgical Group, P.C
🇺🇸
Garden City, New York, United States