Clinical trial NCT01734317: An Open Single-centre Investigation Evaluating Efficacy in Second Degree Partial Thickness Burns Using a Silicone Contact Layer Containing Silver.
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Wound Healing
Lead sponsor: Molnlycke Health Care AB
Sponsor class: INDUSTRY
First posted: 2012-11-27
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With Wound Healing
timeFrame: 14 days and 21 days
Secondary outcomes:
measure: 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
timeFrame: After 0/14/21 days treatment
Other outcomes:
Locations:
city: Tampa
country: United States
facility: Florida Gulf-to-bay Anesthesiology
state: Florida
city: Garden City
country: United States
facility: Long Island Plastic Surgical Group, P.C
state: New York
Study officials:
affiliation: Florida Gulf-toBay Anesthesiology, Tampa Bay Circle
name: Hans Schweiger, MD
role: PRINCIPAL_INVESTIGATOR
References: