Clinical trial NCT01636362: A Clinical Investigation to Evaluate Efficacy of Mepitel Ag in Partial Thickness Second Degree Burns
Official title: An Open, Non Controlled, Multi-centre, Clinical Investigation to Evaluate Efficacy in Partial Thickness (Superficial, Deep and Mixed) Second Degree Burns When Using a Soft Silicone, Silver Containing, Wound Contact Layer, Mepitel Ag.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Burns
Wound Healing
Keywords: Partial-thickness second degree burns
Mepitel Ag
Silver dressing
Lead sponsor: Molnlycke Health Care AB
Sponsor class: INDUSTRY
First posted: 2012-07-10
Enrollment: 45
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Approximately 55-65 subjects from 3-6 sites suffering from a burn injury covering 1-25% Total Body Surface Area (TBSA) will be evaluated providing they fulfill all inclusion and none of the exclusion criteria and have given a signed and dated informed consent. Study site will be from 1-15%. Each subject will be followed once a week for a maximum of 3 weeks or until the burn is healed if that occurs earlier. All dressing changes will be performed at the clinic and gauze rolls will be used as secondary dressing. All dressing changes will be registered in a dressing log. All subjects will be consecutively allocated to a subject code.

Detailed description: see Brief summary

Eligibility criteria: Inclusion Criteria:

* Subject with a partial-thickness (superficial, deep or mixed) second degree burn from 1-25% TBSA
* Study site is from 1-15% BSA
* Study site is a single, isolated burn area
* From 2 years and above
* Thermal burn injury
* Signed Informed Consent/Assent Form
* Subjects who are younger than the legal consenting age must in addition to their own Assent form have a signature from a legally authorized representative.

Exclusion Criteria:

* Completely non-exuding or dry wound bed at study site
* Full thickness \>5%
* Burn greater than 24 hrs old
* Burns to face or neck
* Suspicion of infection of study burn
* Use of chemical/enzymatic and biological debridement within 7 days of investigation start
* Chronic steroid use, hx of skin malignancy or chronic papulosquamous disease (e.g. eczema, Pemphigus) and hx of Steven Johnson or TENS disease
* Subject with lung injury or subject being on a ventilator
* Subject with dermatologic skin disorders or necrotizing processes
* Subject with insulin dependent diabetes mellitus
* Electrical, chemical etiology
* Diagnosed underlying disease(s) (e.g. HIV/AIDS, cancer and severe anaemia), judged by the investigator to be a potential interference in the treatment
* Non-compliant subject
* Subject previously included in this investigation
* Subject included in other ongoing clinical investigation at present or during the past 30 days.

Primary outcomes:
measure: Number of Subjects Healed at Day 14.
timeFrame: Healing will be assessed after 14 days.
measure: Proportion of Subjects Healed at Day 21.
timeFrame: Healing will be assessed after 21 days.
Secondary outcomes:
measure: Percent of Study Burn Healed.
timeFrame: At day 21
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Arizona Burn Center
state: Arizona
city: Orlando
country: United States
facility: Orlando Regional Medical Center
state: Florida
city: Indianapolis
country: United States
facility: Wishard
state: Indiana
city: Oklahoma City
country: United States
facility: Paul Silverstein, MD
state: Oklahoma
city: Philadelphia
country: United States
facility: S:t Christopher's Hospital for Children
state: Pennsylvania
city: Seattle
country: United States
facility: Harborview Medical Center
state: Washington
Study officials:
affiliation: INTEGRIS Baptist Medical Center, Inc. Paul Silverstein Burn Center
name: Paul Silverstein, MD
role: PRINCIPAL_INVESTIGATOR
References: