A Clinical Investigation to Evaluate Efficacy of Mepitel Ag in Partial Thickness Second Degree Burns

Burns Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01636362
• Other study ID #: MpT Ag 01
• Status: Completed
• Phase: N/A
• First received: June 26, 2012
• Last updated: September 29, 2014
• Start date: August 2012
• Est. completion date: August 2013

Study information

• Verified date: December 2013
• Source: Molnlycke Health Care AB
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Description:

see Brief summary

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Burns
• Wound Healing

Intervention

Device:
• Mepitel Ag
Mepitel Ag is an antimicrobial, meshed, non-adherent wound contact layer allowing passage of exudate and providing fixation and protection of tissues.

Locations

Country	Name	City	State
United States	Wishard	Indianapolis	Indiana
United States	Paul Silverstein, MD	Oklahoma City	Oklahoma
United States	Orlando Regional Medical Center	Orlando	Florida
United States	S:t Christopher's Hospital for Children	Philadelphia	Pennsylvania
United States	Arizona Burn Center	Phoenix	Arizona
United States	Harborview Medical Center	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Molnlycke Health Care AB

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Subjects Healed at Day 14.	> = 95 % epitheliazation	Healing will be assessed after 14 days.	No
Primary	Proportion of Subjects Healed at Day 21.	The proportion of subjects healed will be assessed at day 14. Wounds not healed at day 14 will be assessed again at day 21.	Healing will be assessed after 21 days.	No
Secondary	Percent of Study Burn Healed.	Percent of study burn healed measured by PictZar photo analysis of tissue types.	At day 21	No