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

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.

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.

Study Overview

• Status: Completed
• Conditions: Burns; Wound Healing
• Intervention / Treatment: Device: Mepitel Ag

Detailed Description

see Brief summary

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85008
      • Arizona Burn Center
  • Florida
    • Orlando, Florida, United States, 32806
      • Orlando Regional Medical Center
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Wishard
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73116
      • Paul Silverstein, MD
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19134
      • S:t Christopher's Hospital for Children
  • Washington
    • Seattle, Washington, United States, 98104
      • Harborview Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Mepitel Ag; Mepitel Ag is an antimicrobial, meshed, non-adherent wound contact layer allowing passage of exudate and providing fixation and protection of tissues.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Subjects Healed at Day 14.	> = 95 % epitheliazation	Healing will be assessed after 14 days.
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.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent of Study Burn Healed.	Percent of study burn healed measured by PictZar photo analysis of tissue types.	At day 21

Collaborators and Investigators

• Sponsor: Molnlycke Health Care AB
• Investigators: Principal Investigator: Paul Silverstein, MD, INTEGRIS Baptist Medical Center, Inc. Paul Silverstein Burn Center

Study record dates

Study Major Dates

• Study Start: August 1, 2012
• Primary Completion (ACTUAL): August 1, 2013
• Study Completion (ACTUAL): August 1, 2013

Study Registration Dates

• First Submitted: June 26, 2012
• First Submitted That Met QC Criteria: July 5, 2012
• First Posted (ESTIMATE): July 10, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): October 7, 2014
• Last Update Submitted That Met QC Criteria: September 29, 2014
• Last Verified: December 1, 2013

More Information

Terms related to this study

• Keywords: Silver dressing; Partial-thickness second degree burns; Mepitel Ag
• Additional Relevant MeSH Terms: Wounds and Injuries; Burns
• Other Study ID Numbers: MpT Ag 01