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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Molnlycke Health Care AB
ClinicalTrials.gov Identifier:
NCT01636362
First received: June 26, 2012
Last updated: December 10, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention
Burns
Wound Healing
Device: Mepitel Ag

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by Molnlycke Health Care AB:

Primary Outcome Measures:
  • Proportion of subjects healed at day 14. [ Time Frame: Healing will be assessed after 14 days. ] [ Designated as safety issue: No ]
  • Proportion of subjects healed at day 21. [ Time Frame: Healing will be assessed after 21 days. ] [ Designated as safety issue: No ]
    The proportion of subjects healed will be assessed at day 14. Wounds not healed at day 14 will be assessed again at day 21.


Secondary Outcome Measures:
  • Percent of burn healed. [ Time Frame: At day 21 ] [ Designated as safety issue: No ]
    Percent of burn healed measured by PictZar photo analysis of tissue types.


Enrollment: 45
Study Start Date: August 2012
Study Completion Date: August 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   2 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01636362

Locations
United States, Arizona
Arizona Burn Center
Phoenix, Arizona, United States, 85008
United States, Florida
Orlando Regional Medical Center
Orlando, Florida, United States, 32806
United States, Indiana
Wishard
Indianapolis, Indiana, United States, 46202
United States, Oklahoma
Paul Silverstein, MD
Oklahoma City, Oklahoma, United States, 73116
United States, Pennsylvania
S:t Christopher's Hospital for Children
Philadelphia, Pennsylvania, United States, 19134
United States, Washington
Harborview Medical Center
Seattle, Washington, United States, 98104
Sponsors and Collaborators
Molnlycke Health Care AB
Investigators
Principal Investigator: Paul Silverstein, MD INTEGRIS Baptist Medical Center, Inc. Paul Silverstein Burn Center
  More Information

No publications provided

Responsible Party: Molnlycke Health Care AB
ClinicalTrials.gov Identifier: NCT01636362     History of Changes
Other Study ID Numbers: MpT Ag 01
Study First Received: June 26, 2012
Last Updated: December 10, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Molnlycke Health Care AB:
Partial-thickness second degree burns
Mepitel Ag
Silver dressing

Additional relevant MeSH terms:
Burns
Wounds and Injuries

ClinicalTrials.gov processed this record on April 17, 2014