A Clinical Investigation to Evaluate Efficacy of Mepitel Ag in Partial Thickness Second Degree Burns - Full Text View

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:

MedlinePlus related topics: Burns

U.S. FDA Resources

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.

Estimated Enrollment:	60
Study Start Date:	August 2012
Estimated Study Completion Date:	March 2013
Estimated Primary Completion Date:	February 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

Contacts

Contact: Joan Wilson, RN

706.504.8997

joan.wilson@molnlycke.com

Locations

United States, Arizona
Arizona Burn Center	Recruiting
Phoenix, Arizona, United States, 85008
Contact: Karen Richey, RN, BSN 602-344-5125
Principal Investigator: Kevin N Foster, MD
United States, Florida
Orlando Regional Medical Center	Recruiting
Orlando, Florida, United States, 32806
Contact: Karen Safcsak, RN 407-619-0311 karen.safczak@orlandohealth.com
Principal Investigator: Howard Smith, MD
United States, Indiana
Wishard	Recruiting
Indianapolis, Indiana, United States, 46202
Contact: David Roggy, RN
Principal Investigator: Rajiv Sood, MD
United States, Oklahoma
Paul Silverstein, MD	Recruiting
Oklahoma City, Oklahoma, United States, 73116
Principal Investigator: Paul Silverstein, MD
United States, Pennsylvania
S:t Christopher's Hospital for Children	Recruiting
Philadelphia, Pennsylvania, United States, 19134
Contact: Theresa M Carducci, RN, MSN 215-427-7911
Principal Investigator: Paul Glat, MD
United States, Washington
Harborview Medical Center	Recruiting
Seattle, Washington, United States, 98104
Contact: Shari Honari, RN, BSN 206-744-3587
Principal Investigator: Nicole Gibran, MD

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:	February 22, 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 May 19, 2013