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

NCT ID: NCT01636362

Last Updated: 2014-10-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-08-31
• Study Completion Date: 2013-08-31

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

Conditions

Burns; Wound Healing

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Mepitel Ag

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

Group Type: EXPERIMENTAL

Mepitel Ag

Intervention Type: DEVICE

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

Interventions

Mepitel Ag

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

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 2 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Molnlycke Health Care AB

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Paul Silverstein, MD

Role: PRINCIPAL_INVESTIGATOR

INTEGRIS Baptist Medical Center, Inc. Paul Silverstein Burn Center

Locations

Arizona Burn Center

Phoenix, Arizona, United States

Orlando Regional Medical Center

Orlando, Florida, United States

Wishard

Indianapolis, Indiana, United States

Paul Silverstein, MD

Oklahoma City, Oklahoma, United States

S:t Christopher's Hospital for Children

Philadelphia, Pennsylvania, United States

Harborview Medical Center

Seattle, Washington, United States

Countries

United States

Other Identifiers

MpT Ag 01

Identifier Type: -

Identifier Source: org_study_id