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

Primary Purpose

Burns, Wound Healing

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mepitel Ag
Sponsored by
Molnlycke Health Care AB
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Burns focused on measuring Partial-thickness second degree burns, Mepitel Ag, Silver dressing

Eligibility Criteria

2 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Arizona Burn Center
  • Orlando Regional Medical Center
  • Wishard
  • Paul Silverstein, MD
  • S:t Christopher's Hospital for Children
  • Harborview Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Mepitel Ag

Arm Description

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

Outcomes

Primary Outcome Measures

Number of Subjects Healed at Day 14.
> = 95 % epitheliazation
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.

Secondary Outcome Measures

Percent of Study Burn Healed.
Percent of study burn healed measured by PictZar photo analysis of tissue types.

Full Information

First Posted
June 26, 2012
Last Updated
September 29, 2014
Sponsor
Molnlycke Health Care AB
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1. Study Identification

Unique Protocol Identification Number
NCT01636362
Brief Title
A Clinical Investigation to Evaluate Efficacy of Mepitel Ag in Partial Thickness Second Degree Burns
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.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
August 2012 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
August 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Molnlycke Health Care AB

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Burns, Wound Healing
Keywords
Partial-thickness second degree burns, Mepitel Ag, Silver dressing

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mepitel Ag
Arm Type
Experimental
Arm Description
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
Intervention Name(s)
Mepitel Ag
Intervention Description
Mepitel Ag is an antimicrobial, meshed, non-adherent wound contact layer allowing passage of exudate and providing fixation and protection of tissues.
Primary Outcome Measure Information:
Title
Number of Subjects Healed at Day 14.
Description
> = 95 % epitheliazation
Time Frame
Healing will be assessed after 14 days.
Title
Proportion of Subjects Healed at Day 21.
Description
The proportion of subjects healed will be assessed at day 14. Wounds not healed at day 14 will be assessed again at day 21.
Time Frame
Healing will be assessed after 21 days.
Secondary Outcome Measure Information:
Title
Percent of Study Burn Healed.
Description
Percent of study burn healed measured by PictZar photo analysis of tissue types.
Time Frame
At day 21

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul Silverstein, MD
Organizational Affiliation
INTEGRIS Baptist Medical Center, Inc. Paul Silverstein Burn Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Arizona Burn Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85008
Country
United States
Facility Name
Orlando Regional Medical Center
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Wishard
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Paul Silverstein, MD
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73116
Country
United States
Facility Name
S:t Christopher's Hospital for Children
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19134
Country
United States
Facility Name
Harborview Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States

12. IPD Sharing Statement

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

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