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A Soft Silicone Wound Contact Layer Containing Silver in the Treatment of Skin Grafts in Surgical Burn Patients. (MpTAg03)

Primary Purpose

Burn Injury, Skin Graft

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

About this trial

This is an interventional treatment trial for Burn Injury

Eligibility Criteria

18 Months - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Part A

Inclusion Criteria

  • Subjects with burn injury resulting in up to 30% TBSA
  • Full thickness area of burn should not be more than 20%
  • Area in need of skin grafting can be 1-15% TBSA
  • Study site area must have healthy, intact peri-wound skin surrounding it to allow for adequate overlap of study product
  • Thermal injuries only
  • Subjects age 18 months to < 65 years.
  • Signed informed consent
  • 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

  • Greater than 30% TBSA
  • Full thickness areas greater than 20% TBSA
  • Full thickness area to be grafted less than 1%
  • Presence of respiratory involvement
  • Subjects on mechanical ventilation
  • Subjects with infected burn wounds
  • Subjects with organ failure
  • Diagnosed underlying disease(s) (e.g. HIV/AIDS, cancer and severe aeaemia) judged by the investigator to be a potential interference in the treatment
  • Subjects treated with systemic glucocorticosteroids, except patients taking occasional doses or doses less than 10mg prednisolone/day or equivalent
  • Known allergy/hypersensitivity to any of the components of the investigation products.
  • Subjects with physical and/or mental conditions that are not expected to comply with the investigation, including patients totally confined to bed
  • Participation in other clinical investigation(s) within 1 month prior to start of the investigation
  • Previous randomized to this investigation

Part B

Inclusion Criteria

-There must be healthy, intact peri-wound skin surrounding the planned donor site to allow for adequate overlap of study product (5 cm)

Exclusion Criteria

  • Investigator do not agree to treat the donor site with Mepilex Transfer Ag
  • The subject do not agree to participate in the donor site part

Sites / Locations

  • The Arizona Burn Center
  • The University of South Florida Board of Trustees
  • Long Island Plastic Surgical Group
  • St. Chrisopher's Hospital for Children

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Mepitel® Ag

Mepilex® Transfer Ag

Arm Description

A dressing device used for surgical burn wounds with skin graft.

Donor site dressing device in the very same patient.

Outcomes

Primary Outcome Measures

Part A: Number of Participants With Healing
Part A: Adequate take of skin graft (defined as at least 95% adherent and healed as assessed by clinical investigator).
Part B
Part B: The healing percentage of donor sites (defined as greater than 95% epithelialization, verified by quantitative photographic analysis).

Secondary Outcome Measures

Part A Secondary Outcome.
Satisfactory fixation of the product over the skin graft was assessed by a series of questions regarding the product assessment of product in place at each visit. Ability to pass exudate to the secondary dressing was demonstrated by a series of questions regarding the exudate at each visit as well as the adherence of the dressing at removal which would show the ability of the dressing to pass the exudate to the secondary dressing rather than creating eschar between the wound and the dressing.
Part B Secondary Outcome.
Ability of Mepilex® Transfer Ag to adhere to donor site without slippage.

Full Information

First Posted
August 5, 2014
Last Updated
December 12, 2017
Sponsor
Molnlycke Health Care AB
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1. Study Identification

Unique Protocol Identification Number
NCT02210208
Brief Title
A Soft Silicone Wound Contact Layer Containing Silver in the Treatment of Skin Grafts in Surgical Burn Patients.
Acronym
MpTAg03
Official Title
An Open, Non-controlled, Multi-centre, Clinical Investigation to Verify Performance and Safety of a Soft Silicone Wound Contact Layer Containing Silver in the Treatment of Skin Grafts in Surgical Burn Patients and the Usefulness of a Marketed Donor Site Dressing.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
September 2014 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
June 15, 2016 (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
Part A The primary objective of Part A will be to verify performance and safety of Mepitel® Ag, a meshed, non- adherent soft silicone wound contact layer containing silver in the treatment of skin grafts in surgical burn patients. Part B The primary objective of Part B will be to examine the usefulness of Mepilex® Transfer Ag as an adequate option for donor site healing.
Detailed Description
This post market clinical follow-up investigation is designed as an open, non-controlled, multi- centre, clinical investigation. A total of approximately 25 subjects from among 4-6 clinical investigative sites will be evaluated providing they fulfill all the inclusion criteria and none of the exclusion criteria. A signed and dated informed consent/assent will be obtained for all subjects. Subjects to be included will present with a thermal burn injury that will require skin grafting and result in a donor site. Overall percent Total Body Surface Area (%TBSA) burned will not exceed 30%. The subjects will be consecutively allocated to a subject code providing they fulfill all inclusion criteria and none of the exclusion criteria and have signed a written consent. The subjects were participating in the study for 14 days postop.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Burn Injury, Skin Graft

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Two Parts (part A and B) with one dressing device for the skin graft placed on a surgical burn wound and another dressing device placed on the donor site.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mepitel® Ag
Arm Type
Experimental
Arm Description
A dressing device used for surgical burn wounds with skin graft.
Arm Title
Mepilex® Transfer Ag
Arm Type
Experimental
Arm Description
Donor site dressing device in the very same patient.
Intervention Type
Device
Intervention Name(s)
Mepitel® Ag
Intervention Description
A soft silicone wound contact layer that allows exudates to pass vertically into a secondary absorbent dressing. The product provides fixation and protection of the tissues and has antimicrobial properties. This silicone net dressing will be used to prevent lifting and adherence of skin grafts to the dressings, as well as to prevent pain, and promote healing.
Intervention Type
Device
Intervention Name(s)
Mepilex® Transfer Ag
Intervention Description
Mepilex® Transfer Ag is a soft silicone wound contact layer that absorbs and transfers exudate, maintains a moist wound healing environment and has antimicrobial properties. Mepilex® Transfer Ag consists of a Safetac® adhesive layer and compressed polyurethane foam containing silver sulphate and activated carbon. Safetac® is a unique adhesive technology that minimizes pain to patients and trauma to wounds and the surrounding skin. It minimizes risk for maceration by sealing the wound margins; ensuring exudate does not spread to the surrounding skin.
Primary Outcome Measure Information:
Title
Part A: Number of Participants With Healing
Description
Part A: Adequate take of skin graft (defined as at least 95% adherent and healed as assessed by clinical investigator).
Time Frame
14 days
Title
Part B
Description
Part B: The healing percentage of donor sites (defined as greater than 95% epithelialization, verified by quantitative photographic analysis).
Time Frame
14 days with 2 visits
Secondary Outcome Measure Information:
Title
Part A Secondary Outcome.
Description
Satisfactory fixation of the product over the skin graft was assessed by a series of questions regarding the product assessment of product in place at each visit. Ability to pass exudate to the secondary dressing was demonstrated by a series of questions regarding the exudate at each visit as well as the adherence of the dressing at removal which would show the ability of the dressing to pass the exudate to the secondary dressing rather than creating eschar between the wound and the dressing.
Time Frame
14 days with 2 visits
Title
Part B Secondary Outcome.
Description
Ability of Mepilex® Transfer Ag to adhere to donor site without slippage.
Time Frame
14 days with 2 visits

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Months
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Part A Inclusion Criteria Subjects with burn injury resulting in up to 30% TBSA Full thickness area of burn should not be more than 20% Area in need of skin grafting can be 1-15% TBSA Study site area must have healthy, intact peri-wound skin surrounding it to allow for adequate overlap of study product Thermal injuries only Subjects age 18 months to < 65 years. Signed informed consent 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 Greater than 30% TBSA Full thickness areas greater than 20% TBSA Full thickness area to be grafted less than 1% Presence of respiratory involvement Subjects on mechanical ventilation Subjects with infected burn wounds Subjects with organ failure Diagnosed underlying disease(s) (e.g. HIV/AIDS, cancer and severe aeaemia) judged by the investigator to be a potential interference in the treatment Subjects treated with systemic glucocorticosteroids, except patients taking occasional doses or doses less than 10mg prednisolone/day or equivalent Known allergy/hypersensitivity to any of the components of the investigation products. Subjects with physical and/or mental conditions that are not expected to comply with the investigation, including patients totally confined to bed Participation in other clinical investigation(s) within 1 month prior to start of the investigation Previous randomized to this investigation Part B Inclusion Criteria -There must be healthy, intact peri-wound skin surrounding the planned donor site to allow for adequate overlap of study product (5 cm) Exclusion Criteria Investigator do not agree to treat the donor site with Mepilex Transfer Ag The subject do not agree to participate in the donor site part
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul Glat, Professor
Organizational Affiliation
Drexel University College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Arizona Burn Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85008
Country
United States
Facility Name
The University of South Florida Board of Trustees
City
Orlando
State/Province
Florida
ZIP/Postal Code
32886-4687
Country
United States
Facility Name
Long Island Plastic Surgical Group
City
New York
State/Province
New York
ZIP/Postal Code
11530
Country
United States
Facility Name
St. Chrisopher's Hospital for Children
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19134
Country
United States

12. IPD Sharing Statement

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A Soft Silicone Wound Contact Layer Containing Silver in the Treatment of Skin Grafts in Surgical Burn Patients.

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