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

Burn Injury Clinical Trial

— 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02210208
• Other study ID #: MpTAg03
• Status: Completed
• Phase: N/A
• First received: August 5, 2014
• Last updated: December 12, 2017
• Start date: September 2014
• Est. completion date: June 15, 2016

Study information

• Verified date: December 2017
• Source: Molnlycke Health Care AB
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: June 15, 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Months to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Burn Injury
• Burns
• Skin Graft

Intervention

Device:
• Mepitel® Ag
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.
• Mepilex® Transfer Ag
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.

Locations

Country	Name	City	State
United States	Long Island Plastic Surgical Group	New York	New York
United States	The University of South Florida Board of Trustees	Orlando	Florida
United States	St. Chrisopher's Hospital for Children	Philadelphia	Pennsylvania
United States	The Arizona Burn Center	Phoenix	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Molnlycke Health Care AB

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	14 days
Primary	Part B	Part B: The healing percentage of donor sites (defined as greater than 95% epithelialization, verified by quantitative photographic analysis).	14 days with 2 visits
Secondary	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.	14 days with 2 visits
Secondary	Part B Secondary Outcome.	Ability of Mepilex® Transfer Ag to adhere to donor site without slippage.	14 days with 2 visits