Clinical trial NCT02210208: A Soft Silicone Wound Contact Layer Containing Silver in the Treatment of Skin Grafts in Surgical Burn Patients.
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
Overall status: COMPLETED
Phase: NA
Conditions: Burn Injury
Skin Graft
Lead sponsor: Molnlycke Health Care AB
Sponsor class: INDUSTRY
First posted: 2014-08-06
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Part A: Number of Participants With Healing
timeFrame: 14 days
measure: Part B
timeFrame: 14 days with 2 visits
Secondary outcomes:
measure: Part A Secondary Outcome.
timeFrame: 14 days with 2 visits
measure: Part B Secondary Outcome.
timeFrame: 14 days with 2 visits
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: The Arizona Burn Center
state: Arizona
city: Orlando
country: United States
facility: The University of South Florida Board of Trustees
state: Florida
city: New York
country: United States
facility: Long Island Plastic Surgical Group
state: New York
city: Philadelphia
country: United States
facility: St. Chrisopher's Hospital for Children
state: Pennsylvania
Study officials:
affiliation: Drexel University College of Medicine
name: Paul Glat, Professor
role: PRINCIPAL_INVESTIGATOR
References: