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

Molnlycke Health Care

Status: Completed

Conditions: Skin Graft; Burn Injury

Treatments: Device: Mepilex® Transfer Ag; Device: Mepitel® Ag

Study type: Interventional

Funder types: Industry

Identifiers

NCT02210208

MpTAg03

Details and patient eligibility

About

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.

Full 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.

Enrollment: 25 patients

Sex: All

Ages: 18 months to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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25 participants in 2 patient groups

Mepitel® Ag

Experimental group

Description:

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

Treatment:

Device: Mepitel® Ag

Mepilex® Transfer Ag

Experimental group

Description:

Donor site dressing device in the very same patient.

Treatment:

Device: Mepilex® Transfer Ag