A Soft Silicone Wound Contact Layer Containing Silver in the Treatment of

Status Completed

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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02210208
Study type	Interventional
Source	Molnlycke Health Care AB
Contact
Status	Completed
Phase	N/A
Start date	September 2014
Completion date	June 15, 2016

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See also
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A Soft Silicone Wound Contact Layer Containing Silver in the Treatment of Skin Grafts in Surgical Burn Patients. — MpTAg03

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms