NCT02210208

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

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.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Molnlycke Health Care AB · Industry
• Sex: All
• Age: 18 Months – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Burn Injury
• Skin Graft

Interventions

Type	Name	Description
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.
DEVICE	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.

Timeline

• Start date: 2014-09-01
• Primary completion: 2016-06-01
• Completion: 2016-06-15
• First posted: 2014-08-06
• Last updated: 2018-01-10
• Results posted: 2017-08-02

Locations

4 sites across 1 country: United States