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

Not Applicable

Completed

• Conditions: Burn Injury; Skin Graft
• Interventions: Device: Mepilex® Transfer Ag; Device: Mepitel® Ag

• Registration Number: NCT02210208
• Lead Sponsor: Molnlycke Health Care AB

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.

Study Timeline

• Study First Submitted: 2014-08-05
• Study First Submitted QC: 2014-08-05
• Study First Posted: 2014-08-06
• Study Start: 2014-09
• Primary Completion: 2016-06
• Study Completion: 2016-06-15
• Results First Submitted: 2017-07-05
• Results First Submitted QC: 2017-07-05
• Results First Posted: 2017-08-02
• Status Verified: 2017-12
• Last Update Submitted: 2017-12-12
• Last Update Posted: 2018-01-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mepilex® Transfer Ag	Mepilex® Transfer Ag	Donor site dressing device in the very same patient.
Mepitel® Ag	Mepitel® Ag	A dressing device used for surgical burn wounds with skin graft.

Primary Outcome Measures

Name	Time	Method
Part A: Number of Participants With Healing	14 days	Part A: Adequate take of skin graft (defined as at least 95% adherent and healed as assessed by clinical investigator).
Part B	14 days with 2 visits	Part B: The healing percentage of donor sites (defined as greater than 95% epithelialization, verified by quantitative photographic analysis).

Secondary Outcome Measures

Name	Time	Method
Part A Secondary Outcome.	14 days with 2 visits	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.
Part B Secondary Outcome.	14 days with 2 visits	Ability of Mepilex® Transfer Ag to adhere to donor site without slippage.

Trial Locations

Locations (4)

The Arizona Burn Center; 🇺🇸 Phoenix, Arizona, United States

The University of South Florida Board of Trustees; 🇺🇸 Orlando, Florida, United States

Long Island Plastic Surgical Group; 🇺🇸 New York, New York, United States

St. Chrisopher's Hospital for Children; 🇺🇸 Philadelphia, Pennsylvania, United States