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

NCT ID: NCT02210208

Last Updated: 2018-01-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-30
• Study Completion Date: 2016-06-15

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.

Conditions

Burn Injury; Skin Graft

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Mepitel® Ag

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

Group Type: EXPERIMENTAL

Mepitel® Ag

Intervention Type: DEVICE

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.

Mepilex® Transfer Ag

Donor site dressing device in the very same patient.

Group Type: EXPERIMENTAL

Mepilex® Transfer Ag

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

Eligibility Criteria

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.

-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

• 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

• 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

• Minimum Eligible Age: 18 Months
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Molnlycke Health Care AB

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Paul Glat, Professor

Role: PRINCIPAL_INVESTIGATOR

Drexel University College of Medicine

Locations

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

Countries

United States

Other Identifiers

MpTAg03

Identifier Type: -

Identifier Source: org_study_id