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

NCT02210208 | Completed Results

• 1 other identifier: MpTAg03
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 4

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.

Conditions

Burn Injury; Skin Graft

Outcome Measures

Primary Outcomes (2)

• Part A: Number of Participants With Healing

  Part A: Adequate take of skin graft (defined as at least 95% adherent and healed as assessed by clinical investigator).

  14 days

• Part B

  Part B: The healing percentage of donor sites (defined as greater than 95% epithelialization, verified by quantitative photographic analysis).

  14 days with 2 visits

Secondary Outcomes (2)

• Part A Secondary Outcome.

  14 days with 2 visits

• Part B Secondary Outcome.

  14 days with 2 visits

Study Arms (2)

Mepitel® Ag

EXPERIMENTAL

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

Device: Mepitel® Ag

Mepilex® Transfer Ag

EXPERIMENTAL

Donor site dressing device in the very same patient.

Device: Mepilex® Transfer Ag

Interventions

Mepitel® Ag 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.

Mepitel® Ag

Mepilex® Transfer Ag 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.

Mepilex® Transfer Ag

Eligibility Criteria

• Age: 18 Months - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• There must be healthy, intact peri-wound skin surrounding the planned donor site to allow for adequate overlap of study product (5 cm)

Sponsors & Collaborators

• Molnlycke Health Care AB: lead

Study Sites (4)

The Arizona Burn Center

Phoenix, Arizona, 85008, United States

Location

The University of South Florida Board of Trustees

Orlando, Florida, 32886-4687, United States

Location

Long Island Plastic Surgical Group

New York, New York, 11530, United States

Location

St. Chrisopher's Hospital for Children

Philadelphia, Pennsylvania, 19134, United States

Location

MeSH Terms

Conditions

Burns

Condition Hierarchy (Ancestors)

Wounds and Injuries

Results Point of Contact

• Title: Global Clinical Research Director
• Organization: Mölnlycke Health Care

info@monlycke.com

+46 31 722 30 00

Study Officials

• Paul Glat, Professor

  Drexel University College of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Two Parts (part A and B) with one dressing device for the skin graft placed on a surgical burn wound and another dressing device placed on the donor site.

Study Record Dates

• First Submitted: August 5, 2014
• First Posted: August 6, 2014
• Study Start: September 1, 2014
• Primary Completion: June 1, 2016
• Study Completion: June 15, 2016
• Last Updated: January 10, 2018
• Results First Posted: August 2, 2017

Record last verified: 2017-12

Locations

US (4)