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Completed

NCT Number: NCT02210208

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

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.

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Key information

Conditions

Burn Injury Burns Skin Graft Wounds and Injuries

Age range

18 month–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Arizona Burn Center, Phoenix, Arizona, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Part A

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.

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

Inclusion criteria

-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

  • 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

Treatment and study plan

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.

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.

Primary outcomes

  1. Part A: Number of Participants With Healing

    Time frame: 14 days

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

  2. Part B

    Time frame: 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 outcomes

  1. Part A Secondary Outcome.

    Time frame: 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.

  2. Part B Secondary Outcome.

    Time frame: 14 days with 2 visits

    Ability of Mepilex® Transfer Ag to adhere to donor site without slippage.

Sponsors and collaborators

Lead sponsor

Molnlycke Health Care AB

Industry

Registry information

Official study title

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.

Acronym: MpTAg03

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Aug 6, 2014
Registry last updated
Jan 10, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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