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An Open Single-centre Investigation Evaluating Efficacy in Second Degree Partial Thickness Burns Using a Silicone Contact Layer Containing Silver.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Molnlycke Health Care AB
ClinicalTrials.gov Identifier:
NCT01734317
First received: November 22, 2012
Last updated: May 14, 2013
Last verified: February 2013
History of Changes
  Purpose

Approximately 10 subjects from one clinic having sustained a burn injury covering 1-25% or the Total Body surface Area (TBSA)and assessed as superficial partial-thickness or superficial deep-partial-thickness. The subject will be assessed once a week for a maximum of 3 weeks or until the burn is healed if that occurs earlier. . The dressing Mepilex Transfer Ag will be used as wound contact layer and gauze rolls and compression as second dressing.


Condition Intervention
Wound Healing
 Device: Mepilex Transfer Ag

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open, Non Controled, Single-centre, Clinical Investigation to Evaluate Efficacy in Second Degree (Superficial, Deep or Mixed) Partial Thickness Burns When Using a Soft Silicone Wound Contact Ayer Containing Silver.

Resource links provided by NLM:

MedlinePlus related topics: Burns
U.S. FDA Resources

Further study details as provided by Molnlycke Health Care AB:

Primary Outcome Measures:
  • Efficacy [ Time Frame: 14 days ] [ Designated as safety issue: No ]
    Proportion of subjects healed at day 14. Healing will be defined as ≥95% epithelialisation.

  • Efficacy [ Time Frame: 21 days ] [ Designated as safety issue: No ]
    Subjects not healed after 14 days will be assessed at day 21.


Secondary Outcome Measures:
  • Pain [ Time Frame: After 14/21 days treatment ] [ Designated as safety issue: No ]
    Pain before, during and after dressing removal will be meausered.


Enrollment: 10
Study Start Date: October 2012
Study Completion Date: February 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dressing
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.
 Device: Mepilex Transfer Ag
A soft silicone wound contact layer.

Detailed Description:

Approximately 10 subjects from one site will be evaluated provided they fulfill the inclusion criteria and none of the exclusion criteria and gives a signed and dated consent.

Subjects may have sustained a burn injury covering 1-25% of the Total Body Surface Area (TBSA)and assessed as superficial partial-thickness or superficial deep-partial thickness in dept. Each subject will be followed one time per week for a maximum of 3 weeks or until the burn is healed if that occurs earlier. Healing is defined as ≥95% epithelialisation. Percent (%) healed epithelialization will be measured by photo analysing using the PictZar program. Dressing changes will be performed at each visit and in between if deemed necessary by the investigator.Gauze rolls and compression will be used as secondary dressing.All dressing changes will be registered in a log. Pain before, during and after removal will be assessed.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject with a second degree (superficial, deep or mixed) partial thickness burn from 1-25% TBSA.
  • One single, isolated burn area selected for study site Study site area should be between 1-15% BSA
  • Male or female
  • From 18 years and above
  • Either in- or out-patient
  • Thermal burn injury
  • Signed Informed Consent/Assent Form

Exclusion Criteria:

  • Electrical, chemical burn etiology
  • If any full thickness areas are present, these should not be > 5 %
  • Burn greater than 36 hrs old
  • Burns to face
  • Use of chemical/enzymatic and biological debridement within 7 days of investigation start
  • Presence of inflammation or infection in burn wounds
  • Use of topical antibiotics, antiseptics, or antimicrobials in conjunction with study product.
  • Subjects with lung injury or Subject being on a ventilator
  • Subjects with dermatologic skin disorders or necrotizing processes
  • Subjects with insulin dependent diabetes mellitus judged by the investigator to be a potential interference in the treatment
  • Diagnosed underlying disease(s) (e.g HIV/AIDS, cancer and severe anaemia) judged by the investigator to be a potential interference in the treatment
  • Subject not expected to follow the investigation procedures
  • Subjects previously included in this investigation
  • Subjects included in other ongoing clinical investigation at present or during the past 30 days
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01734317

Locations
United States, Florida
Florida Gulf-to-bay Anesthesiology
Tampa, Florida, United States, 33606
United States, New York
Long Island Plastic Surgical Group, P.C
Garden City, New York, United States, 11530
Sponsors and Collaborators
Molnlycke Health Care AB
Investigators
Principal Investigator: Hans Schweiger, MD Florida Gulf-toBay Anesthesiology, Tampa Bay Circle
  More Information

No publications provided

Responsible Party: Molnlycke Health Care AB
ClinicalTrials.gov Identifier: NCT01734317     History of Changes
Other Study ID Numbers: MxT Ag 02
Study First Received: November 22, 2012
Last Updated: May 14, 2013
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on June 17, 2013