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Fish Skin Compared to Cadaver Skin as Temporary Cover for Full Thickness Burns (Kereburn)

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ClinicalTrials.gov Identifier: NCT03984331
Recruitment Status : Recruiting
First Posted : June 13, 2019
Last Update Posted : June 13, 2019
Sponsor:
Collaborator:
Medstar Health Research Institute
Information provided by (Responsible Party):
Kerecis Ltd.

Brief Summary:

Objectives and rationale: Optimal burn management involves removing all the dead or burned tissue as early as feasible and cover with an autograft called split thickness skin graft (STSG) taken from the patient. This procedure creates a new wound on the patient and sometimes, when the burn covers very large portion of the patient body, there is a lack of healthy skin to use for this purpose. Under those circumstances, donated cadaver skin is used as a temporary coverage until the patient´s own donor site wound has healed enough to be used again.

The proposed clinical study aims to determine if treatment with fish skin is an alternative to cadaver skin as a temporary coverage for debrided full-thickness burns prior to STSG in terms of autograft take, time to heal, quality of healing (scarring), pain and adverse effects.


Condition or disease Intervention/treatment Phase
Burns Device: Fish skin Device: Cadaver skin Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Two adjacent burn sites on the body of each burn patient will be randomized to receive initial early cover treatment after debridement with either fish skin or cadaver skin for 7± 3 days. After the initial 7± 3 days the test sites will be grafted with STSG.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: The burn wound trial area consists of two adjacent burn wound sites. The randomization will happen on the day of debridement. The test areas will be randomized to treatment so that one side receives early cover with fish skin and the other one with SOC. Treating physician will be aware of which product is being used on each site as temporary cover before grafting, but will not give this information to the patient. Prior to grafting, a blinded burn surgeon investigator will assess the burn wound bed. He/she will only have a subject number. The same procedure is used for the secondary endpoints of local reactions. Reassessment done by treating physician before STSG cannot be blinded as it is obvious what temporary treatment the test areas have received. Photos taken of wounds during the treatment (where products are not visible) will be judged blind by additional investigators. Scar assessment at 3 and 12 months via the Vancouver Scar Sale will also be fully blinded.
Primary Purpose: Treatment
Official Title: MariGen Fish Skin Compared to Cadaver Skin as a Temporary Covering for Full Thickness Burns: An Early Feasibility Trial
Actual Study Start Date : February 14, 2019
Estimated Primary Completion Date : September 30, 2019
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Burns

Arm Intervention/treatment
Experimental: Fish skin
All patients will receive both treatments, fish skin and cadaver skin, as early cover after early debridement. This group of wounds will receive only fish skin.
Device: Fish skin
One out of two adjacent burn sites of 10-20 cm x 7cm surface area will be randomized to receive fish skin as early cover. Each patient thus serves as his/her own control. After 7 +/- 3 days the burn site will receive a meshed split thickness skin graft.
Other Names:
  • Marigen TM
  • Kerecis Omega3 Burn

Active Comparator: Cadaver skin
All patients will receive both treatments, fish skin and cadaver skin, as early cover after early debridement. This group of wounds will receive only cadaver skin.
Device: Cadaver skin
One out of two adjacent burn sites of 10-20 cm x 7cm surface area will be randomized to receive cadaver skin as early cover. Each patient thus serves as his/her own control. After 7 +/- 3 days the burn site will receive a meshed split thickness skin graft.




Primary Outcome Measures :
  1. Proportions of wounds that have healed [ Time Frame: At 3 weeks days after STSG ]
    Wounds which have reached at least 95% epithelialization


Secondary Outcome Measures :
  1. Percentage of wound area exhibiting graft failure [ Time Frame: At 2 weeks after STSG ]
    The proportion of the wound area in which the graft does not take

  2. Full epithelialization of wound [ Time Frame: At 2 weeks after STSG ]
    Number of wounds fully epithelialized

  3. Scarring estimated with the Vancouver Scar Scale (VSS) [ Time Frame: At 12 months after STSG ]
    Vascularity (0-3), pigmentation (0-3), pliability (0-3), height (0-3), Total score;0=Best, 12=worst

  4. Inflammation profiling of wound punch biopsies as assessed by histology [ Time Frame: Before STSG, 2 and 3 weeks and 12 months after STSG ]
    Histological analysis of punch wound biopsies via standard H&E staining, or staining for known inflammatory markers (TNF-alpha, IL-1b, IL-6, IL-8)

  5. Average number of antibiotics treatments per patient [ Time Frame: At all treatments appointments until 4 weeks after STSG ]
    Average number of antibiotics treatments per patient

  6. Pain assessed by the Visual Analog Scale (VAS) before and after dressing changes [ Time Frame: At all treatments appointments until 3 weeks after STSG ]
    Pain by the Visual Analog Scale (VAS) on a scale of 0-10, 0=no pain, 10= pain as bad as it could be

  7. Bleeding time [ Time Frame: At all treatments appointments until 3 weeks after STSG ]
    Average time in seconds to achieve hemostasis during dressing changes

  8. Dermatitis [ Time Frame: At all treatments appointments until 3 weeks after STSG ]
    Incidence of dermatitis

  9. Ease-of-use [ Time Frame: Day 0 when grafts are initially applied after debridement ]
    Ease-of-use as judged by attending physician on a VAS scale of 0=extremely difficult to use to 10=Very easy to use

  10. Incidence of hematoma [ Time Frame: At all treatments appointments until 3 weeks after STSG ]
    Nr of wounds which develop a hematoma

  11. Inflammatory profiling of wound punch biopsies as assessed by mass spectrometry [ Time Frame: Before STSG, 2 and 3 weeks and 12 months after STSG ]
    Mass spectrometry analysis of punch wound biopsies, investigating known inflammatory markers (TNF-alpha, IL-1b, IL-6, IL-8)



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Ages Eligible for Study:   22 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participant or legally authorized representative is willing and able to give informed consent for participation in the clinical trial.

    • Patients from 22 to 75 years of age. Acute full thickness burn wounds outside the following areas; facial, genital and across joints, requiring widely meshed skin grafting or staging of STSG treatment due to insufficient healthy donor sites.
    • Maximal Total Body Surface Area (TBSA) of 50% full thickness burns
    • Able (in the Investigators opinion) and willing to comply with all clinical trial requirements.
    • Willing to allow his or her General Practitioner and consultant, if appropriate, to be notified of participation in the clinical trial.

Exclusion Criteria:

  • Declined consent

    • Immunocompromised patients or patients receiving immunosuppressive therapy
    • Presently participating in another clinical trial
    • Patient actively taking glucocorticoid or cytostatic medications
    • Persons with immune deficiency because of disease or iatrogenic-
    • Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the clinical trial, or may influence the result of the clinical trial, or the participant's ability to participate in the clinical trial.
    • Patient has known allergy to fish. (Shell fish allergy is not a contraindication)
    • Exclusion areas are, facial, genital and across joints.
    • Female participants who are pregnant, breast feeding or planning pregnancy during the course of the clinical trial

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03984331


Contacts
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Contact: Hilmar Kjartansson, MD 00354 5622666 hkj@kerecis.com
Contact: Marvin B. McBride III +1-571-317-5408 mbm@kerecis.com

Locations
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United States, District of Columbia
Burn Center at Medstar Washington Hospital Center Recruiting
Washington, District of Columbia, United States, 20010
Contact: Melissa M. Mclawhorn, MD    202-877-6181    Melissa.M.Mclawhorn@medstar.net   
Principal Investigator: Jeffrey W Shupp, MD         
Sub-Investigator: Laura Johnson, MD         
Sub-Investigator: Taryn Travis, MD         
Sponsors and Collaborators
Kerecis Ltd.
Medstar Health Research Institute
Investigators
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Principal Investigator: Jeffrey W. Shupp, MD Medstar Washington Hospital Center

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Responsible Party: Kerecis Ltd.
ClinicalTrials.gov Identifier: NCT03984331     History of Changes
Other Study ID Numbers: KS-0340 - P2587
CDMRP-MB150220 ( Other Grant/Funding Number: MBRP )
First Posted: June 13, 2019    Key Record Dates
Last Update Posted: June 13, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No

Keywords provided by Kerecis Ltd.:
Fish skin
Full thickness burn
Burns
Cadaver Skin
Split Thickness Skin Graft
Temporary Cover
Blaze
Kerecis

Additional relevant MeSH terms:
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Ichthyosis
Cadaver
Burns
Wounds and Injuries
Death
Pathologic Processes
Skin Abnormalities
Congenital Abnormalities
Infant, Newborn, Diseases
Keratosis
Skin Diseases