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

NCT03984331 | Completed DMC FDA Device

• 2 other identifiers: KS-0340 - P2587CDMRP-MB150220
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Burns

Keywords

Fish skin; Full thickness burn; Burns; Cadaver Skin; Split Thickness Skin Graft; Temporary Cover; Blaze; Kerecis

Outcome Measures

Primary Outcomes (1)

• Proportions of wounds that have healed

  Wounds which have reached at least 95% epithelialization

  At 3 weeks days after STSG

Secondary Outcomes (11)

• Percentage of wound area exhibiting graft failure

  At 2 weeks after STSG

• Full epithelialization of wound

  At 2 weeks after STSG

• Scarring estimated with the Vancouver Scar Scale (VSS)

  At 12 months after STSG

• Inflammation profiling of wound punch biopsies as assessed by histology

  Before STSG, 2 and 3 weeks and 12 months after STSG

• Average number of antibiotics treatments per patient

  At all treatments appointments until 4 weeks after STSG

Study Arms (2)

Fish skin

EXPERIMENTAL

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

Cadaver skin

ACTIVE COMPARATOR

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

Interventions

Fish skin DEVICE

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.

Also known as: Marigen TM, Kerecis Omega3 Burn

Fish skin

Cadaver skin DEVICE

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.

Cadaver skin

Eligibility Criteria

• Age: 22 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)
• Female participants who are pregnant, breast feeding or planning pregnancy during the course of the clinical trial

Sponsors & Collaborators

• Kerecis Ltd.: lead
• MedStar Health: collaborator

Study Sites (1)

Burn Center at Medstar Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

MeSH Terms

Conditions

Burns; Ichthyosis Vulgaris

Condition Hierarchy (Ancestors)

Wounds and Injuries; Ichthyosis; Skin Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin Diseases, Genetic; Genetic Diseases, Inborn; Keratosis; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Jeffrey W. Shupp, MD

  Medstar Health Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 10, 2019
• First Posted: June 13, 2019
• Study Start: February 14, 2019
• Primary Completion: June 8, 2021
• Study Completion: September 21, 2021
• Last Updated: July 6, 2022

Record last verified: 2022-07

Locations

US (1)