Fish Skin Compared to Cadaver Skin as Temporary Cover for Full Thickness Burns
Condition: Burns
MeSH terms: Ichthyosis; Cadaver; Burns
Study type: Interventional

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.
    

Detailed description: 
      Mortality after severe burns has diminished during the last decades and survival is no longer
      considered the primary end point of care. More attention is paid to the final functional and
      cosmetic outcome of the affected area but outcomes are still far from optimal. For the time
      being, one of the main goals in burn treatment is to achieve reduced scar formation from the
      time of injury. A temporary or permanent covering of the wound bed should be achieved at the
      time of excision. In burn wounds the gold standard is to use split thickness skin graft, or
      STSG, which includes epidermis, basement membrane, and a part of upper dermis. Yet the use of
      skin grafts has many shortcomings: there is only a limited amount of skin available for
      grafting, the donor sites are susceptible to infections, to pain, to pigmentation changes,
      and to scarring especially when re harvested. Therefore, for complicated burns, initial
      treatment is often with temporary coverage where cadaver skin has been the accepted standard
      of care.

      In recent years there has been progress in the development of advanced wound care products.
      This has resulted in a third generation of wound treatment, known as acellular dermal grafts
      or skin substitutes.

      Aims The goal of this clinical trial is to demonstrate that fish skin is an alternative to
      cadaver skin as early cover before STSG in burn wounds. This trial will be open to patients
      who are scheduled to receive meshed STSG of any ratio. Fish skin or cadaver skin will be
      applied after initial debridement in order to prepare the wound area for STSG.

      5 to 10 patients will be prospectively enrolled and two burn sites on their body will
      randomized to initial treatment after debridement with either fish skin or cadaver skin for
      7+/-3 days. After the initial treatment, the test sites will be grafted with STSG.

      The histological differences and the functional outcomes will be assessed for 12 months.

      Products will be applied by experienced burn surgeons at a burn center. At approximately Day
      7, or when the treating physician deems the wound to be ready for grafting, the products will
      be removed. Prior to grafting, a second blinded burn surgeon will assess the burn wound bed.

      Important dates for blinding are on Day 7 prior to STSG treatment and on Days 14, 21 and 28
      for graft take, epithelialisation and wound closure. Scar assessment at 3 and 12 months via
      the Vancouver Scar Sale will also be fully blinded.

      Key interventions:

      Randomized to either cadaver skin or fish skin after initial debridement Two areas each of
      10-20 x 7 cm side by side. Other areas will be treated as per local Standard of care (SOC).
      Concomitant medications will be given, e.g. painkiller, antibiotics, as needed.

      Wound dressings changed approximately every three days until allograft or xenograft removal.

      Approximately one week after placement the fish skin and cadaver allografts removed as
      required.

      Subsequent meshed autograft placement if donor sites are available. Autografts covered with
      secondary antimicrobial/silver dressing and dressings approximately every 3 days until
      healed.

      Autografts monitored for adherence, color, autograft take, and visual signs of infection.

      During the operation, a 3 or 4 mm punch biopsy will be harvested from the excised wound bed
      before covering with any material.
    

Intervention name(s): Fish skin; Cadaver skin
Intervention type(s): Device; Device
Intervention description(s): 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.; 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.
Other intervention name(s): Marigen TM; Kerecis Omega3 Burn
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)
Primary purpose: Treatment
Keywords: Fish skin; Full thickness burn; Burns; Cadaver Skin; Split Thickness Skin Graft; Temporary Cover; Blaze; Kerecis