A Single-stage Bilayered Skin Reconstruction With Glyaderm®
Condition: Burns; Full Thickness Burn; Necrotizing Fascitis
MeSH terms: Fasciitis; Fasciitis, Necrotizing; Burns
Study type: Interventional

Summary: 
      The study will explore the potential of utilizing Glyaderm® in a single-stage engrafting
      process, aiming for a more cost-effective approach. While the absence of the reticular dermal
      layer is a challenge associated with autologous split-thickness skin grafting (STSG), often
      leading to hypertrophic scars and contractures, various dermal substitutes with inconsistent
      results exist. Bilayered skin reconstruction using glycerolized acellular dermis (Glyaderm®)
      has shown promise in improving scar quality through a two-step procedure. However, unlike the
      typical two-step process required for most dermal substitutes, our investigation focuses on
      the cost-effective application of Glyaderm® in a single-stage engrafting. This approach, if
      successful, could offer advantages such as reduced costs, shorter hospitalization times, and
      lower infection rates-attributes preferred by many surgeons, especially when autografts are
      available.
    

Detailed description: 
      BACKGROUND. Patients suffering from severe burn injury are often confronted with
      life-threatening complications such as absence of the protective skin barrier which
      eventually lead to infections, sepsis and even death. The standard therapy for deep and full
      thickness burns consists of surgical debridement and coverage with autologous split thickness
      skin grafts (STSG) which normally results in a fast closure of the wounds contributing to an
      increased survival rate for burn victims. However, these thin skin grafts almost exclusively
      consist of epidermis only and due to the absence of most of the thicker dermal layer, which
      is crucial for the mechanical properties of the skin, the healing of these burn wounds
      inevitably results in hypertrophic and unaesthetic scar formation and contractures.
      Subsequently a long and difficult rehabilitation follows often with in the end poor aesthetic
      and functional long-term results and frequent psychological problems. Ideally, both skin
      layers (epidermis+dermis) should be reconstructed to improve the scar quality and therefore
      the quality of life after burns. As a consequence, dermal substitutes are necessary but the
      extremely high cost of all currently available dermal substitutes still is a major obstacle
      for its widespread application.

      SCIENTIFIC APPROACH. At the burn center of the Ghent University Hospital a significant amount
      lot of research has been targeted towards the development of a dermal substitute based on
      glycerolized allogenic skin grafts (Glyaderm). The use of human skin for dermal substitutes
      is ideal because the natural 3D network of collagen and elastin fibers is already provided
      and can be preserved. In order to prevent rejection our research group, together with the
      Euro Tissue Bank (ETB), developed a method of decellularization with a low concentration of
      sodium hydroxide (NaOH). Previous publications from our research team have demonstrated the
      beneficial effects of Glyaderm compared to STSG-only application. Unfortunately, our initial
      protocol required an additional surgical procedure to allow for optimal ingrowth of the
      dermal substitute before the STSG could be applied. This increased not only the time to
      healing but also the costs involved. Within the last two years a pilot study has demonstrated
      that further optimization of the substitute and of the procedure resulted in a successful
      simultaneous application of Glyaderm and STSG. The scientific objective of this project is to
      obtain the necessary clinical evidence for this improved applicability of Glyaderm in deep
      burns or full thickness skin defects by providing a bilayered reconstruction of the skin with
      simultaneous application of this dermal substitute combined with a STSG in a one surgical
      procedure. The scientific approach will consist of performing a large prospective,
      controlled, randomized, intra-individual comparative clinical study, investigating
      simultaneous application of Glyaderm + STSG versus STSG alone in deep burns and other full
      thickness skin defects. Power calculation determined that a total of 75 patients must be
      included: both early outcome parameters (graft take, ingrowth, and time to healing) as well
      as late outcome measurements (scar characteristics, quality of life, histology) will be
      evaluated up to 12 months post burn.

      UTILIZATION. A recent report of the Kennis Centrum/Centre d'Expertise (KCE) demonstrated that
      each year more than 2500 (severely) burned patients are admitted to a Belgian hospital or
      burn center with the majority of them requiring surgical therapy (ref). The utilization
      objective of this project is to make Glyaderm universally available for the treatment of
      patients with deep burns or other full thickness skin defects. This effective, low-cost and
      easy-to-use dermal substitute should facilitate the patient's rehabilitation by providing a
      more aesthetic scar formation with less functional impairment. The ultimate goal is an
      improved quality of life for the patient with a better reintegration of the burn victims into
      society. Our utilization strategy will focus on the actual application of the study results
      for the patient's well-being and an important role hereby is reserved for the Advisory
      Committee. For this purpose we have extended an already existing network of major
      stakeholders who all are committed to the clinical utilization process. Included in this
      group are representatives of: patients' self-help groups, the Belgian Burn Foundation, an
      inter-mutualistic committee, a representative from the RIZIV (national health care
      reimbursement organization), of health economics and from Belgian and Dutch tissue banks. If
      indeed the results of our clinical study demonstrate an improved aesthetic and functional
      outcome as well as a significant reduction in time to heal and operative costs, then this
      should eventually lead to a better reimbursement, even in the current era of budget
      restrictions. Implementation of Glyaderm as a readily-available and easy to use
      reconstructive tool into the existing armamentarium of the surgeon will be realized through
      workshops, training courses as well as presentation in national and international congresses.

      The ultimate goal is to establish a universal application of this cost-effective dermal
      substitute in Flanders and due to the simplicity of the decellularization procedure also
      throughout Belgium and even worldwide. Glyaderm could be used on all aesthetically or
      functionally important places and even more so in children and in economically disadvantaged
      patients.
    

Intervention name(s): Dermal subsitute Glyaderm + skin graft; Skin graft alone
Intervention type(s): Procedure; Procedure
Intervention description(s): A human donor-derived dermal substitute will be implanted together with a skin graft; Skin graft alone with no dermal substitute
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A prospective, randomized, controlled, intra-individual, single-blinded study in a mono-center setting
Masking: Single (Participant)
Primary purpose: Treatment