Autologous Platelets Concentrate and Autologous Thrombin for the Treatment of Deep Burn Trauma
Condition: Burns
MeSH terms: Burns
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Deep skin burn injuries, especially extensive deep burns or/and deep burns extending on the
      face, hands, feet, genitalia and perineum, remain one of the most challenging therapeutic
      problems. Surgical excision of the necrotic burned tissue with subsequent skin grafting of
      the affected area has become the golden standard for the treatment of deep partial thickness
      and full thickness skin burns and represents the treatment of choice. Despite of all the
      progress achieved in the treatment process (artificial skin, cultured keratinocytes), the
      therapeutic results are sometimes unacceptable due to functional and cosmetic deficits
      causing severe psychological and emotional distress, particularly in the form of disfiguring
      and disabling scarring - i.e. hypertrophic scars, joint contractures restricted movement,
      peripheral neuropathy, psychiatric and physiological diseases, as well as thermoregulation
      disorders. Consequently, the quality of life is markedly decreased. That is why new methods
      of burn wounds covering are intensively searched. Based upon the results of available
      pre-clinical studies, the local use of autologous platelet concentrate with their active
      growth factors appears to be a good and promising possibility how to improve faster and
      higher quality of healing deep skin burn wounds.
    

Detailed description: 
      Deep skin burn injuries(i.e. third-degree and deep second-degree burns), especially extensive
      deep burns or /and deep burns extend on the face, hand, feet, genitalia and perineum remain
      one the most challenging problem for modern medicine because of its difficult, complicated
      and long clinical course and recovery. Extensive deep burn injury is, in despite of all
      progress in treatment, ordinarily associated with shock, infection, MODS, electrolyte
      imbalance, respiratory distress,… with high morbidity and mortality rate. Regardless of the
      extent,burns are likewise very painful with necessity to treat pain in the majority of
      patient, comprehensive treatment and wound management of deep burns often demand confinement
      to bed, splinting, special positioning - patients are some point of time unable care of
      themselves and restrict in their habitual life pattern. Despite of all the progress achieved
      in the treatment process, therapeutic results sometimes are unacceptable due to functional
      and cosmetic deficits causing severe psychological and emotional distress, particularly due
      to scarring and physical deformity - i.e. hypertrophic scars, joint contractures, peripheral
      neuropathy, psychiatric and psychological diseases, as well as thermoregulation disorders.
      Consequently the quality of life may be markedly decreased. That is why the new methods of
      burn wounds covering are intensively searched. Based upon the results of available
      pre-clinical studies, the local use of autologous platelet concentrate with their active
      growth factors appears to be a good possibility how to improve faster and higher quality of
      healing deep skin burn wounds.

      To achieve the best possible therapeutic results the accurate diagnosis of depth of skin
      destruction and depending on that the accurate choice of treatment strategy is fundamental.
      The standard method for the determination of burn depth is clinical examination. Presence of
      the eschar, i.e. evidently devitalised tissue, means necessity of surgical treatment and the
      clinical diagnosis is obvious. The accurate clinical assessment of the deep dermal
      burns,which may sometimes healing spontaneously until 21 days without surgical treatment, is
      in most of cases complicated and controversial. If the healing until 21 days is not complete
      or the possibility of spontaneous healing is improbable, the surgical treatment is indicated.
      In these controversial cases the dominant role plays above all clinical experiences and
      diagnostic capabilities of examining burn´s surgeon. Indication of surgical treatment here
      directly depends on human factor and is related with the risk of incorrect decision. Despite
      of the fact that there is no generally accepted physical diagnostic method to detect the
      depth of burns, there are some objective methods how to improve the accuracy of diagnosis and
      their using in parallel with clinical observations is desirable. In our Burn centre the
      investigators use the laser Doppler method to determine the depth of burns by means of
      apparatus LDPI PIM III (Perimed Co, Jarfalla,Sweden). This device detects skin perfusion and
      its changes in the course of time. Third degree burns have a very low levels of skin
      perfusion and in course of time there is no increase of perfusion units on measured areas.
      Deep second degree burns with presumption of spontaneous healing within 14 - 21 days show
      continued increase of perfusion units from the second to ninth day post-injury. Deep second
      degree burns with healing time longer than 21 days show minimal or no increase of perfusion
      units from second to eleventh post-injury day. Current treatment of deep burns consists of
      surgical excision of necrotic tissue followed by dermoepidermal skin autografting. Central
      role of platelets in haemostatic and thrombotic process is well known. This is due to many
      clotting and growth factors stored in platelet granules. The successful use of the autologous
      platelet rich plasma (PRP), i.e. Autologous Platelet Concentrate (APC) to improve healing has
      been recently tested in limited in vivo and lately in a few clinical trial as well, however
      no published study to our knowledge has tested APC for the treatment of deep skin burns in
      humans. Based on data from published literature and our limited clinical experience with the
      use of APC to treat severe skin ulcerations, the investigators would like to use this knew
      experimental treatment in our patient population suffering from deep skin burns.

        1. third-degree burns, i.e. full thickness burns involve all the layers of skin.

        2. fourth-degree burns - when muscle, bone and blood vessels also be injured.

      2/ deep second-degree burns, i.e. burns involved damage of the epidermis and deep part of the
      dermis layer of skin. Deep second-degree burns can sometimes heal spontaneously, however in
      cases when the investigators supposed the healing takes longer than three weeks, the
      investigators indicate surgical treatment for optimal functional and cosmetic results.

      Surgical excision of devitalised burned tissue with subsequent skin grafting on the basis of
      longtime clinical experiences has become the golder standard for the treatment of deep
      partial thickness and full thickness skin burns in generally and represents the treatment of
      choice in our Burn center.In order to achieve the best therapeutic results,i.e.
      un-complicated,quick and high quality healing, the new methods of burn wounds covering are
      intensively searched. One of many possibilities is topical transplantation of APC,
      successfully used in many surgical fields about twenty years, but still widely uncertified in
      clinical practice of burn´s medicine.

      A concentrate of autologous thrombocytes - Autologous Platelet Concentrate (APC) is applied
      locally in the area of autotransplanted surfaces. The applied growth factors initiate
      chemotaxis, proliferation, angiogenesis, proteosynthesis, reparation and remodeling of the
      impaired tissue (najít citaci). The elevated concentration of growth factors in the area of
      the lesion will significantly speed up the process of reparation and regeneration - the
      inflammatory phase is reduced, leukocytes and their cytokines, as well as interleukins are
      present only in normal, non-elevated concentrations (uvést odkaz). The damaged tissue heals
      with markedly reduced swelling and the pain is also unambiguously(jednoznačně) reduced which
      is in virtue of less nociceptive afferentation. The antioedematous effect seems to be the
      result of an earlier angiogenesis, weak antiendothelial bounds with elevated permeability of
      proteins and erythrocytes into extracellular space are quickly replaced with adequate
      endothelial layer, due to the proliferation of endothelium. The healing process is completed
      with a remodeling of the scar, together with an anticipated reduction of hypertrophic
      scarring.
    

Intervention name(s): DE graft and PRP concentrate; DE graft
Intervention type(s): Procedure; Procedure
Intervention description(s): Application of DE graft together with PRP concentrate; DE grafting presents a standard treatment method in patients with deep-burn trauma.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Deep Burn Trauma; Dermo-Epidermal Graft; Platelet Rich Plasma Concentrate (PRP); Vancouver Scar Score; Scarring; Hypertrophic Scarring