Autologous Platelets Concentrate and Autologous Thrombin for the Treatment of Deep Burn Trauma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Hospital Ostrava
ClinicalTrials.gov Identifier:
NCT01383187
First received: June 21, 2011
Last updated: March 21, 2013
Last verified: March 2013
  Purpose

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.


Condition Intervention Phase
Burns
Procedure: DE graft and PRP concentrate
Procedure: DE graft
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-label, Non Randomized, Single-Center Registry Study to Assess the Safety and Effects of Autologous Platelets Concentrate and Autologous Thrombin for the Treatment of Deep Burns Trauma

Resource links provided by NLM:


Further study details as provided by University Hospital Ostrava:

Primary Outcome Measures:
  • Healing assessed on Vancouver Scar Score [ Time Frame: 1st, 3rd, 6th month, 1 and 2 years after surgery ] [ Designated as safety issue: No ]
    Vancouver Scar Score is a worldwide measurement tool for assessment of the healing process in the patients with deep burn trauma. It presents us with information regarding the overall healing process.


Secondary Outcome Measures:
  • Percentage of healing [ Time Frame: 4th, 6th, 8th, 10th, 12th, 14th, 16th, 18th day after surgery ] [ Designated as safety issue: No ]
    The measurements are taken at intervals after the surgical treatment, the calculated data show the percentage of healing compared to the total surgery treatment area (STA) which has been treated with the DE graft and PRP concentrate.

  • Vitality of the DE graft [ Time Frame: 2nd, 4th, 6th, 8th, 10th and 14th post-operative day ] [ Designated as safety issue: No ]
    The vitality of the DE graft assessed on a scale enables us to measure the success of the healing process.

  • Epithelization of the DE graft [ Time Frame: 2nd, 4th, 6th, 8th, 10th and 14th post-operative day ] [ Designated as safety issue: No ]
    The degree of epithelization assessed on a scale enables us to measure the success of the healing process.

  • Harvesting surface area [ Time Frame: 2nd, 4th, 6th, 8th, 10th and 14th post-operative day ] [ Designated as safety issue: No ]
    The state of the harvesting degree area enables us to measure the success of the healing process.


Enrollment: 30
Study Start Date: November 2008
Study Completion Date: December 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: DE graft and PRP concentrate
Patients enrolled in this arm receive the innovative treatment methods consisting of application of DE graft together with PRP concentrate.
Procedure: DE graft and PRP concentrate
Application of DE graft together with PRP concentrate
Active Comparator: Standard treatment group
PAtients included into this arm will receive a standard treatment for deep-burn injuries, i.e. DE graft without the application of the PRP concentrate.
Procedure: DE graft
DE grafting presents a standard treatment method in patients with deep-burn trauma.

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  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • adult patient (over 18 years old) with deep burn injury indicated for surgery treatment - surgical excisions of devitalised tissue followed by dermoepidermal transplantation
  • signed patient´s informed consent

Exclusion Criteria:

  • inborn thrombocytopaenia
  • haematological malignities
  • chronic renal failure (deficiency of platelet´s growth factors)
  • not signed patient´s informed consent
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01383187

Locations
Czech Republic
University Hospital Ostrava
Ostrava-Poruba, Czech Republic, 708 52
Sponsors and Collaborators
University Hospital Ostrava
Investigators
Principal Investigator: Hana Klosova, MD University Hospital,Ostrava Czech Republic