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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01383187
First Posted: June 28, 2011
Last Update Posted: March 22, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University Hospital Ostrava
  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
Intervention Model: Parallel Assignment
Masking: None (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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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.

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
  More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University Hospital Ostrava
ClinicalTrials.gov Identifier: NCT01383187     History of Changes
Other Study ID Numbers: 99-OVZ-09-024
First Submitted: June 21, 2011
First Posted: June 28, 2011
Last Update Posted: March 22, 2013
Last Verified: March 2013

Keywords provided by University Hospital Ostrava:
Deep Burn Trauma
Dermo-Epidermal Graft
Platelet Rich Plasma Concentrate (PRP)
Vancouver Scar Score
Scarring
Hypertrophic Scarring

Additional relevant MeSH terms:
Burns
Wounds and Injuries
Thrombin
Hemostatics
Coagulants