Autologous Platelets Concentrate and Autologous Thrombin for the Treatment of Deep Burn Trauma
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|ClinicalTrials.gov Identifier: NCT01383187|
Recruitment Status : Completed
First Posted : June 28, 2011
Last Update Posted : March 22, 2013
|Condition or disease||Intervention/treatment||Phase|
|Burns||Procedure: DE graft and PRP concentrate Procedure: DE graft||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||November 2008|
|Actual Primary Completion Date :||November 2011|
|Actual Study Completion Date :||December 2011|
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.
- 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.
- 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.
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
|University Hospital Ostrava|
|Ostrava-Poruba, Czech Republic, 708 52|
|Principal Investigator:||Hana Klosova, MD||University Hospital Ostrava|