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

NCT01383187 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2013-03-22

No results posted yet for this study

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.

Conditions

  • Burns

Interventions

PROCEDURE

DE graft and PRP concentrate

Application of DE graft together with PRP concentrate

PROCEDURE

DE graft

DE grafting presents a standard treatment method in patients with deep-burn trauma.

Sponsors & Collaborators

  • University Hospital Ostrava

    lead OTHER

Principal Investigators

  • Hana Klosova, MD · University Hospital Ostrava

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-11-30
Primary Completion
2011-11-30
Completion
2011-12-31

Countries

  • Czechia

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01383187 on ClinicalTrials.gov