CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 30 enrolled
Drug / intervention
DE graft and PRP concentrate +1 moreprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01383187
NCT01383187Phase 3Completed

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

University Hospital Ostrava·interventional·Posted Jun 28, 2011·Updated Mar 22, 2013

In Brief

A Phase 3 clinical trial evaluating DE graft and PRP concentrate and DE graft for Burns. Completed, enrolled 30 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBurns
CountriesCzechia
Collaborators--

Timeline

Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedJun 28, 2011
Enrollment StartNov 1, 2008
Primary CompletionNov 1, 2011
Study CompletionDec 1, 2011
TodayJul 2, 2026
Enrollment to primary: 3 yearsPosted 15.0 years ago

Interventions

DE graft and PRP concentrateprocedure

Application of DE graft together with PRP concentrate

DE graftprocedure

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