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BurnsPhase 2/3NCT01383187

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

A Phase 2/3 study testing DE graft and PRP concentrate and DE graft in people with Burns, run by University Hospital Ostrava at 1 site in Czechia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Burns
What is being tested?
DE graft and PRP concentrate and DE graft
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteCzechia
Study dates
Nov 2008to Dec 2011
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • inborn thrombocytopaenia
  • haematological malignities
  • chronic renal failure (deficiency of platelet´s growth factors)
  • not signed patient´s informed consent

Trial locations and contacts

1 site in 1 country.

Czechia1 site
  • University Hospital Ostrava

    Ostrava-Poruba, Czech Republic, 708 52

Other trials in Czechia

About this study

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

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.

Read the detailed description

Deep skin burn injuries(i.e. third-degree and deep second-degree burns), especially extensive deep burns or /and deep burns extend on the face, hand, feet, genitalia and perineum remain one the most challenging problem for modern medicine because of its difficult, complicated and long clinical course and recovery. Extensive deep burn injury is, in despite of all progress in treatment, ordinarily associated with shock, infection, MODS, electrolyte imbalance, respiratory distress,… with high morbidity and mortality rate. Regardless of the extent,burns are likewise very painful with necessity to treat pain in the majority of patient, comprehensive treatment and wound management of deep burns often demand confinement to bed, splinting, special positioning - patients are some point of time unable care of themselves and restrict in their habitual life pattern. Despite of all the progress achieved in the treatment process, therapeutic results sometimes are unacceptable due to functional and cosmetic deficits causing severe psychological and emotional distress, particularly due to scarring and physical deformity - i.e. hypertrophic scars, joint contractures, peripheral neuropathy, psychiatric and psychological diseases, as well as thermoregulation disorders. Consequently the quality of life may be markedly decreased. That is why the 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 possibility how to improve faster and higher quality of healing deep skin burn wounds.

To achieve the best possible therapeutic results the accurate diagnosis of depth of skin destruction and depending on that the accurate choice of treatment strategy is fundamental. The standard method for the determination of burn depth is clinical examination. Presence of the eschar, i.e. evidently devitalised tissue, means necessity of surgical treatment and the clinical diagnosis is obvious. The accurate clinical assessment of the deep dermal burns,which may sometimes healing spontaneously until 21 days without surgical treatment, is in most of cases complicated and controversial. If the healing until 21 days is not complete or the possibility of spontaneous healing is improbable, the surgical treatment is indicated. In these controversial cases the dominant role plays above all clinical experiences and diagnostic capabilities of examining burn´s surgeon. Indication of surgical treatment here directly depends on human factor and is related with the risk of incorrect decision. Despite of the fact that there is no generally accepted physical diagnostic method to detect the depth of burns, there are some objective methods how to improve the accuracy of diagnosis and their using in parallel with clinical observations is desirable. In our Burn centre the investigators use the laser Doppler method to determine the depth of burns by means of apparatus LDPI PIM III (Perimed Co, Jarfalla,Sweden). This device detects skin perfusion and its changes in the course of time. Third degree burns have a very low levels of skin perfusion and in course of time there is no increase of perfusion units on measured areas. Deep second degree burns with presumption of spontaneous healing within 14 - 21 days show continued increase of perfusion units from the second to ninth day post-injury. Deep second degree burns with healing time longer than 21 days show minimal or no increase of perfusion units from second to eleventh post-injury day. Current treatment of deep burns consists of surgical excision of necrotic tissue followed by dermoepidermal skin autografting. Central role of platelets in haemostatic and thrombotic process is well known. This is due to many clotting and growth factors stored in platelet granules. The successful use of the autologous platelet rich plasma (PRP), i.e. Autologous Platelet Concentrate (APC) to improve healing has been recently tested in limited in vivo and lately in a few clinical trial as well, however no published study to our knowledge has tested APC for the treatment of deep skin burns in humans. Based on data from published literature and our limited clinical experience with the use of APC to treat severe skin ulcerations, the investigators would like to use this knew experimental treatment in our patient population suffering from deep skin burns.

  1. third-degree burns, i.e. full thickness burns involve all the layers of skin.
  2. fourth-degree burns - when muscle, bone and blood vessels also be injured.

2/ deep second-degree burns, i.e. burns involved damage of the epidermis and deep part of the dermis layer of skin. Deep second-degree burns can sometimes heal spontaneously, however in cases when the investigators supposed the healing takes longer than three weeks, the investigators indicate surgical treatment for optimal functional and cosmetic results.

Surgical excision of devitalised burned tissue with subsequent skin grafting on the basis of longtime clinical experiences has become the golder standard for the treatment of deep partial thickness and full thickness skin burns in generally and represents the treatment of choice in our Burn center.In order to achieve the best therapeutic results,i.e. un-complicated,quick and high quality healing, the new methods of burn wounds covering are intensively searched. One of many possibilities is topical transplantation of APC, successfully used in many surgical fields about twenty years, but still widely uncertified in clinical practice of burn´s medicine.

A concentrate of autologous thrombocytes - Autologous Platelet Concentrate (APC) is applied locally in the area of autotransplanted surfaces. The applied growth factors initiate chemotaxis, proliferation, angiogenesis, proteosynthesis, reparation and remodeling of the impaired tissue (najít citaci). The elevated concentration of growth factors in the area of the lesion will significantly speed up the process of reparation and regeneration - the inflammatory phase is reduced, leukocytes and their cytokines, as well as interleukins are present only in normal, non-elevated concentrations (uvést odkaz). The damaged tissue heals with markedly reduced swelling and the pain is also unambiguously(jednoznačně) reduced which is in virtue of less nociceptive afferentation. The antioedematous effect seems to be the result of an earlier angiogenesis, weak antiendothelial bounds with elevated permeability of proteins and erythrocytes into extracellular space are quickly replaced with adequate endothelial layer, due to the proliferation of endothelium. The healing process is completed with a remodeling of the scar, together with an anticipated reduction of hypertrophic scarring.

Conditions
Burns
Being tested
DE graft and PRP concentrate, DE graft
Keywords
Deep Burn Trauma, Dermo-Epidermal Graft, Platelet Rich Plasma Concentrate (PRP), Vancouver Scar Score, Scarring, Hypertrophic Scarring
Medical subject headings
Burns, Cicatrix, Cicatrix, Hypertrophic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DE graft and PRP concentrateProcedure or surgery

    Application of DE graft together with PRP concentrate

  • DE graftProcedure or surgery

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

Study groups in NCT01383187
Study groupRoleWhat they receive
DE graft and PRP concentrateExperimentalPatients enrolled in this arm receive the innovative treatment methods consisting of application of DE graft together with PRP concentrate.
Receives: Procedure: DE graft and PRP concentrate
Standard treatment groupActive comparatorPAtients included into this arm will receive a standard treatment for deep-burn injuries, i.e. DE graft without the application of the PRP concentrate.
Receives: Procedure: DE graft

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Healing assessed on Vancouver Scar Score

    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.

    Measured: 1st, 3rd, 6th month, 1 and 2 years after surgery

Secondary outcomes (4)
  1. Percentage of healing

    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.

    Measured: 4th, 6th, 8th, 10th, 12th, 14th, 16th, 18th day after surgery

  2. Vitality of the DE graft

    The vitality of the DE graft assessed on a scale enables us to measure the success of the healing process.

    Measured: 2nd, 4th, 6th, 8th, 10th and 14th post-operative day

  3. Epithelization of the DE graft

    The degree of epithelization assessed on a scale enables us to measure the success of the healing process.

    Measured: 2nd, 4th, 6th, 8th, 10th and 14th post-operative day

  4. Harvesting surface area

    The state of the harvesting degree area enables us to measure the success of the healing process.

    Measured: 2nd, 4th, 6th, 8th, 10th and 14th post-operative day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jun 2011 (estimated)
  2. Study startNov 2008
  3. Primary completionNov 2011
  4. Study completionDec 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01383187
Sponsor's protocol ID
99-OVZ-09-024
Status last verified
Mar 2013
First submitted
21 Jun 2011
Last updated
22 Mar 2013
Results posted
No
Data monitoring committee
Yes

Publications

  • Mehta S, Watson JT. Platelet rich concentrate: basic science and current clinical applications. J Orthop Trauma. 2008 Jul;22(6):432-8. doi: 10.1097/BOT.0b013e31817e793f.

    PubMed 18594311
  • Weibrich G, Kleis WK, Buch R, Hitzler WE, Hafner G. The Harvest Smart PRePTM system versus the Friadent-Schutze platelet-rich plasma kit. Clin Oral Implants Res. 2003 Apr;14(2):233-9. doi: 10.1034/j.1600-0501.2003.140215.x.

    PubMed 12656885
  • Landesberg R, Roy M, Glickman RS. Quantification of growth factor levels using a simplified method of platelet-rich plasma gel preparation. J Oral Maxillofac Surg. 2000 Mar;58(3):297-300; discussion 300-1. doi: 10.1016/s0278-2391(00)90058-2.

    PubMed 10716112
  • Marx RE. Platelet-rich plasma (PRP): what is PRP and what is not PRP? Implant Dent. 2001;10(4):225-8. doi: 10.1097/00008505-200110000-00002. No abstract available.

    PubMed 11813662
  • Mazzucco L, Medici D, Serra M, Panizza R, Rivara G, Orecchia S, Libener R, Cattana E, Levis A, Betta PG, Borzini P. The use of autologous platelet gel to treat difficult-to-heal wounds: a pilot study. Transfusion. 2004 Jul;44(7):1013-8. doi: 10.1111/j.1537-2995.2004.03366.x.

    PubMed 15225241
  • Prochazka V, Klosova H, Stetinsky J, Gumulec J, Vitkova K, Salounova D, Dvorackova J, Bielnikova H, Klement P, Levakova V, Ocelka T, Pavliska L, Kovanic P, Klement GL. Addition of platelet concentrate to dermo-epidermal skin graft in deep burn trauma reduces scarring and need for revision surgeries. Biomed Pap Med Fac Univ Palacky Olomouc Czech Repub. 2014 Jun;158(2):242-58. doi: 10.5507/bp.2013.070. Epub 2013 Sep 27.

    PubMed 24108222

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing DE graft and PRP concentrate and DE graft in people with Burns, run by University Hospital Ostrava at 1 site in Czechia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Healing assessed on Vancouver Scar Score (time frame: 1st, 3rd, 6th month, 1 and 2 years after surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01383187, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2013.

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