NCT01383187

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Nov 2008

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2008

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

June 21, 2011

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 28, 2011

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

March 22, 2013

Status Verified

March 1, 2013

Enrollment Period

3 years

First QC Date

June 21, 2011

Last Update Submit

March 21, 2013

Conditions

Burns

Keywords

Deep Burn TraumaDermo-Epidermal GraftPlatelet Rich Plasma Concentrate (PRP)Vancouver Scar ScoreScarringHypertrophic Scarring

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (4)

  • Percentage of healing

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

  • Vitality of the DE graft

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

  • Epithelization of the DE graft

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

  • Harvesting surface area

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

Study Arms (2)

DE graft and PRP concentrate

EXPERIMENTAL

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

Standard treatment group

ACTIVE COMPARATOR

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

Interventions

DE graft and PRP concentratePROCEDURE

Application of DE graft together with PRP concentrate

DE graft and PRP concentrate
DE graftPROCEDURE

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

Standard treatment group

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Ostrava

Ostrava-Poruba, Czech Republic, 708 52, Czechia

Location

Related Publications (6)

  • 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.

    PMID: 18594311BACKGROUND

  • 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.

    PMID: 12656885BACKGROUND

  • 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.

    PMID: 10716112BACKGROUND

  • 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.

    PMID: 11813662BACKGROUND

  • 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.

    PMID: 15225241BACKGROUND

  • 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.

    PMID: 24108222DERIVED

MeSH Terms

Conditions

BurnsCicatrixCicatrix, Hypertrophic

Condition Hierarchy (Ancestors)

Wounds and InjuriesFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Hana Klosova, MD

    University Hospital Ostrava

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 21, 2011

First Posted

June 28, 2011

Study Start

November 1, 2008

Primary Completion

November 1, 2011

Study Completion

December 1, 2011

Last Updated

March 22, 2013

Record last verified: 2013-03

Locations

CZ(1)