Study on the healing of the partial skin graft donor site in burn patients after application of platelet-rich plasma (PRP) or plasma rich in growth factors versus usual therapeutical practice.

INSTITUTO DE INVESTIGACION SANITARIA LA FE0 个研究点目标入组 34 人开始时间: 2016年4月18日最近更新: 2018年11月6日

试验速览

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•1.Male or female aged between 18 and 70 years old at the time of consent
•2. Subjects able to understand the informed consent form provided and who have signed voluntarily (no subject should be forced to participate in the trial), by themselves or through their family guardians or, if necessary, legal representatives
•3. Subjects willing to meet all the trial requirements. They must be willing to visit the site on the dates identified in the study for the cures and the collection of photographic documentation until complete regeneration of the wound. Subjects must agree to make a follow-up visit at 1st month, 3rd, 6th and 12th months
•4. Subjects with second or third degree burn likely to receive skin autografts with a minimum size of 112,5cm2
•5. Subjects who develop a skin burn injury affecting a partial thickness between 0.5% and maximum 10% of the body surface
•6. Patients with serology compatible with pathology
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 20
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 14

•1.Subjects who have a skin burn injury affecting more than the 10% of the body surface
•2. Pregnant or breast-feeding
•3. Diseases or conditions that, in the investigator's opinion, could interfere with the assessment of safety or efficiency
•4. Patients who have a chronic skin disease or currently active that the investigator considers could adversely affect the skin regeneration
•5. Subjects with medical background of coagulopathy
•6. Subjects with chronic treatment of corticosteroids or other immunosuppressive drugs
•7. Immunosuppressed subjects
•8. Subjects affected by any acute infectious disease
•9. Subjects affected by any systemic disease that can worsen the prognosis if any adverse effects occurs (patients with poorly controlled diabetes presenting retinopathy or peripheral vascular disease, severe hypertension or severe disease). Decompensation of diabetes linked to stress-induced injury or surgery is not considered exclusion criteria
•10. Subjects who are part of the research team: researchers, collaborators, nurses, workers in the center or any other person directly related to the protocol development 11. Subjects with mental incapacity or language barriers that impede proper understanding of the informed consent form or cooperation or predisposition necessary to comply with the trial procedures

发起方

INSTITUTO DE INVESTIGACION SANITARIA LA FE