Study on healing of the healthy skin area where the skin of the burn patients is taken to cure the burned area, after application of autologous products (obtained from the patient): The platelet-rich plasma (PRP) and plasma rich in growth factors (PRGF), compared with commonly used therapy

Phase 1

• Conditions: Study on healing the graft donor skin on burn patients; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2016-000968-42-ES
• Lead Sponsor: INSTITUTO DE INVESTIGACION SANITARIA LA FE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-04-18
• Last Update Posted: 6 November 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 34

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified