Study on healing the graft donor skin on burn patients
Conditions
Interventions
Product Name: Platelet-rich plasma (PRP)
Pharmaceutical Form: Cutaneous liquid
INN or Proposed INN: Platelet-rich plasma (PRP)
Other descriptive name: PLATELETS, HUMAN BLOOD
Concentration unit: ml mil
Sponsors
INSTITUTO DE INVESTIGACION SANITARIA LA FE
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Study on healing the graft donor site of partial skin in burn patients after application of platelet-rich plasma or plasma rich in growth factors versus routine therapy;Secondary Objective: 1. Determine if there are significant differences in the perception of pain by the patient among the products evaluated 2. Determine if there are significant differences in the rate of infection after application of the products tested, from the collection of adverse events 3. Determine if there are significant differences in the therapeutic potential of the two products assessed (PRP and PRGF) 4. Develop a protocol for the collection and clinical use, either PRP or PRGF for the treatment of donor sites 5. Define the parameters to be evaluated when implement protocols for obtaining PRGF PRP or therapeutic purposes 6. Design a risk management system specific for this type of activity 7. Determine the cost of the proposed model and its comparison with other methodologies for the type of products evaluated in this project or with other therapeutic approaches 8. Establish the base for possible future expansion of the methodology applied to the field of major burns;Primary end point(s): - Total healing time, objectified by the observer. The unit of measurement used will be days.;Timepoint(s) of evaluation of this end point: Days 3, 5, 8, 11, 14, 17, 20, 23, 26, 29; Months 1, 3, 6 and 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Pain objectified by the patient during handling of the donor skin area in subsequent follow-up visits until complete epithelialization - Rate of infection of different therapeutic options used - Quality of healing: - Measure the elasticity of the skin - Scale Vancouver. - Scale for the assessment of the scar by patient and observer - Quantification of the health economic expense of the treatment with these products compared to other therapeutic alternatives - Haematological blood variables for the production of PRP and PRGF - Concentration of growth factors PDGF, TGF-B, EGF and VEGF of the supernatant PRP coagulated and PRGF - Determination of platelet activation during plasma processing.;Timepoint(s) of evaluation of this end point: Days 3, 5, 8, 11, 14, 17, 20, 23, 26, 29; Months 1, 3, 6 and 12 | — |
Countries
Spain
Contacts
Public ContactUREC
INSTITUTO DE INVESTIGACION SANITARIA LA FE
Outcome results
None listed