Dermal Regeneration Photosynthetic Matrix

Safety of the dermal regeneration photosynthetic matrix (DRPM) will be conducted at the Departament of Plastic Surgery at Hospital del Salvador. This safety assessment represents the objetive 1 of this trial, and will be performed in 20 human patients (between 18-65 years old) without comorbidities, presenting non-infected acute wounds (confirmed by negative quantitative culture of tissue sample) and homogenous granulation bed. All patients involved in this study, will participate only previous approval of the informed consent for the study protocol which has been already accepted by the Ethical committee of the Hospital del Salvador.

The inclusion criterion of the patients consists of full-thickness skin wounds, homogeneous granulation tissue and negative bacterial count according to quantitative tissue culture. Exclusion criteria will be based on ages under 18 years or over 65 years. Also, the presence of comorbidities such as hypertension, diabetes mellitus, chronic liver damage, autoimmune diseases, neoplasia, immunosuppression, coronary heart disease, occlusive arterial disease, chronic smoking, drug abuse and/or alcohol. Patients with psychiatric disorders that impede decision-making and continue treatment will also be excluded from the treatment, as well as patients suffering from an acute pathology other than the injury or patients with injuries in the face face and neck.

In case of a major complication (uncontrollable pain, sepsis, shock), or at the request of the patient, the DRPM will be removed immediately and the standard treatment will be performed for that type of wound. All patients included in the study will be evaluated for the immune response against DRPM by means of blood count, C-reactive protein (CRP), renal and hepatic profiles, concentration of inflammatory molecules (IL-6, IL-10, MCP-1, IFN-gamma and TNF-alpha), as well as the following circulating immune cells: T lymphocytes (CD25, CD69, CD62L, CD4 and CD8), B lymphocytes (CD27, CD69, CD19 and CD20), NK1.1 cells (CD14) and CD45 RA and CD45-RO cells, at 0, 3 and 6 days after the patient admission and at 3, 17, 20, 23, 36, 90 and 180 days after DRPM implantation.

Additionally, a biopsy punch will be obtained at days 2 and 5 after DRPM implantation, and wound regeneration will be evaluated by quantification of quantification of cellularization (nuclear staining), vacularization (CD31), cell proliferation (Ki67), hypoxia and extracellular matrix deposition (fibronectin and collagen-1). A final survey about the obtained results will be made to all patients.