Dermal Regeneration Photosynthetic Matrix
Condition: Skin Wound
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The aim of the study is to demonstrate that dermal regeneration photosynthetic matrix applied
      in patients with acute clean skin wound is safe.
    

Detailed description: 
      Safety of the dermal regeneration photosynthetic matrix (DRPM) will be conducted at: 1)
      Department of Plastic Surgery of Hospital del Salvador, 2) Red UC Christus, and/or 3)
      Instituto de Neurocirugía (INCA). This safety assessment represents the first objective of
      this trial, and will be performed in 20 human patients (between 18-65 years old) 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 Research Ethics Committee of the Metropolitan Health Service (approval
      number: CECSSMO080820018) and each of the affiliated hospitals.

      The inclusion criteria of the patients consist 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, patients with
      autoimmune diseases or immunosuppression will be excluded from the study. Patients with
      psychiatric disorders that impede decision-making and continue treatment will also be
      excluded from the treatment, as well as patients with injuries in the face.

      Treatment will be performed in two surgical procedures. In the first one, DRPM will be
      implanted and illuminated with a LED array. Once the photosynthetic scaffold is properly
      adhered to the wound bed (approximately 21 days), a second surgical procedure will be carried
      out, where an autologous partial skin graft will be performed on top of the scaffold. 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 local and
      systemic immune response against DRPM.

      Systemic response will be studied by means of hematological, coagulation and biochemical
      profiles as well as by quantification of plasma cytokines and immune cells in peripheral
      blood. Hematological profiles will include hematocrit, erythrocytes, hemoglobin, platelets
      and leukocytes counts, performed by certified clinical laboratory methods. Coagulation tests
      will include international normalized ratio (INR), prothrombin time (PT) and partial
      thromboplastin time (PTT). Biochemical profiles will include quantification of blood glucose,
      creatinine, bilirubin direct and total levels, serum glutamic-oxaloacetic transaminase
      (SGOT), serum glutamic-pyruvic transaminase (SGPT), alkaline phosphatase and C-reactive
      protein, as well as clinically relevant enzymatic activities and plasmatic electrolytes
      (sodium, potassium and chloride). Concentration of inflammatory plasma cytokines (TNF-α,
      IL-1β, IL-6, IL-8, IL-12p70 and IL-10), as well as the following circulating immune cells:
      T-cells (CD3+), T-helper cells (CD3+CD4+), cytotoxic T-cells (CD3+CD8+) and their ratio
      (CD4+/CD8+), B-cells (CD19+) and NK cells (CD16+CD56+) will be quantified. All parameters
      will be quantified before DRPM implantation (day 0), short-term after implantation (1-3
      days), 1 week after implantation and right before autograft procedure. Parameters will be
      also quantified short-term after autograft (1-3 days), 1 week after autograft and 2 months
      after autograft.

      Additionally, in order to study the local response of DRPM implantation, a biopsy punch will
      be obtained before (day 0) and 1 week after scaffold implantation, as well as before and 1
      week after autografting, and wound regeneration will be evaluated by quantification of
      cellularization (nuclear staining), presence of macrophages (CD68) and microorganisms
      (Giemsa) and neovascularization (CD31).

      Finally, a final self-evaluation survey will be completed by all patients, where parameters
      such as pain, itching, burning, light annoyance, smell and general aspect of the wound will
      be evaluated.
    

Intervention name(s): Dermal regeneration photosynthetic matrix (DRPM)
Intervention type(s): Combination Product
Intervention description(s): Primary Procedure: DRPM implantation
Wound bed preparation and cleaning.
DRPM implantation.
Illumination with LED device.
Secondary Procedure: Autologous partial skin graft
Intervention model: Single Group Assignment
Intervention model description: Single group to test safety of the treatment
Masking: None (Open Label)
Primary purpose: Device Feasibility
Keywords: Acute skin lesion; Chronic skin ulcer; Traumatic skin lesion; Photosynthetic matrix; Photosynthesis induced regeneration; Tissue regeneration