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Efficacy of a Photosynthetic Dermal Matrix for the Treatment of Full-Thickness Skin Wounds
Sponsor: Pontificia Universidad Catolica de Chile
Summary
The goal of this clinical trial is to evaluate whether the incorporation of photosynthetic microalgae into scaffolds for dermal regeneration improves healing outcomes in adult patients with acute and cronic full-thickness skin wounds. The primary objectives are to determine whether the use of photosynthetic scaffolds enhances wound granulation and reduces infection rates compared to standard dermal regeneration scaffolds. Additionally, the quality of the regenerated skin will be assessed and compared between treatment types. Participants will: * Receive treatment with either standard dermal regeneration scaffolds or identical scaffolds containing photosynthetic microalgae. These treatments will be applied either to randomly assigned areas of the same wound or to different wounds on the same patient. * Undergo regular follow-up assessments to monitor wound healing progress, infection rates, graft integration, and the qualiy of the regenerated skin. * Complete self-assessment questionnaires regarding their experience and perceived outcomes.
Official title: Evaluation of the Efficacy of a Dermal Regeneration Matrix With Photosynthetic Microalgae for the Treatment of Patients With Full-Thickness Skin Wounds: Phase 2 Study
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
20
Start Date
2025-06-24
Completion Date
2028-05
Last Updated
2025-09-05
Healthy Volunteers
Yes
Interventions
Surgical implantation with standard (DRM) or photosynthetic dermal regeneration matrices (PDRM) in same patient.
Under sterile conditions and appropriate anesthesia, standard dermal regeneration matrices (DRMs) and photosynthetic dermal regeneration matrices (PDRMs), containing live photosynthetic microalgae, are implanted in separate wound areas or in anatomically distinct wounds on the same patient. Each site is then covered with a transparent adhesive dressing. In the experimental (PDRM) area, a light-emitting dressing is applied to stimulate photosynthesis and promote localized oxygen production.
Autologous split-thickness skin grafting over implanted matrices
Approximately 21 days after the initial intervention, and once the wound bed meets predefined grafting criteria based on clinical evaluation, an autologous dermo-epidermal skin graft is performed.
Locations (1)
Hospital del Trabajador
Santiago, RM, Chile