RecruitingPhase 2NCT07157657

Efficacy of a Photosynthetic Dermal Matrix for the Treatment of Full-Thickness Skin Wounds

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


Sponsor

Pontificia Universidad Catolica de Chile

Enrollment

20 participants

Start Date

Jun 24, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria5

  • Patients covered by social insurance law or under the "Complementary Service Sales" (VSC) program, aged 18 years or older.
  • Presence of full-thickness skin wounds.
  • Wounds with homogeneous granulation tissue.
  • Wound size between 25 cm² and 200 cm².
  • Signed informed consent to participate in the study.

Exclusion Criteria4

  • History of a psychiatric disorder that may impair decision-making or adherence to treatment.
  • Presence of an acute medical condition unrelated to the wound at the time of enrollment.
  • Wound with exposed bone, tendon, or major blood vessels.
  • Psychosocial conditions that may hinder adherence to the study protocol.

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Interventions

BIOLOGICALSurgical 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.

PROCEDUREAutologous 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

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NCT07157657