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โ† Trials
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Efficacy of a Photosynthetic Dermal Matrix for the Treatment of Full-Thickness Skin Wounds

RecruitingPhase 2Ages 18 Years - anyAllPontificia Universidad Catolica de Chile
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In plain words

What the trial is, and whether it could suit you

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 r

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๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: 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 cmยฒ and 200 cmยฒ. * Signed informed consent to participate in the study. Exclusion Criteria: * 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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What it tests

  • Surgical implantation with standard (DRM) or photosynthetic dermal regeneration matrices (PDRM) in same patient.
  • Autologous split-thickness skin grafting over implanted matrices
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Where

1 site
Hospital del Trabajador
Santiago, Chile
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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