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Recruiting Phase 2 NCT07157657

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

Trial Parameters

Condition Cronic Full-thinkness Skin Wound
Sponsor Pontificia Universidad Catolica de Chile
Study Type INTERVENTIONAL
Phase Phase 2
Enrollment 20
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2025-06-24
Completion 2028-05
Interventions
Surgical implantation with standard (DRM) or photosynthetic dermal regeneration matrices (PDRM) in same patient.Autologous split-thickness skin grafting over implanted matrices

Brief 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 Criteria

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 cm² and 200 cm². * 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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