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

Официальное название

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

Обзор

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.

Подробное описание

Chronic and acute skin wounds are a significant and growing public health concern, affecting millions of people worldwide and placing a substantial burden on healthcare systems. These wounds, often resulting from underlying conditions such as diabetes, vascular disease, or trauma, can take months or even years to heal, severely impacting patients' quality of life. As global populations age and chronic diseases become more prevalent, the need for more effective wound care solutions is becoming increasingly urgent.

One area of innovation in wound management involves the use of advanced biomaterials that support the body's natural regenerative processes. Dermal regeneration matrices (DRMs) are among the most promising of these technologies, providing a structural scaffold to facilitate tissue repair. However, a major limitation of current DRMs is the poor oxygenation at the wound site during the initial phases of healing-an issue that can delay granulation tissue formation, increase infection risk, and ultimately impair outcomes.

To address this challenge, a novel approach has been developed that incorporates photosynthetic microalgae into the scaffold itself. These microorganisms are capable of producing oxygen when exposed to light, offering a potential means of delivering localized oxygen directly to the wound bed. This photosynthetic dermal regeneration matrix (PDRM) is designed to create a more favorable microenvironment for tissue regeneration by enhancing local oxygen availability in situ.

The present study is a randomized, controlled clinical trial designed to evaluate the safety and efficacy of PDRMs in adult patients with acute and cronic full-thickness skin wounds. Outcomes in wounds treated with PDRMs will be compared to those treated with conventional DRMs. Key endpoints include wound closure, granulation tissue formation, infection rates, graft integration, and overall skin regeneration quality.

If effective, this approach could represent a significant advance in wound care, offering accelerated healing, reduced complications, and improved patient-reported outcomes. The strategy may also broaden the applicability of regenerative therapies in diverse clinical settings by enhancing the functionality of existing biomaterials.

Вмешательства

• Биопрепарат 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.
• Процедура 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.

Первичные конечные точки

• Wound granulation rate [Срок оценки: From first intervention (Day 0) to readiness of granulation bed for autologus split-thickness sking grafting (up to 21 days).]

Вторичные конечные точки (5)

• Incidence of wound Infections [Срок оценки: From first intervention (Day 0) to readiness of granulation bed for autologus split-thickness sking grafting (up to 21 days).]
• Patient-Reported Impact [Срок оценки: From first intervention (Day 0) to readiness of granulation bed for autologus split-thickness sking grafting (up to 21 days).]
• Autologous graft performance [Срок оценки: Following autologous graft implantation (Day 21), patients are monitored periodically for up to 3 months from the date of the original matrix implantation (Day 0).]
• Long-Term Skin Functionality [Срок оценки: 3 months after first intervention (Day 0).]
• Long-Term Skin Appearance [Срок оценки: 3 months after first intervention (Day 0).]

Критерии участия

Критерии включения

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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Чили · 1 центр

• Hospital del Trabajador — Santiago

Идентификаторы

NCT: NCT07157657 · CEC/21/2024 · 24IAT-272741

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗