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
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Wound granulation rate
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Treatment with standard or photosynthetic dermal regeneration matrices in same patient.
Surgical implantation of dermal regeneration matrices:
Primary procedure: Participants will receive both a standard dermal regeneration matrix (DRM; control) and a photosynthetic dermal regeneration matrix (PDRM; experimental), which is seeded with Chlamydomonas reinhardtii microalgae. The two matrices will be implanted into randomized areas of the same full-thickness wound or into separate full-thickness wounds on the same patient. A light-emitting dressing will be placed over the wound area to activate photosynthesis in the PDRM, facilitating localized oxygen production.
Secondary procedure: Approximately 21 days after matrix implantation, once sufficient granulation tissue has formed, an autologous split-thickness skin graft will be applied to the wound areas.
干预措施: Surgical implantation with standard (DRM) or photosynthetic dermal regeneration matrices (PDRM) in same patient. (Biological)
Treatment with standard or photosynthetic dermal regeneration matrices in same patient.
Surgical implantation of dermal regeneration matrices:
Primary procedure: Participants will receive both a standard dermal regeneration matrix (DRM; control) and a photosynthetic dermal regeneration matrix (PDRM; experimental), which is seeded with Chlamydomonas reinhardtii microalgae. The two matrices will be implanted into randomized areas of the same full-thickness wound or into separate full-thickness wounds on the same patient. A light-emitting dressing will be placed over the wound area to activate photosynthesis in the PDRM, facilitating localized oxygen production.
Secondary procedure: Approximately 21 days after matrix implantation, once sufficient granulation tissue has formed, an autologous split-thickness skin graft will be applied to the wound areas.
干预措施: Autologous split-thickness skin grafting over implanted matrices (Procedure)
结局指标
主要结局
Wound granulation rate
时间窗: From first intervention (Day 0) to readiness of granulation bed for autologus split-thickness sking grafting (up to 21 days).
Time to wound bed readiness for autologous split-thickness skin grafting, measured in days from the implantation of the dermal regeneration matrix (with or without microalgae) to the clinical determination of over 95% of granulation tissue. Wound bed readiness will be assessed using a standardized Clinical Follow-Up Form by at least two independent medical evaluators. Readiness is defined as the presence of well-vascularized, homogeneous granulation tissue deemed suitable for graft acceptance. Based on manufacturer data, the expected time to graft readiness in the control (DRM) group is approximately 21 days post-implantation. The microalgae-containing matrix (PDRM) is hypothesized to reduce this time due local oxygen production.
次要结局
- Incidence of wound Infections(From first intervention (Day 0) to readiness of granulation bed for autologus split-thickness sking grafting (up to 21 days).)
- Patient-Reported Impact(From first intervention (Day 0) to readiness of granulation bed for autologus split-thickness sking grafting (up to 21 days).)
- Autologous graft performance(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(3 months after first intervention (Day 0).)
- Long-Term Skin Appearance(3 months after first intervention (Day 0).)
研究者
Jose Tomas Egaña
Associate Professor
Pontificia Universidad Catolica de Chile