Efficacy of a Photosynthetic Dermal Matrix for the Treatment of Full-Thickness Skin Wounds
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorPontificia Universidad Catolica de Chile
About this trial
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
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Surgical implantation with standard (DRM) or photosynthetic dermal regeneration matrices (PDRM) in same patient.
Biological/VaccineUnder 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.
Autologous split-thickness skin grafting over implanted matrices
Procedure/SurgeryApproximately 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.
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: Treatment with standard or photosynthetic dermal regeneration matrices in same patient.Experimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Wound granulation rate
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.
Time frame
From first intervention (Day 0) to readiness of granulation bed for autologus split-thickness sking grafting (up to 21 days).Secondary outcomes
1
Incidence of wound Infections
The incidence amongst the treated individuals of clinically diagnosed wound infections in areas treated with standard dermal regeneration matrices (DRM) or photosynthetic dermal regeneration matrices (PDRM) will be assessed and compared. Diagnosis will be based on predefined clinical criteria, including signs of erythema, purulent exudate, increased local temperature, and pain, as evaluated by the clinical team.
Time frame
From first intervention (Day 0) to readiness of granulation bed for autologus split-thickness sking grafting (up to 21 days).2
Patient-Reported Impact
The subjective impact on patients, following treatment with dermal regeneration matrices with or without microalgae (DRM or PDRM) will be assessed using a self-evaluation questionnaire. Five parameters will be assessed (pain, itch, burning, smell, light annoyance), to give a total overall satisfaction percentage related to the presence of the treatment, with percentages closer to 0% indicating less discomfort and more satisfaction.
Time frame
From first intervention (Day 0) to readiness of granulation bed for autologus split-thickness sking grafting (up to 21 days).3
Autologous graft performance
The performance of autologous dermo-epidermal grafts placed over control (DRM) or photosynthetic dermal regeneration matrice (PDRM), will be assessed through clinical evaluation. The area of adequate adherence of the autologous dermo-epidermal graft, relative to the initial area of the graft, will be measured. Aditionally, supplementary laboratory tests will be performed, to evaluate the overall health of the patient.
Time frame
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).4
Long-Term Skin Functionality
Functional outcomes of the regenerated skin will be assessed through mechanical skin measurements using a Cutometer instrument, to determine and compare the elasticity in areas treated with the different matrices, relative to adjacent healthy skin areas. Skin deformation curves (in mm/sec) will be obtained, and several elasticity parámeter will be calculated and compared between treatments.
Time frame
3 months after first intervention (Day 0).Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Pontificia Universidad Catolica de Chile
Lead sponsor
Hospital del Trabajador de Santiago
Collaborator
SymbiOx Inc.
Collaborator
Source ClinicalTrials.gov