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

NCT07157657 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2025-09-05

No results posted yet for this study

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.

Conditions

  • Cronic Full-thinkness Skin Wound
  • Acute Full-thickness Skin Wound

Interventions

BIOLOGICAL

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.

PROCEDURE

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.

Sponsors & Collaborators

  • Hospital del Trabajador de Santiago

    collaborator OTHER

  • SymbiOx Inc.

    collaborator UNKNOWN

  • Pontificia Universidad Catolica de Chile

    lead OTHER

Principal Investigators

  • José Tomás Egaña, PhD · Pontificia Universidad Catolica de Chile

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-06-24
Primary Completion
2028-05-31
Completion
2028-05-31

Countries

  • Chile

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07157657 on ClinicalTrials.gov