Clinical trial
Safety Use of Photosynthetic Dermal Scaffolds for the Treatment of Acute Wounds
Name
SymbiOx
Description
The aim of the study is to demonstrate that dermal regeneration photosynthetic matrix applied in patients with acute clean skin wound is safe.
Trial arms
Trial start
2019-04-01
Estimated PCD
2023-06-30
Trial end
2023-11-01
Status
Completed
Phase
Early phase I
Treatment
Dermal regeneration photosynthetic matrix (DRPM)
Primary Procedure: DRPM implantation
1. Wound bed preparation and cleaning.
2. DRPM implantation.
3. Illumination with LED device.
Secondary Procedure: Autologous partial skin graft
Arms:
Patient group
Size
20
Primary endpoint
Systemic response to the implanted scaffold
3 months
Local response to the implanted scaffold
4-5 weeks
Eligibility criteria
Inclusion Criteria:
* Full-thickness skin wounds.
* Between 18 and 65 years old
* Non-infected wounds (confirmed by quantitative culture of the tissue sample).
* Homogeneous granulation of wound bed.
* Approval of the informed consent for the study protocol.
Exclusion Criteria:
* Ages under 18 years or older than 65 years.
* Comorbidities such as autoimmune diseases, immunosuppression, coronary heart disease or occlusive arterial disease.
* Chronic drug and/or alcohol abuse.
* Psychiatric disorders that impede decision-making and continue treatment.
* Patients suffering from an acute pathology other than the skin injury.
* Full-thickness skin wounds in face.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['EARLY_PHASE1'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Single group to test safety of the treatment', 'primaryPurpose': 'DEVICE_FEASIBILITY', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'There will be no masking of the treatment for researchers'}}, 'enrollmentInfo': {'count': 20, 'type': 'ACTUAL'}}
Updated at
2023-11-21
1 organization
1 product
1 indication
Organization
Pontificia Universidad Catolica de ChileIndication
Wound