Skin Wound Clinical Trial
— HULKOfficial title:
Safety Use of Photosynthetic Dermal Scaffolds for the Treatment of Acute Wounds
Verified date | July 2022 |
Source | Pontificia Universidad Catolica de Chile |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The aim of the study is to demonstrate that dermal regeneration photosynthetic matrix applied in patients with acute clean skin wound is safe.
Status | Completed |
Enrollment | 20 |
Est. completion date | November 1, 2023 |
Est. primary completion date | June 30, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Chile | Hospital del Salvador | Santiago | RM |
Chile | Instituto de Neurocirugía (INCA) | Santiago | |
Chile | Red UC Christus | Santiago |
Lead Sponsor | Collaborator |
---|---|
Pontificia Universidad Catolica de Chile | Hospital del Salvador, SymbiOx Inc. |
Chile,
Obaid ML, Camacho JP, Brenet M, Corrales-Orovio R, Carvajal F, Martorell X, Werner C, Simon V, Varas J, Calderon W, Guzman CD, Bono MR, San Martin S, Eblen-Zajjur A, Egana JT. A First in Human Trial Implanting Microalgae Shows Safety of Photosynthetic The — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Systemic response to the implanted scaffold | Percentage of patients presenting adverse effects, measured by hematological, coagulation and biochemical profiles as well as concentration of plasma cytokines and immune cells in peripheral blood. | 3 months | |
Primary | Local response to the implanted scaffold | Percentage of patients presenting adverse effects, measured by: abnormal levels of macrophages, microorganisms in the implanted site and/or non-adherence of the scaffold to the wound bed. | 4-5 weeks | |
Secondary | Wound closure | Percentage of patients with complete wound closure. | 4-5 weeks | |
Secondary | Patient self-perception | Average percentage of satisfaction of the following parameters: pain, itch, burn, smell and light annoyance after DRPM implantation. | Up to 10 days |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT03947450 -
Autologous Volar Fibroblast Injection Into the Stump Site of Amputees
|
Phase 2 | |
Completed |
NCT01437852 -
StrataGraft® Skin Tissue as an Alternative to Autografting Deep Partial-Thickness Burns
|
Phase 1 | |
Active, not recruiting |
NCT03649308 -
Negative Pressure Wound Therapy Compared to Traditional Care After Skin Grafting
|
N/A | |
Recruiting |
NCT05984628 -
Umbilical Cord Stem Cells for Skin Grafts in Donor Site Wounds
|
N/A | |
Completed |
NCT05112679 -
Limb Health and Socket Pressure in Response to Powered Ankle Protheses
|
N/A | |
Completed |
NCT03795116 -
Light Emitting Diode-Red Light (LED-RL) Phototherapy for Skin Scarring Prevention
|
Phase 2 | |
Recruiting |
NCT04557761 -
Comparison of microMend® Devices to Sutures in Closing Lacerations in Children
|
N/A | |
Active, not recruiting |
NCT03394612 -
Study With an Autologous Dermo-epidermal Skin Substitute for the Treatment of Full-Thickness Skin Defects in Adults and Children
|
Phase 2 | |
Withdrawn |
NCT05643755 -
Preoperative Image-based Education Effect on Postoperative Satisfaction of Patients Undergoing First-time Dermatologic Surgery
|
N/A | |
Completed |
NCT03754218 -
Amnion Wound Covering for Enhanced Wound Healing
|
Early Phase 1 | |
Active, not recruiting |
NCT05517902 -
StrataGraft Safety, Tolerability and Efficacy in Pediatric Subjects
|
Phase 3 | |
Terminated |
NCT03005054 -
StrataGraft® Skin Tissue as an Alternative to Autografting Full-thickness Complex Skin Defects
|
Phase 2 | |
Completed |
NCT06352853 -
Scalpel Versus Diathermy in Transverse Abdominal Skin Incision During Cesarean Section
|
N/A |