- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03960164
Dermal Regeneration Photosynthetic Matrix (HULK)
Safety Use of Photosynthetic Dermal Scaffolds for the Treatment of Acute Wounds
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Safety of the dermal regeneration photosynthetic matrix (DRPM) will be conducted at: 1) Department of Plastic Surgery of Hospital del Salvador, 2) Red UC Christus, and/or 3) Instituto de Neurocirugía (INCA). This safety assessment represents the first objective of this trial, and will be performed in 20 human patients (between 18-65 years old) presenting non-infected acute wounds (confirmed by negative quantitative culture of tissue sample) and homogenous granulation bed. All patients involved in this study will participate only previous approval of the informed consent for the study protocol which has been already accepted by the Research Ethics Committee of the Metropolitan Health Service (approval number: CECSSMO080820018) and each of the affiliated hospitals.
The inclusion criteria of the patients consist of full-thickness skin wounds, homogeneous granulation tissue and negative bacterial count according to quantitative tissue culture. Exclusion criteria will be based on ages under 18 years or over 65 years. Also, patients with autoimmune diseases or immunosuppression will be excluded from the study. Patients with psychiatric disorders that impede decision-making and continue treatment will also be excluded from the treatment, as well as patients with injuries in the face.
Treatment will be performed in two surgical procedures. In the first one, DRPM will be implanted and illuminated with a LED array. Once the photosynthetic scaffold is properly adhered to the wound bed (approximately 21 days), a second surgical procedure will be carried out, where an autologous partial skin graft will be performed on top of the scaffold. In case of a major complication (uncontrollable pain, sepsis, shock), or at the request of the patient, the DRPM will be removed immediately and the standard treatment will be performed for that type of wound. All patients included in the study will be evaluated for local and systemic immune response against DRPM.
Systemic response will be studied by means of hematological, coagulation and biochemical profiles as well as by quantification of plasma cytokines and immune cells in peripheral blood. Hematological profiles will include hematocrit, erythrocytes, hemoglobin, platelets and leukocytes counts, performed by certified clinical laboratory methods. Coagulation tests will include international normalized ratio (INR), prothrombin time (PT) and partial thromboplastin time (PTT). Biochemical profiles will include quantification of blood glucose, creatinine, bilirubin direct and total levels, serum glutamic-oxaloacetic transaminase (SGOT), serum glutamic-pyruvic transaminase (SGPT), alkaline phosphatase and C-reactive protein, as well as clinically relevant enzymatic activities and plasmatic electrolytes (sodium, potassium and chloride). Concentration of inflammatory plasma cytokines (TNF-α, IL-1β, IL-6, IL-8, IL-12p70 and IL-10), as well as the following circulating immune cells: T-cells (CD3+), T-helper cells (CD3+CD4+), cytotoxic T-cells (CD3+CD8+) and their ratio (CD4+/CD8+), B-cells (CD19+) and NK cells (CD16+CD56+) will be quantified. All parameters will be quantified before DRPM implantation (day 0), short-term after implantation (1-3 days), 1 week after implantation and right before autograft procedure. Parameters will be also quantified short-term after autograft (1-3 days), 1 week after autograft and 2 months after autograft.
Additionally, in order to study the local response of DRPM implantation, a biopsy punch will be obtained before (day 0) and 1 week after scaffold implantation, as well as before and 1 week after autografting, and wound regeneration will be evaluated by quantification of cellularization (nuclear staining), presence of macrophages (CD68) and microorganisms (Giemsa) and neovascularization (CD31).
Finally, a final self-evaluation survey will be completed by all patients, where parameters such as pain, itching, burning, light annoyance, smell and general aspect of the wound will be evaluated.
Study Type
Enrollment (Actual)
Phase
- Early Phase 1
Contacts and Locations
Study Contact
- Name: Juan Camacho, Physician
- Phone Number: +56978786437
- Email: jpcamachomartino@gmail.com
Study Contact Backup
- Name: Miguel Obaid, Physician
- Phone Number: +56978528623
- Email: miguel.obaid.g@gmail.com
Study Locations
-
-
-
Santiago, Chile
- Instituto de Neurocirugía (INCA)
-
Santiago, Chile
- Red UC Christus
-
-
RM
-
Santiago, RM, Chile, 7500787
- Hospital del Salvador
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Device Feasibility
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Patient group
The group of patients included in the study following inclusion criteria with local (wound) and systemic test values prior and after to the application of the DRPM.
|
Primary Procedure: DRPM implantation
Secondary Procedure: Autologous partial skin graft |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Systemic response to the implanted scaffold
Time Frame: 3 months
|
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
|
Local response to the implanted scaffold
Time Frame: 4-5 weeks
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Wound closure
Time Frame: 4-5 weeks
|
Percentage of patients with complete wound closure.
|
4-5 weeks
|
Patient self-perception
Time Frame: Up to 10 days
|
Average percentage of satisfaction of the following parameters: pain, itch, burn, smell and light annoyance after DRPM implantation.
|
Up to 10 days
|
Collaborators and Investigators
Investigators
- Principal Investigator: Tomas Egaña, PhD., Pontificia Universidad Catolica de Chile
- Study Chair: Antonio Eblen-Zajjur, MD., PhD., Pontificia Universidad Catolica de Chile
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- SymbiOx
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Skin Wound
-
Central Finland Hospital DistrictUniversity of Eastern Finland; Tampere University HospitalActive, not recruitingWound Heal | Wound | Skin Wound | Skin Scarring | Wound of Skin | Wound Open | Wound BreakdownFinland
-
Brigham and Women's HospitalTerminatedSurgical Wound | Wound Heal | Wound of Skin | Full Thickness Skin Graft HealingUnited States
-
Molnlycke Health Care ABSyntactxCompletedAcute Wound | Skin Graft | Skin Flap | Traumatic Wound | Dehiscence | Subacute WoundBelgium, Italy, Germany, France
-
Brigham and Women's HospitalCompletedSurgical Wound | Wound Heal | Wound of Skin | Wound OpenUnited States
-
Brigham and Women's HospitalWithdrawnWound of Knee | Wound of Skin | Non-melanoma Skin Cancer | Skin Graft Complications | Wound of Lower LegUnited States
-
Wake Forest University Health SciencesCompleted
-
University of California, DavisEnrolling by invitationWound Heal | Wound of SkinUnited States
-
Children's Hospital of Orange CountyKitoTech Medical, Inc.RecruitingWound Heal | Laceration | Skin WoundUnited States
-
Stratatech, a Mallinckrodt CompanyBiomedical Advanced Research and Development AuthorityActive, not recruitingBurns | Skin Wound | Trauma-related WoundUnited States
-
Stratatech, a Mallinckrodt CompanyCompletedBurns | Skin Wound | Trauma-related WoundUnited States
Clinical Trials on Dermal regeneration photosynthetic matrix (DRPM)
-
Nanfang Hospital of Southern Medical UniversityCompleted
-
Georgetown UniversityIntegra LifeSciences CorporationUnknown
-
University of UtahCompletedBreast Cancer | Reconstructive SurgeryUnited States
-
Istituto Ortopedico RizzoliRecruiting
-
Aarhus University HospitalCompletedSurgiMend® vs. Strattice™ in Direct to Implant Breast Reconstruction- A Prospective Randomized TrialBreast NeoplasmsDenmark
-
Faculty of Dental Medicine for GirlsCompletedComparative StudyEgypt
-
Musculoskeletal Transplant FoundationWashington University School of Medicine; Pines Surgical; Meridian Healthcare...CompletedHernia of Abdominal WallUnited States
-
University of LouisvilleCompleted
-
Integra LifeSciences CorporationCompletedNeuropathic Diabetic Ulcer - FootUnited States, Netherlands Antilles
-
West China HospitalCompleted