Elimination of Odor and Treatment of Malodorous Recalcitrant Wounds by Using Supraz and PRP-FG Versus Standard of Care
NCT ID: NCT05983302
Last Updated: 2024-03-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2/PHASE3
40 participants
INTERVENTIONAL
2023-08-20
2024-03-20
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
TRIPLE
Study Groups
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Platelet-Rich Plasma-Fibrin Glue
The first intervention group (group A) includes 10 patients with chronic wounds who, despite classic wound irrigation treatment, will be undergoing platelet-rich plasma-fibrin glue intervention for 8 weeks.
Platelet-Rich Plasma-Fibrin Glue
The first intervention group includes 10 patients with chronic wounds who, despite common treatment, will be undergone PRP-FG intervention for 8 weeks.
Repairing Gel
The second intervention group (group B) includes 10 patients with chronic wounds who, despite classic wound irrigation treatment, will be undergoing repairing gel intervention for 8 weeks. The components of repairing gel are vitamin A - vitamin C - vitamin B3 - glycine amino acid. - ethanol - collagen - citric acid - glycerin - malic acid - urea - carboxymethyl cellulose - Sodium alginate - Benzoic acid - Allantoin - Bromelain - Methylene blue - Violet dimethyl sulfoxide . The formulation is patented. (PCT, IR108458)
Repairing Gel
The second intervention group includes 10 patients with chronic wounds who, despite common treatment, will be undergone the repairing gel with approved wound healing components in the form of gel for 8 weeks.
Platelet-Rich Plasma-Fibrin Glue and Repairing Gel
The third intervention group (group C) includes 10 patients with chronic wounds who, despite classic wound irrigation treatment, will be undergoing the repairing gel with approved wound healing components and platelet-fibrin glue for 8 weeks.
Repairing Gel and Platelet-Rich Plasma-Fibrin Glue
The third intervention group includes 10 patients with chronic wounds who, despite common treatment, will be undergone the repairing gel with approved wound healing components in the form of gel and PRP-FG for 8 weeks.
Classical wound irrigation (control)
For 10 patients with chronic wounds, only classical wound irrigation by normal saline (0.9%) will be continued for 8 weeks.
Classical wound irrigation (control)
For 10 patients with chronic wounds, only the classical wound irrigation by normal saline will be continued for 8 weeks.
Interventions
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Platelet-Rich Plasma-Fibrin Glue
The first intervention group includes 10 patients with chronic wounds who, despite common treatment, will be undergone PRP-FG intervention for 8 weeks.
Repairing Gel
The second intervention group includes 10 patients with chronic wounds who, despite common treatment, will be undergone the repairing gel with approved wound healing components in the form of gel for 8 weeks.
Repairing Gel and Platelet-Rich Plasma-Fibrin Glue
The third intervention group includes 10 patients with chronic wounds who, despite common treatment, will be undergone the repairing gel with approved wound healing components in the form of gel and PRP-FG for 8 weeks.
Classical wound irrigation (control)
For 10 patients with chronic wounds, only the classical wound irrigation by normal saline will be continued for 8 weeks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Having a body mass index of 18-35
* Sign the informed consent by the patient
Exclusion Criteria
* Taking certain drugs that may interfere with wound healing, such as corticosteroids, immunosuppressive agents, and cytotoxic agents
ALL
No
Sponsors
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Aristotle University Of Thessaloniki
OTHER
Mashhad University of Medical Sciences
OTHER
Responsible Party
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Daryoush Hamidi Alamdari, PhD
Associate professor
Principal Investigators
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Daryoush Hamidi Alamdari, Ph.D
Role: PRINCIPAL_INVESTIGATOR
Surgical Oncology Research Center, Mashhad University of Medical Sciences, Mashhad, Iran.
George Koliakos, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Medical School, Aristotle University of Thessaloniki, Thessaloniki, Greece.
Locations
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Medical School, Aristotle University of Thessaloniki
Thessaloniki, , Greece
Mashhad University of Medical Sciences
Mashhad, Razavi Khorasan Province, Iran
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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IR.MUMS.REC.1402.089
Identifier Type: -
Identifier Source: org_study_id
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