Clinical trial NCT05983302: Elimination of Odor and Treatment of Malodorous Recalcitrant Wounds by Using Supraz and PRP-FG Versus Standard of Care
Official title: Repairing Gel (Supraz) and Platelet-rich Plasma-Fibrin Glue (PRP-FG) in Eliminating Odor and Healing the Malodorous Chronic Wounds Versus Standard of Care
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
PHASE3
Conditions: Wounds and Injuries
Keywords: Platelet-Rich Plasma-Fibrin Glue
Repairing Gel
Chronic Wounds
Malodorous
Recalcitrant
Lead sponsor: Mashhad University of Medical Sciences
Sponsor class: OTHER
Collaborators: name: Aristotle University Of Thessaloniki
First posted: 2023-08-09
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to eliminate the malodorous of chronic wound and increase the chance of the healing of recalcitrant wounds by using the repairing gel (supraz gel) which has the approved components in wound healing and platelet-rich plasma-fibrin glue.

Detailed description: The current study assesses the effects of platelet-rich plasma-fibrin glue (PRP-FG) along with the use of the repairing gel which has the approved components on wound healing in patients with chronic wounds and to eliminate the malodorous of chronic wound. This randomized controlled trial is performed on patients with chronic wounds. Patients will be treated with repairing gel (supraz gel) plus PRP-FG dressing (intervention group) or only Supraz gel (intervention group) or only PRP-FG dressing (intervention group) every 48 hours for 8 weeks versus standard of care of treatment (control group: irrigation of wound by normal saline 0.9%).

Eligibility criteria: Inclusion Criteria:

* Having a single wound on the body that has been at least 3 months old and has not been repaired by wound irrigation with normal saline and changing the dressing
* Having a body mass index of 18-35
* Sign the informed consent by the patient

Exclusion Criteria:

* Having concurrent diseases that may cause problems in wound healing, such as cancers, vasculitis, kidney and liver failure, and heart failure
* Taking certain drugs that may interfere with wound healing, such as corticosteroids, immunosuppressive agents, and cytotoxic agents

Primary outcomes:
measure: Wound Odor Change
timeFrame: At the beginning of the study (0 day) and at the end of the eighth week of the intervention (8 weeks)
measure: Wound Size Change
timeFrame: At the beginning of the study (0 day) and at the end of the eighth week of the intervention (8 weeks)
measure: Visual Analog Scale changes for pain assessment
timeFrame: Every 48 hours for 8 weeks
measure: Duration of recovery
timeFrame: 8 weeks
measure: Change in the systemic inflammatory marker C-reactive protein (CRP)
timeFrame: At the beginning of the study (0 day) and at the end of the eighth week of the intervention (8 weeks)
measure: Change in systemic inflammatory marker erythrocyte sedimentation rate (ESR)
timeFrame: At the beginning of the study (0 day) and at the end of the eighth week of the intervention (8 weeks)
measure: Change in systemic inflammatory marker Interleukin 6 (IL-6)
timeFrame: At the beginning of the study (0 day) and at the end of the eighth week of the intervention (8 weeks)
measure: Number of participants with infection
timeFrame: At the beginning of the study (0 day) and at the end of the eighth week of the intervention (8 weeks)
measure: Results of the SF36 questionnaire at inclusion
timeFrame: Day 0
measure: Results of the SF36 questionnaire at Month 2
timeFrame: Month 2
Secondary outcomes:
measure: Percentage rate of re-epithelialization
timeFrame: Participants will be followed for the duration of 8 weeks
Other outcomes:
Locations:
city: Thessaloniki
country: Greece
facility: Medical School, Aristotle University of Thessaloniki
city: Mashhad
country: Iran, Islamic Republic of
facility: Mashhad University of Medical Sciences
state: Razavi Khorasan
Study officials:
affiliation: Surgical Oncology Research Center, Mashhad University of Medical Sciences, Mashhad, Iran.
name: Daryoush Hamidi Alamdari, Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Medical School, Aristotle University of Thessaloniki, Thessaloniki, Greece.
name: George Koliakos, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: