Elimination of Odor and Treatment of Malodorous Recalcitrant Wounds by Using Supraz and PRP-FG Versus Standard of Care

Wounds and Injuries Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05983302
• Other study ID #: IR.MUMS.REC.1402.089
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: August 20, 2023
• Est. completion date: March 20, 2024

Study information

• Verified date: March 2024
• Source: Mashhad University of Medical Sciences
• Contact: Daryoush Hamidi Alamdari, Ph.D
• Phone: +98 9151017650
• Email: hamidiad[@]mums.ac.ir
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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%).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: March 20, 2024
• Est. primary completion date: January 20, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Wounds and Injuries

Intervention

Drug:
• 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.

Other:
• Classical wound irrigation (control)
For 10 patients with chronic wounds, only the classical wound irrigation by normal saline will be continued for 8 weeks.

Locations

Country	Name	City	State
Greece	Medical School, Aristotle University of Thessaloniki	Thessaloniki
Iran, Islamic Republic of	Mashhad University of Medical Sciences	Mashhad	Razavi Khorasan

Sponsors (2)

Lead Sponsor	Collaborator
Mashhad University of Medical Sciences	Aristotle University Of Thessaloniki

Countries where clinical trial is conducted

Greece,  Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Wound Odor Change	Change from Baseline Wound Odor intensity at 2 months will be assessed by the nurse using a Visual Analog Scale (VAS) from 0 to 100 (perceived odor).	At the beginning of the study (0 day) and at the end of the eighth week of the intervention (8 weeks)
Primary	Wound Size Change	Change from Baseline Wound Size (length and width) at 2 months will be assessed in digital images taken of the wound.	At the beginning of the study (0 day) and at the end of the eighth week of the intervention (8 weeks)
Primary	Visual Analog Scale changes for pain assessment	Pain will be evaluated by the visual analog scale system (VAS) which assesses changes in pain via a continuous measurement instrument. The score is determined by measuring the distance (mm) between the no-pain anchor to the point that the patient marks, providing a range of scores from 0 - 10. A higher score indicates greater pain intensity.	Every 48 hours for 8 weeks
Primary	Duration of recovery	The duration of recovery, which is the number of days it will be taken for the wound to heal.	8 weeks
Primary	Change in the systemic inflammatory marker C-reactive protein (CRP)	C-reactive protein (CRP)	At the beginning of the study (0 day) and at the end of the eighth week of the intervention (8 weeks)
Primary	Change in systemic inflammatory marker erythrocyte sedimentation rate (ESR)	erythrocyte sedimentation rate (ESR)	At the beginning of the study (0 day) and at the end of the eighth week of the intervention (8 weeks)
Primary	Change in systemic inflammatory marker Interleukin 6 (IL-6)	Interleukin 6 (IL-6)	At the beginning of the study (0 day) and at the end of the eighth week of the intervention (8 weeks)
Primary	Number of participants with infection	A swab culture: Identify a small area (1 cm) of clean viable tissue and rotate the swab on it for 5 seconds while applying enough pressure to produce exudate and culture it to detect bacteria.	At the beginning of the study (0 day) and at the end of the eighth week of the intervention (8 weeks)
Primary	Results of the SF36 questionnaire at inclusion	The SF-36 questionnaire is a quality-of-life questionnaire that includes 36 questions divided into 8 different categories (physical functioning, limitations due to physical condition, physical pain, perceived health, vitality, social functioning or well-being, limitations due to mental condition, mental health). These 8 dimensions are used to calculate two scores on the quality of life of individuals: the physical composite score and the mental composite score. The higher the score, the greater the capacity. It is self-administered and takes less than 10 minutes. Higher scores indicate better quality of life. The French version has been validated and has satisfactory psychometric properties. Score from 0 to 100.	Day 0
Primary	Results of the SF36 questionnaire at Month 2	The SF-36 questionnaire is a quality-of-life questionnaire that includes 36 questions divided into 8 different categories (physical functioning, limitations due to physical condition, physical pain, perceived health, vitality, social functioning or well-being, limitations due to mental condition, mental health). These 8 dimensions are used to calculate two scores on the quality of life of individuals: the physical composite score and the mental composite score. The higher the score, the greater the capacity. It is self-administered and takes less than 10 minutes. Higher scores indicate better quality of life. The French version has been validated and has satisfactory psychometric properties. Score from 0 to 100.	Month 2
Secondary	Percentage rate of re-epithelialization	Pictures taken of the wound site every other day will be analyzed using imaging software for the size of the wound. The percentage rate will be calculated from this.	Participants will be followed for the duration of 8 weeks