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

Sponsor

Mashhad University of Medical Sciences (Other)

Overall Status

Recruiting

CT.gov ID

NCT05983302

Collaborator

Aristotle University Of Thessaloniki (Other)

Enrollment

Locations

Arms

Anticipated Duration (Months)

Patients Per Site

2.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Wounds and Injuries	Drug: Platelet-Rich Plasma-Fibrin Glue Drug: Repairing Gel Drug: Repairing Gel and Platelet-Rich Plasma-Fibrin Glue Other: Classical wound irrigation (control)	Phase 2/Phase 3

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%).

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Factorial Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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

Anticipated Study Start Date :

Aug 20, 2023

Anticipated Primary Completion Date :

Jan 20, 2024

Anticipated Study Completion Date :

Mar 20, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	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. Other Names: PRP-FG
Experimental: 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)	Drug: 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. Other Names: Supraz Gel
Experimental: 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.	Drug: 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 Names: Supraz Gel and PRP-FG
Experimental: 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.	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. Other Names: Control

Outcome Measures

Primary Outcome Measures

Wound Odor Change [At the beginning of the study (0 day) and at the end of the eighth week of the intervention (8 weeks)]
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).
Wound Size Change [At the beginning of the study (0 day) and at the end of the eighth week of the intervention (8 weeks)]
Change from Baseline Wound Size (length and width) at 2 months will be assessed in digital images taken of the wound.
Visual Analog Scale changes for pain assessment [Every 48 hours for 8 weeks]
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.
Duration of recovery [8 weeks]
The duration of recovery, which is the number of days it will be taken for the wound to heal.
Change in the systemic inflammatory marker 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)]
C-reactive protein (CRP)
Change in systemic inflammatory marker 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)]
erythrocyte sedimentation rate (ESR)
Change in systemic inflammatory marker 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)]
Interleukin 6 (IL-6)
Number of participants with infection [At the beginning of the study (0 day) and at the end of the eighth week of the intervention (8 weeks)]
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.
Results of the SF36 questionnaire at inclusion [Day 0]
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.
Results of the SF36 questionnaire at Month 2 [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.

Secondary Outcome Measures

Percentage rate of re-epithelialization [Participants will be followed for the duration of 8 weeks]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Medical School, Aristotle University of Thessaloniki	Thessaloniki		Greece
2	Mashhad University of Medical Sciences	Mashhad	Razavi Khorasan	Iran, Islamic Republic of	99191-91778

Sponsors and Collaborators

Mashhad University of Medical Sciences
Aristotle University Of Thessaloniki

Investigators

Principal Investigator: Daryoush Hamidi Alamdari, Ph.D, Surgical Oncology Research Center, Mashhad University of Medical Sciences, Mashhad, Iran.
Principal Investigator: George Koliakos, MD, PhD, Medical School, Aristotle University of Thessaloniki, Thessaloniki, Greece.