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

NCT05983302 | Active Not Recruiting Phase 2

• 1 other identifier: IR.MUMS.REC.1402.089
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Wounds and Injuries

Keywords

Platelet-Rich Plasma-Fibrin Glue; Repairing Gel; Chronic Wounds; Malodorous; Recalcitrant

Outcome Measures

Primary Outcomes (10)

• 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)

• 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)

• 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

• Duration of recovery

  The duration of recovery, which is the number of days it will be taken for the wound to heal.

  8 weeks

• 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)

• 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)

• 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)

• 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)

• 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

• 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 Outcomes (1)

• Percentage rate of re-epithelialization

  Participants will be followed for the duration of 8 weeks

Study Arms (4)

Platelet-Rich Plasma-Fibrin Glue

EXPERIMENTAL

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

Repairing Gel

EXPERIMENTAL

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

Platelet-Rich Plasma-Fibrin Glue and Repairing Gel

EXPERIMENTAL

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

Classical wound irrigation (control)

EXPERIMENTAL

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)

Interventions

Platelet-Rich Plasma-Fibrin Glue DRUG

The first intervention group includes 10 patients with chronic wounds who, despite common treatment, will be undergone PRP-FG intervention for 8 weeks.

Also known as: PRP-FG

Platelet-Rich Plasma-Fibrin Glue

Repairing Gel DRUG

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.

Also known as: Supraz Gel

Repairing Gel

Repairing Gel and Platelet-Rich Plasma-Fibrin Glue DRUG

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.

Also known as: Supraz Gel and PRP-FG

Platelet-Rich Plasma-Fibrin Glue and Repairing Gel

Classical wound irrigation (control) OTHER

For 10 patients with chronic wounds, only the classical wound irrigation by normal saline will be continued for 8 weeks.

Also known as: Control

Classical wound irrigation (control)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mashhad University of Medical Sciences: lead

Study Sites (1)

Mashhad University of Medical Sciences

Mashhad, Razavi Khorasan Province, 99191-91778, Iran

Location

MeSH Terms

Conditions

Wounds and Injuries

Study Officials

• Daryoush Hamidi Alamdari, Ph.D

  Surgical Oncology Research Center, Mashhad University of Medical Sciences, Mashhad, Iran.

  PRINCIPAL INVESTIGATOR

• Daryoush Hamidi Alamdari

  Surgical Oncology Research Center, Mashhad University of Medical Sciences, Mashhad, Iran.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 30, 2023
• First Posted: August 9, 2023
• Study Start: August 20, 2023
• Primary Completion: January 20, 2024
• Study Completion (Estimated): March 20, 2027
• Last Updated: May 6, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Access to data is allowed 6 months after the publication of results.
• Access Criteria: The investigator's data will be available to university staff and academic institutions.

Locations

IR (1)