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NCT Number: NCT05983302

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Wounds and Injuries

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Mashhad University of Medical Sciences

Mashhad, Razavi Khorasan Province, 99191-91778, Iran

About this study

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%).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: PRP-FG

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.

Other names: Supraz 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.

Other names: Supraz Gel and PRP-FG

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.

Other names: Control

Primary outcomes

  1. Wound Odor Change

    Time frame: 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).

  2. Wound Size Change

    Time frame: 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.

  3. Visual Analog Scale changes for pain assessment

    Time frame: 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.

  4. Duration of recovery

    Time frame: 8 weeks

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

  5. Change in the systemic inflammatory marker C-reactive protein (CRP)

    Time frame: 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)

  6. Change in systemic inflammatory marker erythrocyte sedimentation rate (ESR)

    Time frame: 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)

  7. Change in systemic inflammatory marker Interleukin 6 (IL-6)

    Time frame: 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)

  8. Number of participants with infection

    Time frame: 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.

  9. Results of the SF36 questionnaire at inclusion

    Time frame: 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.

  10. Results of the SF36 questionnaire at Month 2

    Time frame: 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 outcomes

  1. Percentage rate of re-epithelialization

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Mashhad University of Medical Sciences

Other

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2024
Study completion
2027
First posted
Aug 9, 2023
Registry last updated
May 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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