Back to resultsElimination of Odor and Treatment of Malodorous Recalcitrant Wounds by Using Supraz and PRP-FG Versus Standard of Care
Primary Purpose
Wounds and Injuries
Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Platelet-Rich Plasma-Fibrin Glue
Repairing Gel
Repairing Gel and Platelet-Rich Plasma-Fibrin Glue
Classical wound irrigation (control)
Sponsored by
About this trial
This is an interventional treatment trial for Wounds and Injuries focused on measuring Platelet-Rich Plasma-Fibrin Glue, Repairing Gel, Chronic Wounds, Malodorous, Recalcitrant
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
Sites / Locations
- Medical School, Aristotle University of Thessaloniki
- Mashhad University of Medical SciencesRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
Platelet-Rich Plasma-Fibrin Glue
Repairing Gel
Platelet-Rich Plasma-Fibrin Glue and Repairing Gel
Classical wound irrigation (control)
Arm Description
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.
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)
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.
For 10 patients with chronic wounds, only classical wound irrigation by normal saline (0.9%) will be continued for 8 weeks.
Outcomes
Primary Outcome Measures
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).
Wound Size Change
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
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
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)
C-reactive protein (CRP)
Change in systemic inflammatory marker erythrocyte sedimentation rate (ESR)
erythrocyte sedimentation rate (ESR)
Change in systemic inflammatory marker Interleukin 6 (IL-6)
Interleukin 6 (IL-6)
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.
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.
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT05983302
First Posted
June 30, 2023
Last Updated
September 21, 2023
Sponsor
Mashhad University of Medical Sciences
Collaborators
Aristotle University Of Thessaloniki
1. Study Identification
Unique Protocol Identification Number
NCT05983302
Brief Title
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
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 20, 2023 (Actual)
Primary Completion Date
January 20, 2024 (Anticipated)
Study Completion Date
March 20, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mashhad University of Medical Sciences
Collaborators
Aristotle University Of Thessaloniki
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
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%).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wounds and Injuries
Keywords
Platelet-Rich Plasma-Fibrin Glue, Repairing Gel, Chronic Wounds, Malodorous, Recalcitrant
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Factorial Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Platelet-Rich Plasma-Fibrin Glue
Arm Type
Experimental
Arm Description
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.
Arm Title
Repairing Gel
Arm Type
Experimental
Arm Description
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)
Arm Title
Platelet-Rich Plasma-Fibrin Glue and Repairing Gel
Arm Type
Experimental
Arm Description
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.
Arm Title
Classical wound irrigation (control)
Arm Type
Experimental
Arm Description
For 10 patients with chronic wounds, only classical wound irrigation by normal saline (0.9%) will be continued for 8 weeks.
Intervention Type
Drug
Intervention Name(s)
Platelet-Rich Plasma-Fibrin Glue
Other Intervention Name(s)
PRP-FG
Intervention Description
The first intervention group includes 10 patients with chronic wounds who, despite common treatment, will be undergone PRP-FG intervention for 8 weeks.
Intervention Type
Drug
Intervention Name(s)
Repairing Gel
Other Intervention Name(s)
Supraz Gel
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Repairing Gel and Platelet-Rich Plasma-Fibrin Glue
Other Intervention Name(s)
Supraz Gel and PRP-FG
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Classical wound irrigation (control)
Other Intervention Name(s)
Control
Intervention Description
For 10 patients with chronic wounds, only the classical wound irrigation by normal saline will be continued for 8 weeks.
Primary Outcome Measure Information:
Title
Wound Odor Change
Description
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).
Time Frame
At the beginning of the study (0 day) and at the end of the eighth week of the intervention (8 weeks)
Title
Wound Size Change
Description
Change from Baseline Wound Size (length and width) at 2 months will be assessed in digital images taken of the wound.
Time Frame
At the beginning of the study (0 day) and at the end of the eighth week of the intervention (8 weeks)
Title
Visual Analog Scale changes for pain assessment
Description
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.
Time Frame
Every 48 hours for 8 weeks
Title
Duration of recovery
Description
The duration of recovery, which is the number of days it will be taken for the wound to heal.
Time Frame
8 weeks
Title
Change in the systemic inflammatory marker C-reactive protein (CRP)
Description
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)
Title
Change in systemic inflammatory marker erythrocyte sedimentation rate (ESR)
Description
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)
Title
Change in systemic inflammatory marker Interleukin 6 (IL-6)
Description
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)
Title
Number of participants with infection
Description
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.
Time Frame
At the beginning of the study (0 day) and at the end of the eighth week of the intervention (8 weeks)
Title
Results of the SF36 questionnaire at inclusion
Description
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.
Time Frame
Day 0
Title
Results of the SF36 questionnaire at Month 2
Description
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.
Time Frame
Month 2
Secondary Outcome Measure Information:
Title
Percentage rate of re-epithelialization
Description
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.
Time Frame
Participants will be followed for the duration of 8 weeks
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Daryoush Hamidi Alamdari, Ph.D
Phone
+98 9151017650
Email
hamidiad@mums.ac.ir
First Name & Middle Initial & Last Name or Official Title & Degree
Elaheh Emadi, Ph.D
Phone
+98 9355850931
Email
EmadiE4001@mums.ac.ir
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daryoush Hamidi Alamdari, Ph.D
Organizational Affiliation
Surgical Oncology Research Center, Mashhad University of Medical Sciences, Mashhad, Iran.
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
George Koliakos, MD, PhD
Organizational Affiliation
Medical School, Aristotle University of Thessaloniki, Thessaloniki, Greece.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical School, Aristotle University of Thessaloniki
City
Thessaloniki
Country
Greece
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
George Koliakos, MD, PhD
Phone
00306944677745
Email
koliakos@yahoo.gr
Facility Name
Mashhad University of Medical Sciences
City
Mashhad
State/Province
Razavi Khorasan
ZIP/Postal Code
99191-91778
Country
Iran, Islamic Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daryoush Hamidi Alamdari, Ph.D
Phone
00989151017650
Email
hamidiad@mums.ac.ir
First Name & Middle Initial & Last Name & Degree
Elaheh Emadi, Ph.D
Phone
98 9355850931
Email
EmadiE4001@mums.ac.ir
First Name & Middle Initial & Last Name & Degree
George Koliakos, MD, Ph.D
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
All data related to the project after the unidentifiable people will be shared.
IPD Sharing Time Frame
Access to data is allowed 6 months after the publication of results.
IPD Sharing Access Criteria
The investigator's data will be available to university staff and academic institutions.
Learn more about this trial
Elimination of Odor and Treatment of Malodorous Recalcitrant Wounds by Using Supraz and PRP-FG Versus Standard of Care
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