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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.
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%).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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) |
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| 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. |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mashhad University of Medical Sciences | Mashhad | Razavi Khorasan Province | 99191-91778 | Iran |
All data related to the project after the unidentifiable people will be shared.
Access to data is allowed 6 months after the publication of results.
The investigator's data will be available to university staff and academic institutions.
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| 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. |
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| 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. |
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| 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. |
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| 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 |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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