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%).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
40
The first intervention group includes 10 patients with chronic wounds who, despite common treatment, will be undergone PRP-FG intervention for 8 weeks.
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.
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.
Medical School, Aristotle University of Thessaloniki
Thessaloniki, Greece
NOT_YET_RECRUITINGMashhad University of Medical Sciences
Mashhad, Razavi Khorasan Province, Iran
RECRUITINGWound 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 8 weeks
Change in the systemic inflammatory marker C-reactive protein (CRP)
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)
Change in systemic inflammatory marker erythrocyte sedimentation rate (ESR)
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)
Change in systemic inflammatory marker Interleukin 6 (IL-6)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
For 10 patients with chronic wounds, only the classical wound irrigation by normal saline will be continued for 8 weeks.
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)
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.
Time frame: 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.
Time frame: 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.
Time frame: Month 2
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.
Time frame: Participants will be followed for the duration of 8 weeks