Repairing Gel (Supraz) and Platelet-rich Plasma-Fibrin Glue (PRP-FG) in Eliminating Odor and Healing the Malodorous Chronic Wounds Versus Standard of Care
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Wound Size Change
研究概览
简要总结
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.
详细描述
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%).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Platelet-Rich Plasma-Fibrin Glue
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.
干预措施: Platelet-Rich Plasma-Fibrin Glue (Drug)
Repairing Gel
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)
干预措施: Repairing Gel (Drug)
Platelet-Rich Plasma-Fibrin Glue and Repairing Gel
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.
干预措施: Repairing Gel and Platelet-Rich Plasma-Fibrin Glue (Drug)
Classical wound irrigation (control)
For 10 patients with chronic wounds, only classical wound irrigation by normal saline (0.9%) will be continued for 8 weeks.
干预措施: Classical wound irrigation (control) (Other)
结局指标
主要结局
Wound Size Change
时间窗: 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.
Wound Odor Change
时间窗: 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).
Visual Analog Scale changes for pain assessment
时间窗: 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.
Duration of recovery
时间窗: 8 weeks
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)
时间窗: 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)
Change in systemic inflammatory marker Interleukin 6 (IL-6)
时间窗: 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)
Number of participants with infection
时间窗: 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.
Results of the SF36 questionnaire at Month 2
时间窗: 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.
Results of the SF36 questionnaire at inclusion
时间窗: 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.
Change in systemic inflammatory marker erythrocyte sedimentation rate (ESR)
时间窗: 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)
次要结局
- Percentage rate of re-epithelialization(Participants will be followed for the duration of 8 weeks)
研究者
Daryoush Hamidi Alamdari, PhD
Associate professor
Mashhad University of Medical Sciences