Platelet Rich Plasma (PRP) Bio Stimulant Gel Dressing in Treating Chronic Non Healing Leg and Foot Ulcers: Cost and Effectiveness
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- change the ulcer size
研究概览
简要总结
Background
Chronic non-healing ulcer is a common problem met in clinical practice and represents a burden to the patients. Chronic ulcer lacks growth factors (GFs) to promote the healing process and is frequently followed by superadded infections. Ordinary technique such as wound debridement and regular dressings cannot provide adequate results as these techniques cannot provide the necessary GFs. Platelet-rich plasma (PRP) helps wound healing by releasing various types of GFs.
The aim: to evaluate and compare the efficacy of PRP dressing versus traditional dressings in the treatment of chronic non-healing leg and foot ulcers of different etiology as regard cost of overall treatment and effectiveness (reduction of the size of the ulcer and safety of the technique).
Methods
This prospective study was performed on inpatients and outpatients in general surgery department, Zagazig university hospital from June 2017 to January 2019. Patients were divided randomly into two groups: group A received PRP dressing (N=22, 50%) and group B received conventional ordinary dressing (N=22, 50%).The mean follow-up period was 3 months after the last dressing. Patients treated with PRP at once-weekly interval for a maximum of 12 dressings while patients with ordinary dressings may need one dressing every other day for a maximum of 12 weeks. The reduction in the size of the ulcers (area and volume) in both groups was assessed using centimeter scale and Digital photographs before and after each session and during follow up period.
Keywords: Platelet-rich plasma, ulcers, non-healing, ordinary dressing.
详细描述
Chronic non-healing ulcer is a common problem met in clinical practice and represents a burden to the patients. Chronic ulcer lacks growth factors (GFs) to promote the healing process and is frequently followed by superadded infections. Ordinary technique such as wound debridement and regular dressings cannot provide adequate results as these techniques cannot provide the necessary GFs. Platelet-rich plasma (PRP) helps wound healing by releasing various types of GFs.
The aim: to evaluate and compare the efficacy of PRP dressing versus traditional dressings in the treatment of chronic non-healing leg and foot ulcers of different etiology as regard cost of overall treatment and effectiveness (reduction of the size of the ulcer and safety of the technique).
Methods
This prospective study was performed on inpatients and outpatients in general surgery department, Zagazig university hospital from June 2017 to January 2019. Patients were divided randomly into two groups: group A received PRP dressing (N=22, 50%) and group B received conventional ordinary dressing (N=22, 50%).The mean follow-up period was 3 months after the last dressing. Patients treated with PRP at once-weekly interval for a maximum of 12 dressings while patients with ordinary dressings may need one dressing every other day for a maximum of 12 weeks. The reduction in the size of the ulcers (area and volume) in both groups was assessed using centimeter scale and Digital photographs before and after each session and during follow up period.
Keywords: Platelet-rich plasma, ulcers, non-healing, ordinary dressing.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18-80 years old,
- •males and non-pregnant females,
- •hemoglobin (> 10 gm. /dL),
- •post-prandial blood sugar ≤ 140 mg% if diabetic,
- •Wounds free of infection (sterile swab) or necrosis.
排除标准
- •malignant ulcer(by biopsy),
- •pus discharge/slough,
- •ulcer with exposed tendons/ligaments/bone,
- •ischemic ulcer (by duplex U/S),
- •non-compliant patients ,
- •radiation near to the site of ulcer,
- •osteomyelitis of underlying bone (x-ray-bone scan) ,
- •steroids therapy ,
- •thrombocytopenia(< 150,000/dl)
- •patients unfit or refuse blood donation from himself or from others.
研究组 & 干预措施
PRP dressing
干预措施: PRP dressing (Procedure)
conventional ordinary dressing
干预措施: conventional ordinary dressing (Procedure)
结局指标
主要结局
change the ulcer size
时间窗: 1.8 years
healing of the ulcer is assessed using centimeter scale before each dressing
次要结局
未报告次要终点
研究者
Tamer Alsaied Alnaimy
clinical professour
Zagazig University