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临床试验/NCT07377708
NCT07377708已完成不适用

A Comparison of Autologous Platelet-Rich Plasma Dressing Versus Saline Dressing in the Management of Pediatric Heel Pad Injuries Due to Motorcycle Wheel-Spoke Trauma

Services Institute of Medical Sciences, Pakistan1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年4月16日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
1
主要终点
Wound Healing Status

研究概览

简要总结

This study is testing whether autologous platelet rich plasma (PRP) dressings are more effective than normal saline dressings in treating heel pad injuries caused by motorcycle wheel spokes among children in Pakistan. PRP is prepared from a child's own blood and contains natural growth factors that may help wounds to heal faster. The study compares healing rates, reduction in wound size, and time to complete wound healing between the platelet-rich plasma and saline dressing groups.

详细描述

Motorcycle wheel-spoke injuries occur when the heel or foot becomes entrapped in the spokes of a moving motorcycle, frequently resulting in severe soft tissue damage in children. Healing of these injuries is often prolonged and challenging. Platelet-rich plasma (PRP), prepared from a patient's own blood, contains a high concentration of growth factors that promote tissue regeneration, angiogenesis, and wound contraction. Previous studies in adults with diabetic and chronic ulcers have demonstrated that PRP may accelerate wound healing compared with conventional dressings.

However, evidence supporting the use of PRP in the pediatric population, particularly for heel pad injuries resulting from motorcycle wheel-spoke trauma, remains limited. This randomized controlled trial is designed to evaluate the efficacy of platelet-rich plasma dressing compared with saline dressing in children aged 5 to 12 years presenting with heel pad injuries.

A total of 60 participants will be enrolled and randomly assigned to receive either platelet-rich plasma dressing or saline dressing. Study outcomes will include wound healing within 12 weeks, duration of wound healing in days, and changes in wound size measured in both longitudinal and horizontal dimensions. This trial aims to generate evidence for a more effective and locally feasible wound management strategy for pediatric heel pad injuries in the study setting.

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
None

盲法说明

No Blinding

入排标准

年龄范围
5 Years 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children aged 5-12 years
  • Both genders
  • Presenting with heel pad injuries caused by motorcycle wheel-spoke trauma

排除标准

  • Children with wounds older than 3 weeks
  • Children with wounds resulting from comorbidities

研究组 & 干预措施

Autologous Platelet-Rich Plasma Dressings

Experimental

Approximately 10 mL of venous blood is processed to prepare PRP, which is applied as a wound dressing for 3 days. Applied for about 4 weeks, with follow-up until 12 weeks.

干预措施: Autologous Platelet-Rich Plasma (PRP) Dressing (Biological)

Normal Saline Dressing

Active Comparator

Conventional sterile saline dressings are applied daily over ~4 weeks, with follow-up until 12 weeks.

干预措施: Normal Saline Dressings (Other)

结局指标

主要结局

Wound Healing Status

时间窗: Up to 12 weeks

Wound status based on presence of granulation tissue and measurement of wound size.

次要结局

  • Duration of healing(Up to 12 weeks)
  • Percentage Change in Longitudinal Wound Dimension(12 weeks)
  • Percentage Change in Horizontal Wound Dimension(12 weeks)

研究者

发起方
Services Institute of Medical Sciences, Pakistan
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Fatima Numeri

Professor and Head of Pediatric Surgery Department

Services Institute of Medical Sciences, Pakistan

研究点 (1)

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