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
Overview
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Services Institute of Medical Sciences, Pakistan
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Wound Healing Status
Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Masking Description
No Blinding
Eligibility Criteria
- Ages
- 5 Years to 12 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Children aged 5-12 years
- •Both genders
- •Presenting with heel pad injuries caused by motorcycle wheel-spoke trauma
Exclusion Criteria
- •Children with wounds older than 3 weeks
- •Children with wounds resulting from comorbidities
Arms & Interventions
Autologous Platelet-Rich Plasma Dressings
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.
Intervention: Autologous Platelet-Rich Plasma (PRP) Dressing (Biological)
Normal Saline Dressing
Conventional sterile saline dressings are applied daily over ~4 weeks, with follow-up until 12 weeks.
Intervention: Normal Saline Dressings (Other)
Outcomes
Primary Outcomes
Wound Healing Status
Time Frame: Up to 12 weeks
Wound status based on presence of granulation tissue and measurement of wound size.
Secondary Outcomes
- Duration of healing(Up to 12 weeks)
- Percentage Change in Longitudinal Wound Dimension(12 weeks)
- Percentage Change in Horizontal Wound Dimension(12 weeks)
Investigators
Fatima Numeri
Professor and Head of Pediatric Surgery Department
Services Institute of Medical Sciences, Pakistan