Heel Pad Injuries, Wheel Spoke Injury, Wound Healing
Conditions
Keywords
Platelet Rich Plasma (PRP), Saline Dressing, Wound Care Trauma - Pediatric, Motorcycle Injuries, Soft Tissue Repair, Pediatric Surgery
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.
Interventions
BIOLOGICALAutologous Platelet-Rich Plasma (PRP) Dressing
Approximately 10 mL of venous blood is processed in the pathology department to prepare PRP, which is applied as a wound dressing. Dressings are applied over \~4 weeks, with outpatient follow-up until 12 weeks.
OTHERNormal Saline Dressings
Conventional sterile normal saline dressings are applied over \~4 weeks, with outpatient follow-up until 12 weeks.
Sponsors
Services Institute of Medical Sciences, Pakistan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
No Blinding
Intervention model description
Two-arm randomized controlled trial, 1:1 allocation by lottery method (PRP dressing vs normal saline dressing).
Eligibility
Sex/Gender
ALL
Age
5 Years to 12 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Wound Healing Status | Up to 12 weeks | Wound status based on presence of granulation tissue and measurement of wound size. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of healing | Up to 12 weeks | Number of days from baseline until there is no further change in wound size. |
| Percentage Change in Longitudinal Wound Dimension | 12 weeks | Calculated as (baseline longitudinal size - size at 12 weeks) ÷ baseline longitudinal size × 100. |
| Percentage Change in Horizontal Wound Dimension | 12 weeks | Calculated as (baseline horizontal size-sizeat12weeks)÷base line horizontal size X 100 |
Countries
Pakistan
Outcome results
None listed