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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Normal Saline Dressing | Active Comparator | Conventional sterile saline dressings are applied daily over ~4 weeks, with follow-up until 12 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Autologous Platelet-Rich Plasma (PRP) Dressing | Biological | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Wound Healing Status | Wound status based on presence of granulation tissue and measurement of wound size. | Up to 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of healing | Number of days from baseline until there is no further change in wound size. | Up to 12 weeks |
| Percentage Change in Longitudinal Wound Dimension | Calculated as (baseline longitudinal size - size at 12 weeks) ÷ baseline longitudinal size × 100. |
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Inclusion Criteria :
Exclusion Criteria :
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Services Hospital Lahore | Lahore | Punjab Province | Pakistan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28529414 | Background | Somani A, Rai R. Comparison of Efficacy of Autologous Platelet-rich Fibrin versus Saline Dressing in Chronic Venous Leg Ulcers: A Randomised Controlled Trial. J Cutan Aesthet Surg. 2017 Jan-Mar;10(1):8-12. doi: 10.4103/JCAS.JCAS_137_16. | |
| 31811339 | Background | Elsaid A, El-Said M, Emile S, Youssef M, Khafagy W, Elshobaky A. Randomized Controlled Trial on Autologous Platelet-Rich Plasma Versus Saline Dressing in Treatment of Non-healing Diabetic Foot Ulcers. World J Surg. 2020 Apr;44(4):1294-1301. doi: 10.1007/s00268-019-05316-0. |
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Individual participant data collected in this study will not be shared outside the study team to protect participant privacy and in accordance with local regulations.
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| ID | Term |
|---|---|
| D001458 | Bandages |
| ID | Term |
|---|---|
| D004864 | Equipment and Supplies |
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Two-arm randomized controlled trial, 1:1 allocation by lottery method (PRP dressing vs normal saline dressing).
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No Blinding
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| Normal Saline Dressings | Other | Conventional sterile normal saline dressings are applied over ~4 weeks, with outpatient follow-up until 12 weeks. |
|
| 12 weeks |
| Percentage Change in Horizontal Wound Dimension | Calculated as (baseline horizontal size-sizeat12weeks)÷base line horizontal size X 100 | 12 weeks |