Platelet-Rich Plasma Versus Saline Dressings in Pediatric Heel Pad Injuries

NCT07377708 | Completed

• 1 other identifier: IRB/2023/1091/SIMS
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Wheel Spoke Injury; Heel Pad Injuries; Wound Healing

Keywords

Platelet Rich Plasma (PRP); Saline Dressing; Wound Care Trauma - Pediatric; Motorcycle Injuries; Soft Tissue Repair; Pediatric Surgery

Outcome Measures

Primary Outcomes (1)

• Wound Healing Status

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

  Up to 12 weeks

Secondary Outcomes (3)

• Duration of healing

  Up to 12 weeks

• Percentage Change in Longitudinal Wound Dimension

  12 weeks

• Percentage Change in Horizontal Wound Dimension

  12 weeks

Study Arms (2)

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.

Biological: Autologous Platelet-Rich Plasma (PRP) Dressing

Normal Saline Dressing

ACTIVE COMPARATOR

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

Other: Normal Saline Dressings

Interventions

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.

Autologous Platelet-Rich Plasma Dressings

Normal Saline Dressings OTHER

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

Normal Saline Dressing

Eligibility Criteria

• Age: 5 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Services Institute of Medical Sciences, Pakistan: lead

Study Sites (1)

Services Hospital Lahore

Lahore, Punjab Province, Pakistan

Location

Related Publications (2)

• 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.

  PMID: 28529414 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.

  PMID: 31811339 BACKGROUND

MeSH Terms

Interventions

Bandages

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: No Blinding
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Head of Pediatric Surgery Department

Model Details: Two-arm randomized controlled trial, 1:1 allocation by lottery method (PRP dressing vs normal saline dressing).

Study Record Dates

• First Submitted: January 22, 2026
• First Posted: January 30, 2026
• Study Start: April 16, 2024
• Primary Completion: April 30, 2025
• Study Completion: April 30, 2025
• Last Updated: February 2, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)