Platelet-Rich Plasma (PRP) in Reconstructive Surgery on Children With Retractable Burn Sequelae on Extremities

Study Overview
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Brief Summary
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Does the addition of Platelet-Rich Plasma (PRP) to release of burn contractures and skin graft on the limbs of children with retractable burn sequelae reduce the initial time of the compressive treatment and maintain or lower the graft's retraction?

Detailed Description
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Hypothesis: The use of PRP will allow to initiate sooner the compressive treatment during the post graft surgery evolution, in fewer days on average than the traditional method (18 ds). The use of PRP will maintain the same initial size of the graft. The study's domain corresponds to burn sequelae on children in treatment with reconstructive surgery due to retractile sequelae located on their upper and lower limbs, with functional compromise during their growth process. One of the treatments used for this problem is the surgical technique of with release of burn contractures and skin graft. Split skin grafts are at risk of suboptimal take due to bleeding and infection which would, on the one hand, delay the initiation of the rehabilitation with preventive compression to avoid the retraction of the grafted area. 20% of the children that arrive in COANIQUEM (approximately 7,000 annually), require rehabilitation. Of these, 32% have surgery and 9% of those are release of burn contractures and skin graft mainly on extremities.

Official Title
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PRP on Children With Retractable Burn Sequelae Who Have Submitted Release of Burn Contractures and Skin Graft on Their Limbs. A Double-Blind Randomized Clinical Trial

Conditions
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Burns

Intervention / Treatment
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* Procedure: With PRP


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with burn sequelae on their upper or lower limbs Treated with release of burn contractures and skin graft on their upper or lower limbs Between 5 and 21 years old Following instructions in their homes With informed and written consent Weight 35 Kg or more Blood count Hepatic and coagulation tests Paediatric evaluation prior to surgery Exclusion Criteria: Background of blood alterations Another current pathology

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: With PRP<br>Each patient received a single dose of 5cc PRP before the graft. | Procedure: With PRP<br>* Release of burn contractures and skin graft on the affected limb, a rigorous haemostasis. The surgeon must distribute the activated PRP evenly, forming a very fine clot over it. Immediately the split skin graft must be applied, duly fenestrated. The grafted zone will be measured in it's longest width and length, taking a standardized photograph. On the 5th day the nurse will evaluate the graft's conditions. The evaluation will be done following a previously established follow-up protocol. Measurements of width & length of graft and standardized photo taken at the initiation of the compressive system. Measurement of graft's width & length and standardized photo at the end of the compressive system according protocol. Statistical analysis.<br>|
| No Intervention: Without PRP<br>Control patients did not receive any intervention before the graft. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Median Time Between Surgery Date and Start Date Compression. | Participants were followed from the date of surgery and the date of onset of compression for a minimum of 13.5 days and a maximum of 27 days | day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Width of the Graft | Central width measurement graft between the start and the end of the compression | start and end compression | 
| Length of the Graft | Central length measurement graft between the start and the end of the compression | start and end compression | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Burn sequelae, PRP, Children