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

Not Applicable

Completed

• Conditions: Burns
• Interventions: Procedure: With PRP

• Registration Number: NCT00858442
• Lead Sponsor: Corporation for the Aid of Burned Children

Brief Summary

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

Hypothesis:

1. 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).

2. 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.

Study Timeline

• Study Start: 2009-03
• Study First Submitted: 2009-03-05
• Study First Submitted QC: 2009-03-05
• Study First Posted: 2009-03-09
• Primary Completion: 2011-10
• Study Completion: 2012-11
• Results First Submitted: 2013-04-18
• Status Verified: 2015-01
• Results First Submitted QC: 2015-01-22
• Results First Posted: 2015-01-26
• Last Update Submitted: 2015-01-28
• Last Update Posted: 2015-02-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
With PRP	With PRP	Each patient received a single dose of 5cc PRP before the graft.

Primary Outcome Measures

Name	Time	Method
Median Time Between Surgery Date and Start Date Compression.	day	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

Secondary Outcome Measures

Name	Time	Method
Width of the Graft	start and end compression	Central width measurement graft between the start and the end of the compression
Length of the Graft	start and end compression	Central length measurement graft between the start and the end of the compression

Trial Locations

Locations (1)

Coaniquem; 🇨🇱 Santiago, Pudahuel, Chile