Platelet-Rich Plasma (PRP) in Reconstructive Surgery on Children With Retractable Burn Sequelae on Extremities
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|ClinicalTrials.gov Identifier: NCT00858442|
Recruitment Status : Completed
First Posted : March 9, 2009
Results First Posted : January 26, 2015
Last Update Posted : February 13, 2015
|Condition or disease||Intervention/treatment||Phase|
|Burns||Procedure: With PRP||Not Applicable|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||44 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Outcomes Assessor)|
|Official Title:||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|
|Study Start Date :||March 2009|
|Actual Primary Completion Date :||October 2011|
|Actual Study Completion Date :||November 2012|
Experimental: With PRP
Each patient received a single dose of 5cc PRP before the graft.
Procedure: With PRP
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.
No Intervention: Without PRP
Control patients did not receive any intervention before the graft.
- Median Time Between Surgery Date and Start Date Compression. [ Time Frame: 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
- Width of the Graft [ Time Frame: start and end compression ]Central width measurement graft between the start and the end of the compression
- Length of the Graft [ Time Frame: start and end compression ]Central length measurement graft between the start and the end of the compression
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00858442
|Santiago, Pudahuel, Chile|
|Principal Investigator:||M B Quezada, MD||Corporation for the Aid of Burned Children|