Clinical trial NCT00858442: Platelet-Rich Plasma (PRP) in Reconstructive Surgery on Children With Retractable Burn Sequelae on Extremities
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Burns
Keywords: Burn sequelae
PRP
Children
Lead sponsor: Corporation for the Aid of Burned Children
Sponsor class: OTHER
Collaborators: name: Zimmer Biomet
First posted: 2009-03-09
Enrollment: 44
Sex: ALL
Minimum age (years): 5
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Median Time Between Surgery Date and Start Date Compression.
timeFrame: day
Secondary outcomes:
measure: Width of the Graft
timeFrame: start and end compression
measure: Length of the Graft
timeFrame: start and end compression
Other outcomes:
Locations:
city: Santiago
country: Chile
facility: Coaniquem
state: Pudahuel
Study officials:
affiliation: Corporation for the Aid of Burned Children
name: M B Quezada, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Kazakos K, Lyras DN, Verettas D, Tilkeridis K, Tryfonidis M. The use of autologous PRP gel as an aid in the management of acute trauma wounds. Injury. 2009 Aug;40(8):801-5. doi: 10.1016/j.injury.2008.05.002. Epub 2008 Aug 13.