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

C

Corporation for the Aid of Burned Children

Status

Completed

Conditions

Burns

Treatments

Procedure: With PRP

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT00858442
1-Quezada

Details and patient eligibility

About

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?

Full description

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.

Enrollment

44 patients

Sex

All

Ages

5 to 21 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

44 participants in 2 patient groups

With PRP
Experimental group
Description:
Each patient received a single dose of 5cc PRP before the graft.
Treatment:
Procedure: With PRP
Without PRP
No Intervention group
Description:
Control patients did not receive any intervention before the graft.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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