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

This study has been completed.
Sponsor:
Collaborator:
Biomet, Inc.
Information provided by (Responsible Party):
maría beatriz quezada, Corporation for the Aid of Burned Children
ClinicalTrials.gov Identifier:
NCT00858442
First received: March 5, 2009
Last updated: January 28, 2015
Last verified: January 2015
  Purpose

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?


Condition Intervention
Burns
Procedure: With PRP

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Corporation for the Aid of Burned Children:

Primary Outcome Measures:
  • Median Time Between Surgery Date and Start Date Compression. [ Time Frame: day ] [ Designated as safety issue: No ]
    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:
  • Width of the Graft [ Time Frame: start and end compression ] [ Designated as safety issue: No ]
    Central width measurement graft between the start and the end of the compression

  • Length of the Graft [ Time Frame: start and end compression ] [ Designated as safety issue: No ]
    Central length measurement graft between the start and the end of the compression


Enrollment: 44
Study Start Date: March 2009
Study Completion Date: November 2012
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

Ages Eligible for Study:   5 Years to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00858442

Locations
Chile
Coaniquem
Santiago, Pudahuel, Chile
Sponsors and Collaborators
Corporation for the Aid of Burned Children
Biomet, Inc.
Investigators
Principal Investigator: M B Quezada, MD Corporation for the Aid of Burned Children
  More Information

Additional Information:
Publications:

Responsible Party: maría beatriz quezada, md, Corporation for the Aid of Burned Children
ClinicalTrials.gov Identifier: NCT00858442     History of Changes
Other Study ID Numbers: 1-Quezada
Study First Received: March 5, 2009
Results First Received: April 18, 2013
Last Updated: January 28, 2015
Health Authority: Chile: Comisión Nacional de Investigación Científica y Tecnológica

Keywords provided by Corporation for the Aid of Burned Children:
Burn sequelae
PRP
Children

Additional relevant MeSH terms:
Burns
Wounds and Injuries

ClinicalTrials.gov processed this record on August 31, 2015