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Completed

NCT Number: NCT00858442

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

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?

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Key information

Conditions

Burns Wounds and Injuries

Age range

5 year–21 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Coaniquem

Santiago, Pudahuel, Chile

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

With PRP

Procedure

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. Width of the Graft

    Time frame: start and end compression

    Central width measurement graft between the start and the end of the compression

  2. Length of the Graft

    Time frame: start and end compression

    Central length measurement graft between the start and the end of the compression

Sponsors and collaborators

Lead sponsor

Corporation for the Aid of Burned Children

Other

Collaborators

  • Zimmer Biomet

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2011
Study completion
2012
First posted
Mar 9, 2009
Registry last updated
Feb 13, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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