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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2009 by Corporation for the Aid of Burned Children.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Biomet, Inc.
Information provided by:
Corporation for the Aid of Burned Children
ClinicalTrials.gov Identifier:
NCT00858442
First received: March 5, 2009
Last updated: June 24, 2011
Last verified: August 2009
  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: PRP in Reconstructive Surgery

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:
  • Measurement of Initiation time of compressive treatment. [ Time Frame: Measurement of Initiation time of compressive treatment, between 12-18 postoperatory days. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Measurement of the long and width of the graft in the initiation and ending of the compressive treatment. A standardized photograph of the grafted area will be taken on ending the surgery, at the initiation and ending of the compressive treatment [ Time Frame: initiation and ending of the compressive treatment. ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 44
Study Start Date: March 2009
Estimated Study Completion Date: August 2012
Estimated Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Platelet Rich Plasma (PRP)
Procedure/Surgery 22 patients, 5 to 18 years old, with burn sequelae on their limbs treated with release of burn contractures and skin graft with PRP during 2008 - 2010.
Procedure: PRP in Reconstructive Surgery
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.

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 18 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 18 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

Contacts
Contact: M B Quezada, MD 56-2-8734077 investigacion@coaniquem.cl
Contact: F E Solis, MS 56-2-8734077 investigacion@coaniquem.cl

Locations
Chile
Coaniquem Recruiting
Santiago, Pudahuel, Chile
Contact: Beatriz Quezada, Doctor    56 2 8734077    investigacion@coaniquem.cl   
Contact: Fresia Solis, MS    56 2 8734077    investigacion@coaniquem.cl   
Principal Investigator: beatriz Quezada, Doctor         
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: Beatriz Quezada and Fresia Solis, COANIQUEM
ClinicalTrials.gov Identifier: NCT00858442     History of Changes
Other Study ID Numbers: 1-Quezada
Study First Received: March 5, 2009
Last Updated: June 24, 2011
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 October 30, 2014