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

Primary Purpose

Burns

Status
Completed
Phase
Not Applicable
Locations
Chile
Study Type
Interventional
Intervention
With PRP
Sponsored by
Corporation for the Aid of Burned Children
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Burns focused on measuring Burn sequelae, PRP, Children

Eligibility Criteria

5 Years - 21 Years (Child, Adult)All SexesDoes not accept 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

Sites / Locations

  • Coaniquem

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

With PRP

Without PRP

Arm Description

Each patient received a single dose of 5cc PRP before the graft.

Control patients did not receive any intervention before the graft.

Outcomes

Primary Outcome Measures

Median Time Between Surgery Date and Start Date Compression.
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
Central width measurement graft between the start and the end of the compression
Length of the Graft
Central length measurement graft between the start and the end of the compression

Full Information

First Posted
March 5, 2009
Last Updated
January 28, 2015
Sponsor
Corporation for the Aid of Burned Children
Collaborators
Zimmer Biomet
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1. Study Identification

Unique Protocol Identification Number
NCT00858442
Brief Title
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

2. Study Status

Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
March 2009 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
November 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Corporation for the Aid of Burned Children
Collaborators
Zimmer Biomet

4. Oversight

Data Monitoring Committee
No

5. Study Description

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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Burns
Keywords
Burn sequelae, PRP, Children

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
With PRP
Arm Type
Experimental
Arm Description
Each patient received a single dose of 5cc PRP before the graft.
Arm Title
Without PRP
Arm Type
No Intervention
Arm Description
Control patients did not receive any intervention before the graft.
Intervention Type
Procedure
Intervention Name(s)
With PRP
Intervention Description
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 Outcome Measure Information:
Title
Median Time Between Surgery Date and Start Date Compression.
Description
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
Time Frame
day
Secondary Outcome Measure Information:
Title
Width of the Graft
Description
Central width measurement graft between the start and the end of the compression
Time Frame
start and end compression
Title
Length of the Graft
Description
Central length measurement graft between the start and the end of the compression
Time Frame
start and end compression

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
M B Quezada, MD
Organizational Affiliation
Corporation for the Aid of Burned Children
Official's Role
Principal Investigator
Facility Information:
Facility Name
Coaniquem
City
Santiago
State/Province
Pudahuel
Country
Chile

12. IPD Sharing Statement

Citations:
PubMed Identifier
18954394
Citation
Martinez-Zapata MJ, Marti-Carvajal A, Sola I, Bolibar I, Angel Exposito J, Rodriguez L, Garcia J. Efficacy and safety of the use of autologous plasma rich in platelets for tissue regeneration: a systematic review. Transfusion. 2009 Jan;49(1):44-56. doi: 10.1111/j.1537-2995.2008.01945.x. Epub 2008 Oct 14.
Results Reference
result
PubMed Identifier
18390240
Citation
Rutkowski JL, Thomas JM, Bering CL, Speicher JL, Radio NM, Smith DM, Johnson DA. Analysis of a rapid, simple, and inexpensive technique used to obtain platelet-rich plasma for use in clinical practice. J Oral Implantol. 2008;34(1):25-33. doi: 10.1563/1548-1336(2008)34[25:AAOARS]2.0.CO;2.
Results Reference
result
PubMed Identifier
18318807
Citation
Pietramaggiori G, Scherer SS, Mathews JC, Alperovich M, Yang HJ, Neuwalder J, Czeczuga JM, Chan RK, Wagner CT, Orgill DP. Healing modulation induced by freeze-dried platelet-rich plasma and micronized allogenic dermis in a diabetic wound model. Wound Repair Regen. 2008 Mar-Apr;16(2):218-25. doi: 10.1111/j.1524-475X.2008.00362.x.
Results Reference
result
PubMed Identifier
18204746
Citation
Rozman P, Bolta Z. Use of platelet growth factors in treating wounds and soft-tissue injuries. Acta Dermatovenerol Alp Pannonica Adriat. 2007 Dec;16(4):156-65.
Results Reference
result
PubMed Identifier
15062754
Citation
Crovetti G, Martinelli G, Issi M, Barone M, Guizzardi M, Campanati B, Moroni M, Carabelli A. Platelet gel for healing cutaneous chronic wounds. Transfus Apher Sci. 2004 Apr;30(2):145-51. doi: 10.1016/j.transci.2004.01.004.
Results Reference
result
PubMed Identifier
18703188
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.
Results Reference
result
Links:
URL
http://www.nlm.nih.gov/medlineplus/
Description
burns scars

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

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