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

Burns Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00858442
• Other study ID #: 1-Quezada
• Status: Completed
• Phase: N/A
• First received: March 5, 2009
• Last updated: January 28, 2015
• Start date: March 2009
• Est. completion date: November 2012

Study information

• Verified date: January 2015
• Source: Corporation for the Aid of Burned Children
• Contact: n/a
• Is FDA regulated: No
• Health authority: Chile: Comisión Nacional de Investigación Científica y Tecnológica
• Study type: Interventional

Clinical Trial 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?

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: November 2012
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 5 Years to 21 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Burns

Intervention

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.

Locations

Country	Name	City	State
Chile	Coaniquem	Santiago	Pudahuel

Sponsors (2)

Lead Sponsor	Collaborator
Corporation for the Aid of Burned Children	Biomet, Inc.

Country where clinical trial is conducted

Chile, 

References & Publications (6)

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. — View 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. — View Citation

Martínez-Zapata MJ, Martí-Carvajal A, Solà I, Bolibar I, Angel Expósito J, Rodriguez L, García 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: 1 — View 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 Repa — View 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. Review. — View 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	day	No
Secondary	Width of the Graft	Central width measurement graft between the start and the end of the compression	start and end compression	No
Secondary	Length of the Graft	Central length measurement graft between the start and the end of the compression	start and end compression	No

External Links

•   burns scars