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

NCT00858442 | Completed Results

• 1 other identifier: 1-Quezada
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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?

Conditions

Burns

Keywords

Burn sequelae; PRP; Children

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Width of the Graft

  start and end compression

• Length of the Graft

  start and end compression

Study Arms (2)

With PRP

EXPERIMENTAL

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

Procedure: With PRP

Without PRP

NO INTERVENTION

Control patients did not receive any intervention before the graft.

Interventions

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.

With PRP

Eligibility Criteria

• Age: 5 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Background of blood alterations
• Another current pathology

Sponsors & Collaborators

• Corporation for the Aid of Burned Children: lead
• Zimmer Biomet: collaborator

Study Sites (1)

Coaniquem

Santiago, Pudahuel, Chile

Location

Related Publications (6)

• 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.

  PMID: 18954394 RESULT

• 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.

  PMID: 18390240 RESULT

• 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.

  PMID: 18318807 RESULT

• 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.

  PMID: 18204746 RESULT

• 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.

  PMID: 15062754 RESULT

• 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.

  PMID: 18703188 RESULT

Related Links

• burns scars

MeSH Terms

Conditions

Burns

Condition Hierarchy (Ancestors)

Wounds and Injuries

Limitations and Caveats

Loss cases: PRP group: 3/23 and group without PRP: 1/21

Results Point of Contact

• Title: M Beatriz Quezada.MD
• Organization: coaniquem

investigacion@coaniquem.cl

56-2-28734077

Study Officials

• M B Quezada, MD

  Corporation for the Aid of Burned Children

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: md

Study Record Dates

• First Submitted: March 5, 2009
• First Posted: March 9, 2009
• Study Start: March 1, 2009
• Primary Completion: October 1, 2011
• Study Completion: November 1, 2012
• Last Updated: February 13, 2015
• Results First Posted: January 26, 2015

Record last verified: 2015-01

Locations

CL (1)