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
Recruitment status was Recruiting
Sponsor:
Corporation for the Aid of Burned Children
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
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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:
- 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.
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
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 May 21, 2013