Platelet-Rich Plasma (PRP) in Reconstructive Surgery on Children With Retractable Burn Sequelae on Extremities
Recruitment status was Recruiting
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?
|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|
- 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 ]
- 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 ]
|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)|
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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00858442
|Contact: M B Quezada, MDfirstname.lastname@example.org|
|Contact: F E Solis, MSemail@example.com|
|Santiago, Pudahuel, Chile|
|Contact: Beatriz Quezada, Doctor 56 2 8734077 firstname.lastname@example.org|
|Contact: Fresia Solis, MS 56 2 8734077 email@example.com|
|Principal Investigator: beatriz Quezada, Doctor|
|Principal Investigator:||M B Quezada, MD||Corporation for the Aid of Burned Children|