Burns
Conditions
Keywords
Burn sequelae, PRP, Children
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: 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.
Interventions
PROCEDUREWith 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.
Sponsors
Zimmer Biomet
Corporation for the Aid of Burned Children
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
5 Years to 21 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Median Time Between Surgery Date and Start Date Compression. | day | 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
| Measure | Time frame | Description |
|---|---|---|
| Width of the Graft | start and end compression | Central width measurement graft between the start and the end of the compression |
| Length of the Graft | start and end compression | Central length measurement graft between the start and the end of the compression |
Countries
Chile
Participant flow
Recruitment details
Participants were recruited on the day of the scheduled surgery. The researcher checked the inclusion criteria. Explained to the parents and patient surgical procedure, risk of complications and are invited to participate voluntarily in the study. Informed consent is signed. They recruited 44 children in total between April 6,2009 and August 9,2011
Pre-assignment details
Potential candidates to enter the study were 80. Of these, 20 were excluded for having a weight less than 35 kg; 15 for failing to ensure their attendance at the controls and 1 have coagulation disorders
Participants by arm
| Arm | Count |
|---|---|
| Without PRP Patients with burns sequelae on their limbs treated with release of burns contractures and skin graft between 2008-2010. | 21 |
| With PRP Patients with burns sequelae on their limbs treated with release of burn contractures and skin graft with PRP between 2008-2010. | 23 |
| Total | 44 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Compression:Start to Finish | Lost to Follow-up | 1 | 3 |
Baseline characteristics
| Characteristic | Without PRP | With PRP | Total |
|---|---|---|---|
| Age, Continuous | 14.5 years STANDARD_DEVIATION 3.1 | 14.1 years STANDARD_DEVIATION 3.5 | 14.2 years STANDARD_DEVIATION 3.3 |
| Region of Enrollment Chile | 21 participants | 23 participants | 44 participants |
| Sex: Female, Male Female | 8 Participants | 17 Participants | 25 Participants |
| Sex: Female, Male Male | 13 Participants | 6 Participants | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 21 | 0 / 23 |
| serious Total, serious adverse events | 1 / 21 | 1 / 23 |
Outcome results
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
Time frame: day
Population: A participant may have one, two or three areas grafted
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Without PRP | Median Time Between Surgery Date and Start Date Compression. | 17 day |
| With PRP | Median Time Between Surgery Date and Start Date Compression. | 19 day |
p-value: >0.157495% CI: [-7.332, 2.428]t-test, 1 sided
Secondary
Length of the Graft
Central length measurement graft between the start and the end of the compression
Time frame: start and end compression
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Without PRP | Length of the Graft | 0.2 centimeter |
| With PRP | Length of the Graft | 0.2 centimeter |
p-value: >0.398Wilcoxon (Mann-Whitney)
Secondary
Width of the Graft
Central width measurement graft between the start and the end of the compression
Time frame: start and end compression
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Without PRP | Width of the Graft | 0.1 centimeter |
| With PRP | Width of the Graft | 0.3 centimeter |
p-value: >0.59395% CI: [-1.28561, 0.74189]t-test, 2 sided