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| Name | Class |
|---|---|
| Zimmer Biomet | INDUSTRY |
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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?
Hypothesis:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| With PRP | Experimental | Each patient received a single dose of 5cc PRP before the graft. |
|
| Without PRP | No Intervention | Control patients did not receive any intervention before the graft. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Width of the Graft | Central width measurement graft between the start and the end of the compression | start and end compression |
| Length of the Graft | Central length measurement graft between the start and the end of the compression |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| M B Quezada, MD | Corporation for the Aid of Burned Children | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Coaniquem | Santiago | Pudahuel | Chile |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18954394 | Result | 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. | |
| 18390240 | Result |
| Label | URL |
|---|---|
| burns scars | View source |
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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 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
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| ID | Title | Description |
|---|---|---|
| FG000 | Without PRP | This arm did not receive any intervention |
| FG001 | With PRP | 4 cc of PRP is evenly distributed before the dermo-epidermic draft. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| From Surgery to Start Compression; |
| |||||||||||||
| Compression:Start to Finish |
|
Some patients received more than one graft, as it is shown in result section.
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| ID | Title | Description |
|---|---|---|
| BG000 | Without PRP | Patients with burns sequelae on their limbs treated with release of burns contractures and skin graft between 2008-2010. |
| BG001 | With PRP | Patients with burns sequelae on their limbs treated with release of burn contractures and skin graft with PRP between 2008-2010. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | A participant may have one, two or three areas grafted | Posted | Median | Full Range | day | day | grafted area | Participants |
|
2 months
adverse effect is considered the need regrafting bloody small areas.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Without PRP | Patients did not receive plasma enriched platelets |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| regrafting | Surgical and medical procedures | Systematic Assessment | adverse effect is considered the need regrafting bloody small areas |
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Loss cases: PRP group: 3/23 and group without PRP: 1/21
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| M Beatriz Quezada.MD | coaniquem | 56-2-28734077 | investigacion@coaniquem.cl |
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| ID | Term |
|---|---|
| D002056 | Burns |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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|
| start and end compression |
| 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. |
| 18318807 | 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. |
| 18204746 | 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. |
| 15062754 | 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. |
| 18703188 | 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. |
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|
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
| grafted area |
|
|
|
| Secondary | Width of the Graft | Central width measurement graft between the start and the end of the compression | Posted | Median | Inter-Quartile Range | centimeter | start and end compression | grafted areas | Participants |
|
|
|
|
| Secondary | Length of the Graft | Central length measurement graft between the start and the end of the compression | Posted | Median | Inter-Quartile Range | centimeter | start and end compression | grafted areas | Participants |
|
|
|
|
| 1 |
| 21 |
| 0 |
| 21 |
| EG001 | With PRP | Patients received plasma enriched platelets | 1 | 23 | 0 | 23 |
|
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