BurnsNCT00858442
Platelet-Rich Plasma (PRP) in Reconstructive Surgery on Children With Retractable Burn Sequelae on Extremities
A study testing With PRP in people with Burns, run by Corporation for the Aid of Burned Children at 1 site in Chile.
Trial 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? Read more about this study
- Who is it for?
- Ages 5 to 21 years
- Conditions the study is for
- Burns
- What is being tested?
- With PRP
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteChile
- Study dates
- Mar 2009to Nov 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Show all 9Show fewer
- Blood count
- Hepatic and coagulation tests
- Paediatric evaluation prior to surgery
Who cannot join
- Background of blood alterations
- Another current pathology
Trial locations and contacts
1 site in 1 country.
About this study
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
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?
Read the 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.
- Conditions
- Burns
- Being tested
- With PRP
- Keywords
- Burn sequelae, PRP, Children
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
With PRPProcedure or 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.
| Study group | Role | What they receive |
|---|---|---|
| With PRP | Experimental | Each patient received a single dose of 5cc PRP before the graft. Receives: Procedure: With PRP |
| Without PRP | No intervention | Control patients did not receive any intervention before the graft. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: day
Secondary outcomes (2)
Width of the Graft
Central width measurement graft between the start and the end of the compression
Measured: start and end compression
Length of the Graft
Central length measurement graft between the start and the end of the compression
Measured: start and end compression
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2009 (estimated)
- Study startMar 2009
- Primary completionOct 2011
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for BurnsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corporation for the Aid of Burned Children
- Sponsor type
- University, hospital or other
- Collaborators
- Zimmer Biomet
- Responsible party
- Principal investigator, maría beatriz quezada, Corporation for the Aid of Burned Children
- Investigators
- M B Quezada, MD, Principal investigator, Corporation for the Aid of Burned Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00858442
- Sponsor's protocol ID
- 1-Quezada
- Status last verified
- Jan 2015
- First submitted
- 5 Mar 2009
- Last updated
- 13 Feb 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 18954394Rutkowski 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.
PubMed 18390240Pietramaggiori 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.
PubMed 18318807Rozman 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.
PubMed 18204746Crovetti 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.
PubMed 15062754Kazakos 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.
PubMed 18703188
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00858442
- Acronym / sponsor ID
- 1-Quezada
- Conditions
- Burns
- Keywords
- Burn sequelae, PRP, Children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Corporation for the Aid of Burned ChildrenUniversity, hospital or other
- Collaborators
- Zimmer Biomet
- Study start
- Mar 2009
- Primary completion
- Oct 2011 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 9 Mar 2009 (estimated)
- Results
- Posted 26 Jan 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| With PRP | Experimental | Procedure: With PRPEach 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. |
Who may qualify
- Ages
- 5 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (2 listed)
- Background of blood alterations
- Another current pathology
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| With PRPRelease 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. | Procedure or surgery | With PRP |
Primary outcome
Median Time Between Surgery Date and Start Date Compression.
Time frame: 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
2 secondary outcomes
Width of the Graft
Time frame: start and end compression
Length of the Graft
Time frame: start and end compression
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 18954394Martinez-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.
- Results publication: PubMed 18390240Rutkowski 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.
- Results publication: PubMed 18318807Pietramaggiori 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.
- Results publication: PubMed 18204746Rozman 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.
- Results publication: PubMed 15062754Crovetti 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.
- Results publication: PubMed 18703188Kazakos 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.
- burns scarsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
M B Quezada, MD principal investigator
Corporation for the Aid of Burned Children
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing With PRP in people with Burns, run by Corporation for the Aid of Burned Children at 1 site in Chile.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Jan 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Median Time Between Surgery Date and Start Date Compression. (time frame: day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00858442, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2015.