Platelet-Rich Plasma (PRP) in Reconstructive Surgery on Children With Retractable Burn Sequelae on Extremities

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-31

Study Completion Date

2012-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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?

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Use of Autologous Platelet-Rich Plasma to Treat Hypertrophic Burn Scars

NCT03935594

Hypertrophic Scar

TERMINATED PHASE2

Effect of Platelet Rich Plasma and Keratinocyte Suspensions on Wound Healing

NCT00856934

Skin Graft

COMPLETED PHASE1

Using Autologous Platelet Rich Plasma (PRP) Gel to Treat Deep 2nd and 3rd Degree Burns

NCT01843686

Acute Burns

UNKNOWN PHASE1

Fractional Photothermolysis for the Treatment of Burn Scars

NCT01005992

Scar

UNKNOWN PHASE1

Efficacy of a Fibrin Sealant in Burn Surgery

NCT00181974

Burns

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Burns

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

With PRP

Each patient received a single dose of 5cc PRP before the graft.

Group Type EXPERIMENTAL

With PRP

Intervention Type 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.

Without PRP

Control patients did not receive any intervention before the graft.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

With 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.

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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