- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03215979
Use of Platelet-enriched Plasma During Auricular Reconstruction
February 20, 2018 updated by: Jorge Raúl Carrillo Córdova, Hospital General Dr. Manuel Gea González
Use of Platelet-enriched Plasma to Improve the Percentage of Integration of the Cutaneous Graft During Second Stage of Auricular Reconstruction in Children Aged 8-12 Years; A Controlled Clinical Trial
In this study investigators are trying to determine the benefits of using platelet enriched plasma during the second stage of auricular reconstruction.
The intervention will be blinded to the surgeon and the surgical team.
The main outcome will be the evaluation of the integration rate of the skin full thickness graft used to coat the auricular frame.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
36
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Mexico city, Mexico, 4800
- Recruiting
- Hospital General "Dr. Manuel Gea González"
-
Contact:
- Jorge Raúl Carrillo-Córdova, M.D
- Phone Number: 1323 01 55 4000 3000
- Email: dr.carrillo.plastica@gmail.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
8 years to 12 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Microtia Tanzer II-A
- patients aged 8-12 years
- Haemoglobin > 10 gr/dL
- History of first stage of auricular reconstruction
Exclusion Criteria:
- associated endocrinopathies
- desnutrition (<2.5 gr/ dL)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: PEP-Arm
In this arm, surgeon will be applying platelet enriched plasma(PEP) (5 ml) during the second stage procedure of auricular reconstruction.
PEP will be infected in the temporal fascia used to cover the cartilage frame.
|
It is a blinded administration of platelet enriched plasma in the temporal fascia used to cover the auricular reconstruction frame, during the second stage of the procedure.
The use of platelet enriched plasma is focused to improve the integration rate of the full-thickness split skin graft
|
Placebo Comparator: Placebo-Arm
This arm will be used as control.
The surgeon will inject 0.9% saline solution (5ml) in a blinded basis.
|
5 ml of saline 0.9%will be applied in the temporal fascia as a placebo used to compare to the experimental group.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Integration rate (in percentage) of the full thickness split graft sued during the second stage of auricular reconstruction.
Time Frame: evaluation will be at day 10
|
Evaluation of the integration will be made on clinical basis, and evaluated by 3 experimented plastic surgeons.
|
evaluation will be at day 10
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Complication
Time Frame: evaluation will be at day 10
|
It refers to a deviation from the normal course of the pathology, 3 complications will be taken into account: infection, seroma and hematoma
|
evaluation will be at day 10
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 29, 2017
Primary Completion (Anticipated)
November 29, 2018
Study Completion (Anticipated)
December 10, 2018
Study Registration Dates
First Submitted
July 7, 2017
First Submitted That Met QC Criteria
July 11, 2017
First Posted (Actual)
July 12, 2017
Study Record Updates
Last Update Posted (Actual)
February 22, 2018
Last Update Submitted That Met QC Criteria
February 20, 2018
Last Verified
February 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 05-20-2017
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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