search
Back to results

Use of Platelet-enriched Plasma During Auricular Reconstruction

Primary Purpose

Ear Cartilage, Platelets, Microtia-Anotia

Status
Unknown status
Phase
Not Applicable
Locations
Mexico
Study Type
Interventional
Intervention
Platelet enriched plasma administration
Placebo Arm
Sponsored by
Hospital General Dr. Manuel Gea González
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ear Cartilage

Eligibility Criteria

8 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Hospital General "Dr. Manuel Gea González"Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

PEP-Arm

Placebo-Arm

Arm Description

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.

This arm will be used as control. The surgeon will inject 0.9% saline solution (5ml) in a blinded basis.

Outcomes

Primary Outcome Measures

Integration rate (in percentage) of the full thickness split graft sued during the second stage of auricular reconstruction.
Evaluation of the integration will be made on clinical basis, and evaluated by 3 experimented plastic surgeons.

Secondary Outcome Measures

Complication
It refers to a deviation from the normal course of the pathology, 3 complications will be taken into account: infection, seroma and hematoma

Full Information

First Posted
July 7, 2017
Last Updated
February 20, 2018
Sponsor
Hospital General Dr. Manuel Gea González
search

1. Study Identification

Unique Protocol Identification Number
NCT03215979
Brief Title
Use of Platelet-enriched Plasma During Auricular Reconstruction
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Unknown status
Study Start Date
June 29, 2017 (Actual)
Primary Completion Date
November 29, 2018 (Anticipated)
Study Completion Date
December 10, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital General Dr. Manuel Gea González

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ear Cartilage, Platelets, Microtia-Anotia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PEP-Arm
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo-Arm
Arm Type
Placebo Comparator
Arm Description
This arm will be used as control. The surgeon will inject 0.9% saline solution (5ml) in a blinded basis.
Intervention Type
Procedure
Intervention Name(s)
Platelet enriched plasma administration
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
Placebo Arm
Intervention Description
5 ml of saline 0.9%will be applied in the temporal fascia as a placebo used to compare to the experimental group.
Primary Outcome Measure Information:
Title
Integration rate (in percentage) of the full thickness split graft sued during the second stage of auricular reconstruction.
Description
Evaluation of the integration will be made on clinical basis, and evaluated by 3 experimented plastic surgeons.
Time Frame
evaluation will be at day 10
Secondary Outcome Measure Information:
Title
Complication
Description
It refers to a deviation from the normal course of the pathology, 3 complications will be taken into account: infection, seroma and hematoma
Time Frame
evaluation will be at day 10

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Facility Information:
Facility Name
Hospital General "Dr. Manuel Gea González"
City
Mexico city
ZIP/Postal Code
4800
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jorge Raúl Carrillo-Córdova, M.D
Phone
01 55 4000 3000
Ext
1323
Email
dr.carrillo.plastica@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Use of Platelet-enriched Plasma During Auricular Reconstruction

We'll reach out to this number within 24 hrs