## Protocol Section
### Identification Module
**NCT ID:** 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

#### Organization Study ID Info
**ID:** 05-20-2017
#### Organization
**Class:** OTHER_GOV
**Full Name:** Hospital General Dr. Manuel Gea González
### Status Module
#### Completion Date
**Date:** 2018-12-10

**Type:** ESTIMATED

#### Expanded Access Info
**Last Known Status:** RECRUITING
#### Last Update Post Date
**Date:** 2018-02-22

**Type:** ACTUAL

**Last Update Submit Date:** 2018-02-20

**Overall Status:** UNKNOWN

#### Primary Completion Date
**Date:** 2018-11-29

**Type:** ESTIMATED

#### Start Date
**Date:** 2017-06-29

**Type:** ACTUAL

**Status Verified Date:** 2018-02

#### Study First Post Date
**Date:** 2017-07-12
**Type:** ACTUAL
**Study First Submit Date:** 2017-07-07
**Study First Submit QC Date:** 2017-07-11
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER_GOV

**Name:** Hospital General Dr. Manuel Gea González

#### Responsible Party

**Investigator Affiliation:** Hospital General Dr. Manuel Gea González

**Investigator Full Name:** Jorge Raúl Carrillo Córdova

**Investigator Title:** Medical Doctor

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Ear Cartilage

- Platelets

- Microtia-Anotia

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** DOUBLE

**Who Masked:**

- PARTICIPANT

- INVESTIGATOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 36

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**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.

**Intervention Names:**

- Procedure: Platelet enriched plasma administration

**Label:** PEP-Arm

**Type:** EXPERIMENTAL

#### Arm Group 2

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

**Intervention Names:**

- Procedure: Placebo Arm

**Label:** Placebo-Arm

**Type:** PLACEBO_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- PEP-Arm

**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

**Name:** Platelet enriched plasma administration

**Type:** PROCEDURE

#### Intervention 2

**Arm Group Labels:**

- Placebo-Arm

**Description:** 5 ml of saline 0.9%will be applied in the temporal fascia as a placebo used to compare to the experimental group.

**Name:** Placebo Arm

**Type:** PROCEDURE

### Outcomes Module

#### Primary Outcomes

**Description:** Evaluation of the integration will be made on clinical basis, and evaluated by 3 experimented plastic surgeons.

**Measure:** 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

#### Secondary Outcomes

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

**Measure:** Complication

**Time Frame:** evaluation will be at day 10

### Eligibility Module

**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)

**Maximum Age:** 12 Years

**Minimum Age:** 8 Years

**Sex:** ALL

**Standard Ages:**

- CHILD

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Mexico city

**Contacts:**

***Contact 1:***

- **Email:** dr.carrillo.plastica@gmail.com

- **Name:** Jorge Raúl Carrillo-Córdova, M.D

- **Phone:** 01 55 4000 3000

- **Phone Ext:** 1323

- **Role:** CONTACT

**Country:** Mexico

**Facility:** Hospital General "Dr. Manuel Gea González"

**Status:** RECRUITING

**Zip:** 4800

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000004427

- Term: Ear Diseases

- ID: D000010038

- Term: Otorhinolaryngologic Diseases

- ID: D000000013

- Term: Congenital Abnormalities

### Condition Browse Module - Browse Branches

- Abbrev: BC09

- Name: Ear, Nose, and Throat Diseases

- Abbrev: BC16

- Name: Diseases and Abnormalities at or Before Birth

- Abbrev: All

- Name: All Conditions

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M30605

- Name: Congenital Microtia

- Relevance: HIGH

- As Found: Microtia

- ID: M7601

- Name: Ear Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12961

- Name: Otorhinolaryngologic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12

- Name: Congenital Abnormalities

- Relevance: LOW

- As Found: Unknown

- ID: T3813

- Name: Microtia-Anotia

- Relevance: HIGH

- As Found: Microtia-Anotia

### Condition Browse Module - Meshes

- ID: D000065817

- Term: Congenital Microtia

### Intervention Browse Module - Browse Branches

- Abbrev: PhSol

- Name: Pharmaceutical Solutions

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M21860

- Name: Pharmaceutical Solutions

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24
