Ear CartilageNCT03215979
Use of Platelet-enriched Plasma During Auricular Reconstruction
A study testing Platelet enriched plasma administration in people with Ear Cartilage and Platelets, run by Hospital General Dr. Manuel Gea González at 1 site in Mexico.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 12 years
- Conditions the study is for
- Ear Cartilage, Platelets, Microtia-Anotia
- What is being tested?
- Platelet enriched plasma administration
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteMexico
- Study dates
- 29 Jun 2017to 10 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 8 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Microtia Tanzer II-A
- patients aged 8-12 years
- Haemoglobin > 10 gr/dL
- History of first stage of auricular reconstruction
Who cannot join
- associated endocrinopathies
- desnutrition (<2.5 gr/ dL)
Trial locations and contacts
1 site in 1 country.
Mexico1 site, 1 recruiting
- Recruiting
Hospital General "Dr. Manuel Gea González"
Mexico City, 4800
Jorge Raúl Carrillo-Córdova, M.D, 01 55 4000 3000 ext. 1323, dr.carrillo.plastica@gmail.com
About this study
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
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
- Ear Cartilage, Platelets, Microtia-Anotia
- Being tested
- Platelet enriched plasma administration, Placebo Arm
- Medical subject headings
- Microtia-Anotia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Platelet enriched plasma administrationProcedure or surgery
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 ArmProcedure or surgery
5 ml of saline 0.9%will be applied in the temporal fascia as a placebo used to compare to the experimental group.
| Study group | Role | What they receive |
|---|---|---|
| PEP-Arm | Experimental | 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. Receives: Procedure: Platelet enriched plasma administration |
| Placebo-Arm | Placebo comparator | This arm will be used as control. The surgeon will inject 0.9% saline solution (5ml) in a blinded basis. Receives: Procedure: Placebo Arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: evaluation will be at day 10
Secondary outcomes (1)
Complication
It refers to a deviation from the normal course of the pathology, 3 complications will be taken into account: infection, seroma and hematoma
Measured: evaluation will be at day 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2017
- Study start29 Jun 2017
- Primary completion29 Nov 2018 (estimated)
- Study completion10 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ear CartilageStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital General Dr. Manuel Gea González
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Jorge Raúl Carrillo Córdova, Hospital General Dr. Manuel Gea González
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03215979
- Sponsor's protocol ID
- 05-20-2017
- Status last verified
- Feb 2018
- First submitted
- 7 Jul 2017
- Last updated
- 22 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03215979
- Acronym / sponsor ID
- 05-20-2017
- Conditions
- Ear Cartilage, Platelets, Microtia-Anotia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Hospital General Dr. Manuel Gea GonzálezOther government
- Study start
- 29 Jun 2017 (actual)
- Primary completion
- 29 Nov 2018 (estimated)
- Study completion
- 10 Dec 2018 (estimated)
- First posted
- 12 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PEP-Arm | Experimental | Procedure: Platelet enriched plasma administrationIn 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. |
| Placebo-Arm | Placebo comparator | Procedure: Placebo ArmThis arm will be used as control. The surgeon will inject 0.9% saline solution (5ml) in a blinded basis. |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Microtia Tanzer II-A
- patients aged 8-12 years
- Haemoglobin > 10 gr/dL
- History of first stage of auricular reconstruction
Key exclusion criteria (2 listed)
- associated endocrinopathies
- desnutrition (<2.5 gr/ dL)
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 |
|---|---|---|
| Platelet enriched plasma administrationIt 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 | Procedure or surgery | PEP-Arm |
| Placebo Arm5 ml of saline 0.9%will be applied in the temporal fascia as a placebo used to compare to the experimental group. | Procedure or surgery | Placebo-Arm |
Primary outcome
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.
1 secondary outcome
Complication
Time frame: evaluation will be at day 10
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2018.
- Individual participant dataSharing planned: No
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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.
Hospital General "Dr. Manuel Gea González"
Mexico City, Mexico
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Platelet enriched plasma administration in people with Ear Cartilage and Platelets, run by Hospital General Dr. Manuel Gea González at 1 site in Mexico.
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 4 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: status not confirmed, as of the sponsor's last update on 22 Feb 2018. 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 Mexico. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Feb 2018.