Prominent EarsNCT01810497
Analysis of Postoperative Bandage Use Protocols in Otoplasty
A study testing Use of ear bandage in people with Prominent Ears, run by University of Campinas, Brazil at 1 site in Brazil.
Trial summary
The aim of the study is to investigate the possible influence of different durations of use of postoperative elastic bandaging (seven days vs. thirty days) in the results of otoplasty. Read more about this study
- Who is it for?
- Ages 10 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Prominent Ears
- What is being tested?
- Use of ear bandage
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteBrazil
- Study dates
- May 2012to Mar 2015
- 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 10 to 80 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Congenital bilateral ear prominence
- 10 years-old or older
- No previous attempt of surgical treatment
Who cannot join
- Pregnant women
- Breastfeeding women
- Blod clotting disorders or current anticoagulant use
- Uncontrolled systemic diseases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Analysis of the Influence of Different Protocols of Postoperative Elastic Bandage Use in the Results of Otoplasty
The aim of the study is to investigate the possible influence of different durations of use of postoperative elastic bandaging (seven days vs. thirty days) in the results of otoplasty. We hypothesize that the duration of elastic bandage use has no significant influence on the incidence of relapse of prominence of the ears and need for reoperation.
- Conditions
- Prominent Ears
- Being tested
- Use of ear bandage
- Keywords
- External ear, Ear abnormalities, External ear cartilages
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Use of ear bandageProcedure or surgery
Elastic bandage to be used on the postoperative period of otoplasty, starting immediately after the procedure. To be used 24hours/day for the specified period.
| Study group | Role | What they receive |
|---|---|---|
| Seven-day bandage use | Active comparator | Patients randomized and instructed to use of ear bandage 24h/day for seven days after otoplasty Receives: Procedure: Use of ear bandage |
| Thirty-day bandage use | Active comparator | Patients randomized and instructed to use of ear bandage 24h/day for thirty days after otoplasty Receives: Procedure: Use of ear bandage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of re-operation
Measured: until 12 months
Secondary outcomes (2)
Change from immediate postoperative period of helix-mastoid distance
Measured: 6 months
Change from immediate postoperative period of helix-mastoid distance
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2013 (estimated)
- Study startMay 2012
- Primary completionDec 2014
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prominent EarsStudies 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
- Care provider, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Campinas, Brazil
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Davi Reis Calderoni, University of Campinas, Brazil
- Investigators
- Davi R Calderoni, M.D., Principal investigator, Division of Plastic Surgery, Faculty of Medical Sciences, University of Campinas - Unicamp
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01810497
- Sponsor's protocol ID
- PLASTICA-001
- Status last verified
- May 2015
- First submitted
- 10 Mar 2013
- Last updated
- 1 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of the Influence of Different Protocols of Postoperative Elastic Bandage Use in the Results of Otoplasty
- ClinicalTrials.gov ID
- NCT01810497
- Acronym / sponsor ID
- PLASTICA-001
- Conditions
- Prominent Ears
- Keywords
- External ear, Ear abnormalities, External ear cartilages
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- University of Campinas, BrazilUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- Dec 2014 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 13 Mar 2013 (estimated)
- 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.
The aim of the study is to investigate the possible influence of different durations of use of postoperative elastic bandaging (seven days vs. thirty days) in the results of otoplasty. We hypothesize that the duration of elastic bandage use has no significant influence on the incidence of relapse of prominence of the ears and need for reoperation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Seven-day bandage use | Active comparator | Procedure: Use of ear bandagePatients randomized and instructed to use of ear bandage 24h/day for seven days after otoplasty |
| Thirty-day bandage use | Active comparator | Procedure: Use of ear bandagePatients randomized and instructed to use of ear bandage 24h/day for thirty days after otoplasty |
Who may qualify
- Ages
- 10 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Congenital bilateral ear prominence
- 10 years-old or older
- No previous attempt of surgical treatment
Key exclusion criteria (4 listed)
- Pregnant women
- Breastfeeding women
- Blod clotting disorders or current anticoagulant use
- Uncontrolled systemic diseases
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 |
|---|---|---|
| Use of ear bandageElastic bandage to be used on the postoperative period of otoplasty, starting immediately after the procedure. To be used 24hours/day for the specified period. | Procedure or surgery | Seven-day bandage use, Thirty-day bandage use |
Primary outcome
Incidence of re-operation
Time frame: until 12 months
2 secondary outcomes
Change from immediate postoperative period of helix-mastoid distance
Time frame: 6 months
Change from immediate postoperative period of helix-mastoid distance
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2015.
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.
Davi R Calderoni, M.D. principal investigator
Division of Plastic Surgery, Faculty of Medical Sciences, University of Campinas - Unicamp
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Use of ear bandage in people with Prominent Ears, run by University of Campinas, Brazil at 1 site in Brazil.
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 3 inclusion and 4 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: finished, as of the sponsor's last update on 1 Jun 2015. 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 Brazil. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of re-operation (time frame: until 12 months). 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 1 Jun 2015.