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CompletedNCT01810497Updated Jun 1, 2015

Analysis of Postoperative Bandage Use Protocols in Otoplasty

An interventional study of Use of ear bandage in Prominent Ears, sponsored by University of Campinas, Brazil. Completed at 1 site in Brazil. Open to participants aged 10 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-06-01.

Sponsored by University of Campinas, Brazil · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
70
Allocation
Randomized
Ages
10 Years to 80 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Prominent Ears

Keywords

  • External ear
  • Ear abnormalities
  • External ear cartilages
03

In context

Lead sponsor

University of Campinas, Brazil is the lead sponsor of 166 studies on the registry; 13 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
10 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Congenital bilateral ear prominence
  • 10 years-old or older
  • No previous attempt of surgical treatment

Exclusion criteria

Exclusion Criteria:

  • Pregnant women
  • Breastfeeding women
  • Blod clotting disorders or current anticoagulant use
  • Uncontrolled systemic diseases
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Care provider, Outcomes assessor)
Enrollment
70 participants (actual)

Study arms

  • Active comparator
    Seven-day bandage use

    Patients randomized and instructed to use of ear bandage 24h/day for seven days after otoplasty

    Procedure: Use of ear bandage

  • Active comparator
    Thirty-day bandage use

    Patients randomized and instructed to use of ear bandage 24h/day for thirty days after otoplasty

    Procedure: Use of ear bandage

Interventions

  • ProcedureUse of ear bandage

    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.

06

What researchers measure

Primary outcomes

  1. Incidence of re-operation

    Time frame: until 12 months

Secondary outcomes

  1. Change from immediate postoperative period of helix-mastoid distance

    Time frame: 6 months

  2. Change from immediate postoperative period of helix-mastoid distance

    Time frame: 12 months

Other outcomes

  1. Incidence of hemorrhagic complications

    Time frame: 1 month

07

Study locations

1 site
  • Unicamp Hospital
    Campinas, São Paulo 13083-887, Brazil
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 1, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01810497
Lead sponsor
University of Campinas, Brazil
Responsible party
Davi Reis Calderoni (Plastic Surgeon; Division of Plastic Surgery of the Faculty of Medical Sciences, University of Campinas, Brazil) — Principal investigator
First posted
Mar 13, 2013
Start date
May 2012
Primary completion
Dec 2014
Completion
Mar 2015
Last update
Jun 1, 2015

Study contacts

Davi R Calderoni, M.D.
principal investigator · Division of Plastic Surgery, Faculty of Medical Sciences, University of Campinas - Unicamp

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2015. You cannot join it, but the record below documents what was studied.

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