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OpenTrials
Completed

NCT Number: NCT01810497

Analysis of Postoperative Bandage Use Protocols in 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.

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Key information

Conditions

Prominent Ears

Age range

10 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Unicamp Hospital

Campinas, São Paulo, 13083-887, Brazil

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Use of ear bandage

Procedure

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.

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

Sponsors and collaborators

Lead sponsor

University of Campinas, Brazil

Other

Registry information

Official study title

Analysis of the Influence of Different Protocols of Postoperative Elastic Bandage Use in the Results of Otoplasty

Important dates

Study start
2012
Primary completion
2014
Study completion
2015
First posted
Mar 13, 2013
Registry last updated
Jun 1, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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