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Analysis of Postoperative Bandage Use Protocols in Otoplasty

U

University of Campinas, Brazil

Status

Completed

Conditions

Prominent Ears

Treatments

Procedure: Use of ear bandage

Study type

Interventional

Funder types

Other

Identifiers

NCT01810497
PLASTICA-001

Details and patient eligibility

About

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.

Enrollment

70 patients

Sex

All

Ages

10 to 80 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

70 participants in 2 patient groups

Seven-day bandage use
Active Comparator group
Description:
Patients randomized and instructed to use of ear bandage 24h/day for seven days after otoplasty
Treatment:
Procedure: Use of ear bandage
Thirty-day bandage use
Active Comparator group
Description:
Patients randomized and instructed to use of ear bandage 24h/day for thirty days after otoplasty
Treatment:
Procedure: Use of ear bandage

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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