Analysis of Postoperative Bandage Use Protocols in Otoplasty

Not Applicable

Completed

• Conditions: Prominent Ears
• Interventions: Procedure: Use of ear bandage

• Registration Number: NCT01810497
• Lead Sponsor: University of Campinas, Brazil

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-05
• Study First Submitted: 2013-03-10
• Study First Submitted QC: 2013-03-11
• Study First Posted: 2013-03-13
• Primary Completion: 2014-12
• Study Completion: 2015-03
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-28
• Last Update Posted: 2015-06-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Thirty-day bandage use	Use of ear bandage	Patients randomized and instructed to use of ear bandage 24h/day for thirty days after otoplasty
Seven-day bandage use	Use of ear bandage	Patients randomized and instructed to use of ear bandage 24h/day for seven days after otoplasty

Primary Outcome Measures

Name	Time	Method
Incidence of re-operation	until 12 months

Secondary Outcome Measures

Name	Time	Method
Change from immediate postoperative period of helix-mastoid distance	12 months

Trial Locations

Locations (1)

Unicamp Hospital; 🇧🇷 Campinas, São Paulo, Brazil