Analysis of Postoperative Bandage Use Protocols in Otoplasty

May 28, 2015 updated by: Davi Reis Calderoni, University of Campinas, Brazil

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • São Paulo
      • Campinas, São Paulo, Brazil, 13083-887
        • Unicamp Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 80 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
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.
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of re-operation
Time Frame: until 12 months
until 12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Change from immediate postoperative period of helix-mastoid distance
Time Frame: 6 months
6 months
Change from immediate postoperative period of helix-mastoid distance
Time Frame: 12 months
12 months

Other Outcome Measures

Outcome Measure
Time Frame
Incidence of hemorrhagic complications
Time Frame: 1 month
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Campinas, Brazil

Investigators

  • Principal Investigator: Davi R Calderoni, M.D., Division of Plastic Surgery, Faculty of Medical Sciences, University of Campinas - Unicamp

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2012

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

March 1, 2015

Study Registration Dates

First Submitted

March 10, 2013

First Submitted That Met QC Criteria

March 11, 2013

First Posted (Estimate)

March 13, 2013

Study Record Updates

Last Update Posted (Estimate)

June 1, 2015

Last Update Submitted That Met QC Criteria

May 28, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • PLASTICA-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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