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Analysis of Postoperative Bandage Use Protocols in Otoplasty

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ClinicalTrials.gov Identifier: NCT01810497
Recruitment Status : Completed
First Posted : March 13, 2013
Last Update Posted : June 1, 2015
Sponsor:
Information provided by (Responsible Party):
Davi Reis Calderoni, 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.

Condition or disease Intervention/treatment Phase
Prominent Ears Procedure: Use of ear bandage Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Analysis of the Influence of Different Protocols of Postoperative Elastic Bandage Use in the Results of Otoplasty
Study Start Date : May 2012
Actual Primary Completion Date : December 2014
Actual Study Completion Date : March 2015

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.




Primary Outcome Measures :
  1. Incidence of re-operation [ Time Frame: until 12 months ]

Secondary Outcome Measures :
  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 Outcome Measures:
  1. Incidence of hemorrhagic complications [ Time Frame: 1 month ]


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Ages Eligible for Study:   10 Years to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01810497


Locations
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Brazil
Unicamp Hospital
Campinas, São Paulo, Brazil, 13083-887
Sponsors and Collaborators
University of Campinas, Brazil
Investigators
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Principal Investigator: Davi R Calderoni, M.D. Division of Plastic Surgery, Faculty of Medical Sciences, University of Campinas - Unicamp

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Responsible Party: Davi Reis Calderoni, Plastic Surgeon; Division of Plastic Surgery of the Faculty of Medical Sciences, University of Campinas, Brazil
ClinicalTrials.gov Identifier: NCT01810497     History of Changes
Other Study ID Numbers: PLASTICA-001
First Posted: March 13, 2013    Key Record Dates
Last Update Posted: June 1, 2015
Last Verified: May 2015
Keywords provided by Davi Reis Calderoni, University of Campinas, Brazil:
External ear
Ear abnormalities
External ear cartilages