Analysis of Postoperative Bandage Use Protocols in Otoplasty

Prominent Ears Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01810497
• Other study ID #: PLASTICA-001
• Status: Completed
• Phase: N/A
• First received: March 10, 2013
• Last updated: May 28, 2015
• Start date: May 2012
• Est. completion date: March 2015

Study information

• Verified date: May 2015
• Source: University of Campinas, Brazil
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: March 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 10 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prominent Ears

Intervention

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.

Locations

Country	Name	City	State
Brazil	Unicamp Hospital	Campinas	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Campinas, Brazil

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Incidence of hemorrhagic complications		1 month	No
Primary	Incidence of re-operation		until 12 months	No
Secondary	Change from immediate postoperative period of helix-mastoid distance		6 months	No
Secondary	Change from immediate postoperative period of helix-mastoid distance		12 months	No