Dressing Wear Time After Reduction Mammaplasty

September 3, 2019 updated by: Daniela Francescato Veiga

Twenty-four Hours or 6 Days? A Prospective Randomized Trial Comparing Dressing Wear Time After Reduction Mammaplasty

This study was designed to determine whether the duration of dressing wear following reduction mammaplasty influence skin colonization and surgical site infections rates.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Surgical site infections (SSI) are wound infections that occur after invasive procedures.Particularly in plastic surgery procedures, to minimize the risk of SSI is imperative, since even minor infections are able to complicate the healing process and harm the cosmetic result.

Reduction mammaplasty is an effective and well established procedure performed for the relief of physical pain and discomfort associated with macromastia, which significantly decreases patients' quality of life.Breast reduction has provided long-term relief for most patients, with high patient satisfaction.

The demand for this kind of plastic surgery is high.Reduction mammaplasty was the fifth most commonly surgical procedure performed by plastic surgeons in women of United States.Since reduction mammaplasty is associated with a high incidence of wound problems,all effort to minimize the risk of SSI is valid.

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
    • Minas Gerais
      • Pouso Alegre, Minas Gerais, Brazil, 37550000
        • Hospital das Clínicas Samuel Libânio - UNIVÁS

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

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • breast hypertrophy
  • candidate to reduction mammaplasty
  • body mass index under 30Kg/m2

Exclusion Criteria:

  • pregnancy, delivery or breast feeding during the last 12 months
  • body mass index over 30Kg/m2
  • breast cancer history
  • previous breast surgery
  • hard smoking

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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Postoperative day 1
Dressing is removed on the first postoperative day
Procedure: reduction mammaplasty
Dressing following reduction mammaplasty is removed on the first postoperative day
Other Names:
  • Breast reduction surgery
Procedure: reduction mammaplasty
Dressing following reduction mammaplasty is removed on the sixth postoperative day
Other Names:
  • Breast reduction surgery
Experimental: Postoperative day 6
Dressing is removed on the sixth postoperative day
Procedure: reduction mammaplasty
Dressing following reduction mammaplasty is removed on the first postoperative day
Other Names:
  • Breast reduction surgery
Procedure: reduction mammaplasty
Dressing following reduction mammaplasty is removed on the sixth postoperative day
Other Names:
  • Breast reduction surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
surgical site infection
Time Frame: 30 days postoperatively
30 days postoperatively

Secondary Outcome Measures

Outcome Measure
Time Frame
skin colonization
Time Frame: 6 days postoperatively
6 days postoperatively

Collaborators and Investigators

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

Sponsor

Daniela Francescato Veiga

Collaborators

Universidade do Vale do Sapucai

Investigators

  • Principal Investigator: Joel Veiga-Filho, MD, MSc, Universidade do Vale do Sapucaí and Universidade Federal de São Paulo
  • Study Director: Daniela F Veiga, MD, PhD, Universidade do Vale do Sapucaí and Universidade Federal de São Paulo
  • Study Chair: Lydia M Ferreira, MD, PhD, Universidade do Vale do Sapucaí and Universidade Federal de São Paulo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

February 1, 2009

Primary Completion (Actual)

November 1, 2009

Study Completion (Actual)

September 1, 2010

Study Registration Dates

First Submitted

October 23, 2009

First Submitted That Met QC Criteria

October 26, 2009

First Posted (Estimate)

October 27, 2009

Study Record Updates

Last Update Posted (Actual)

September 4, 2019

Last Update Submitted That Met QC Criteria

September 3, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • dinter01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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