Dressing Wear Time After Breast Augmentation With Prosthesis

September 3, 2019 updated by: Daniela Francescato Veiga

Influence of Dressing Wear Time on Skin Colonization After Breast Augmentation With Prosthesis: a Randomized Controlled Trial

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Augmentation mammaplasty is currently one of the most performed plastic surgery procedures. It is a clean operation, and surgical site infection (SSI) rates are low. However, a SSI, since a minor one, leads to the failure of the procedure. Thus, minimizing SSI risks is imperative.

The Centers for Disease Control and Prevention (CDC) provides recommendations concerning prevention of SSI.No recommendation is offered for some practices, either because there is a lack of consensus regarding their efficacy or because of the available scientific evidence is insufficient to support their adoption.

CDC´s "Guideline for Prevention of Surgical Site Infection" recommends protecting with a sterile dressing for 24 to 48 hours an incision that has been closed primarily. There is no recommendation to cover the incision beyond 48 hours. One major risk factor for SSI is the presence of bacteria at surgical site.Thus, this trial was designed to verify the influence of dressing wear time on skin colonization.

Study Type

Interventional

Enrollment (Actual)

80

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

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

1 year to 60 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • candidate to breast prosthesis implantation
  • 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: augmentation mammaplasty
Dressing is removed on the first postoperative day
Procedure: augmentation mammaplasty
Dressing is removed on the 6th postoperative day
Experimental: Postoperative day 6
Dressing is removed on the sixth postoperative day
Procedure: augmentation mammaplasty
Dressing is removed on the first postoperative day
Procedure: augmentation mammaplasty
Dressing is removed on the 6th postoperative day

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
skin colonization
Time Frame: 6 days postoperatively
skin colonization will be measured through semi-quantitative cultures of samples collected pre-dressing and on 6th postoperative day.
6 days postoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
surgical site infection
Time Frame: 30 days postoperatively
Surgical site infection will be assessed weekly, for 30 days. CDC´s criteria and definitions will be used.
30 days postoperatively

Collaborators and Investigators

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

Sponsor

Daniela Francescato Veiga

Investigators

  • Study Director: Daniela F Veiga, MD, PhD, Universidade Federal de Sao Paulo
  • Principal Investigator: Joel Veiga-Filho, MD, PhD, Universidade do Vale do Sapucai
  • Study Chair: Lydia M Ferreira, MD, PhD, Universidade Federal de Sao Paulo
  • Principal Investigator: Denise A Mendes, MD, PhD, Universidade Federal de Sao 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 (Actual)

July 1, 2013

Primary Completion (Actual)

January 1, 2015

Study Completion (Actual)

September 1, 2015

Study Registration Dates

First Submitted

March 12, 2012

First Submitted That Met QC Criteria

March 13, 2012

First Posted (Estimate)

March 14, 2012

Study Record Updates

Last Update Posted (Actual)

September 6, 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

  • Micro02

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.

Clinical Trials on Surgical Site Infection

Clinical Trials on augmentation mammaplasty

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Denmark

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe