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Dressing Wear Time After Breast Augmentation With Prosthesis

This study has been completed.
Information provided by (Responsible Party):
Daniela Francescato Veiga, Federal University of São Paulo Identifier:
First received: March 12, 2012
Last updated: February 10, 2016
Last verified: February 2016
This study was designed to determine whether the duration of dressing wear following augmentation mammaplasty influence skin colonization and eventually surgical site infections rates.

Condition Intervention
Surgical Site Infection
Procedure: augmentation mammaplasty

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Care Provider, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Influence of Dressing Wear Time on Skin Colonization After Breast Augmentation With Prosthesis: a Randomized Controlled Trial

Resource links provided by NLM:

Further study details as provided by Daniela Francescato Veiga, Federal University of São Paulo:

Primary Outcome Measures:
  • 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.

Secondary Outcome Measures:
  • 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.

Enrollment: 80
Study Start Date: July 2013
Study Completion Date: September 2015
Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Postoperative day 6
Dressing is removed on the sixth postoperative day
Procedure: augmentation mammaplasty
Dressing is removed on the 6th postoperative day
Experimental: Postoperative day 1
Dressing is removed on the first postoperative day
Procedure: augmentation mammaplasty
Dressing is removed on the first postoperative day

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.


Ages Eligible for Study:   18 Months to 60 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01553604

Hospital das Clínicas Samuel Libanio
Pouso Alegre, Minas Gerais, Brazil, 37550000
Sponsors and Collaborators
Daniela Francescato Veiga
Study Director: Daniela F Veiga, MD, PhD Universidade Federal de São Paulo
Principal Investigator: Joel Veiga-Filho, MD, PhD Universidade do Vale do Sapucaí
Study Chair: Lydia M Ferreira, MD, PhD Universidade Federal de São Paulo
Principal Investigator: Denise A Mendes, MD Universidade Federal de São Paulo
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Daniela Francescato Veiga, Professor, Federal University of São Paulo Identifier: NCT01553604     History of Changes
Other Study ID Numbers: Micro02
Study First Received: March 12, 2012
Last Updated: February 10, 2016

Keywords provided by Daniela Francescato Veiga, Federal University of São Paulo:
breast prosthesis implantation
skin colonization
surgical site infection
augmentation mammaplasty
dressing wear time

Additional relevant MeSH terms:
Surgical Wound Infection
Wound Infection
Postoperative Complications
Pathologic Processes processed this record on May 25, 2017