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Dressing Wear Time After Breast Augmentation With Prosthesis

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ClinicalTrials.gov Identifier: NCT01553604
Recruitment Status : Completed
First Posted : March 14, 2012
Last Update Posted : February 11, 2016
Sponsor:
Information provided by (Responsible Party):
Daniela Francescato Veiga, Federal University of São Paulo

Brief Summary:
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 or disease Intervention/treatment Phase
Surgical Site Infection Procedure: augmentation mammaplasty Not Applicable

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  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (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
Study Start Date : July 2013
Actual Primary Completion Date : January 2015
Actual Study Completion Date : September 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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 :
  1. 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.



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

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

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): NCT01553604


Locations
Brazil
Hospital das Clínicas Samuel Libanio
Pouso Alegre, Minas Gerais, Brazil, 37550000
Sponsors and Collaborators
Daniela Francescato Veiga
Investigators
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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Daniela Francescato Veiga, Professor, Federal University of São Paulo
ClinicalTrials.gov Identifier: NCT01553604     History of Changes
Other Study ID Numbers: Micro02
First Posted: March 14, 2012    Key Record Dates
Last Update Posted: February 11, 2016
Last Verified: February 2016

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

Additional relevant MeSH terms:
Surgical Wound Infection
Wound Infection
Infection
Postoperative Complications
Pathologic Processes