Dressing Wear Time After Breast Augmentation With Prosthesis

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Federal University of São Paulo
Sponsor:
Information provided by (Responsible Party):
Daniela Francescato Veiga, Federal University of São Paulo
ClinicalTrials.gov Identifier:
NCT01553604
First received: March 12, 2012
Last updated: June 1, 2014
Last verified: June 2014
  Purpose

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 (Caregiver, 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 Federal University of São Paulo:

Primary Outcome Measures:
  • skin colonization [ Time Frame: 6 days postoperatively ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Surgical site infection will be assessed weekly, for 30 days. CDC´s criteria and definitions will be used.


Estimated Enrollment: 80
Study Start Date: July 2013
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: December 2014 (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.

  Eligibility

Ages Eligible for Study:   18 Months to 60 Years
Genders 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01553604

Contacts
Contact: Daniela F Veiga, MD, PhD 55-35-34223298 danielafveiga@gmail.com.br
Contact: Denise A Mendes, MD 55-35-98166802 deniseamendes@uol.com.br

Locations
Brazil
Hospital das Clínicas Samuel Libanio Recruiting
Pouso Alegre, Minas Gerais, Brazil, 37550000
Contact: Denise A Mendes, MD    55-35-98166802    deniseamendes@uol.com.br   
Contact: Daniela F Veiga, MD, PhD    55-35-34223298    danielafveiga@gmail.com   
Sub-Investigator: Joel Veiga-Filho, MD, PhD         
Sub-Investigator: Daniela F Veiga, MD, PhD         
Principal Investigator: Denise A Mendes, MD         
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
  More Information

No publications provided

Responsible Party: Daniela Francescato Veiga, Professor, Federal University of São Paulo
ClinicalTrials.gov Identifier: NCT01553604     History of Changes
Other Study ID Numbers: Micro02
Study First Received: March 12, 2012
Last Updated: June 1, 2014
Health Authority: Brazil: Ethics Committee

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

Additional relevant MeSH terms:
Infection

ClinicalTrials.gov processed this record on October 20, 2014