Dressing Wear Time After Breast Augmentation With Prosthesis
Primary Purpose
Surgical Site Infection
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
augmentation mammaplasty
augmentation mammaplasty
Sponsored by
About this trial
This is an interventional supportive care trial for Surgical Site Infection focused on measuring breast prosthesis implantation, bandages, skin colonization, surgical site infection, augmentation mammaplasty, dressing wear time
Eligibility 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
Sites / Locations
- Hospital das Clínicas Samuel Libanio
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Postoperative day 6
Postoperative day 1
Arm Description
Dressing is removed on the sixth postoperative day
Dressing is removed on the first postoperative day
Outcomes
Primary Outcome Measures
skin colonization
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
Surgical site infection will be assessed weekly, for 30 days. CDC´s criteria and definitions will be used.
Full Information
NCT ID
NCT01553604
First Posted
March 12, 2012
Last Updated
September 3, 2019
Sponsor
Daniela Francescato Veiga
1. Study Identification
Unique Protocol Identification Number
NCT01553604
Brief Title
Dressing Wear Time After Breast Augmentation With Prosthesis
Official Title
Influence of Dressing Wear Time on Skin Colonization After Breast Augmentation With Prosthesis: a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
July 2013 (Actual)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
September 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Daniela Francescato Veiga
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgical Site Infection
Keywords
breast prosthesis implantation, bandages, skin colonization, surgical site infection, augmentation mammaplasty, dressing wear time
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Postoperative day 6
Arm Type
Experimental
Arm Description
Dressing is removed on the sixth postoperative day
Arm Title
Postoperative day 1
Arm Type
Experimental
Arm Description
Dressing is removed on the first postoperative day
Intervention Type
Procedure
Intervention Name(s)
augmentation mammaplasty
Intervention Description
Dressing is removed on the first postoperative day
Intervention Type
Procedure
Intervention Name(s)
augmentation mammaplasty
Intervention Description
Dressing is removed on the 6th postoperative day
Primary Outcome Measure Information:
Title
skin colonization
Description
skin colonization will be measured through semi-quantitative cultures of samples collected pre-dressing and on 6th postoperative day.
Time Frame
6 days postoperatively
Secondary Outcome Measure Information:
Title
surgical site infection
Description
Surgical site infection will be assessed weekly, for 30 days. CDC´s criteria and definitions will be used.
Time Frame
30 days postoperatively
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Months
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniela F Veiga, MD, PhD
Organizational Affiliation
Universidade Federal de São Paulo
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Joel Veiga-Filho, MD, PhD
Organizational Affiliation
Universidade do Vale do Sapucaí
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lydia M Ferreira, MD, PhD
Organizational Affiliation
Universidade Federal de São Paulo
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Denise A Mendes, MD, PhD
Organizational Affiliation
Universidade Federal de São Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital das Clínicas Samuel Libanio
City
Pouso Alegre
State/Province
Minas Gerais
ZIP/Postal Code
37550000
Country
Brazil
12. IPD Sharing Statement
Citations:
PubMed Identifier
25623237
Citation
Mendes Dde A, Veiga DF, Veiga-Filho J, Fonseca FE, de Paiva LF, Novo NF, Loyola AB, Ferreira LM. Application time for postoperative wound dressing following breast augmentation with implants: study protocol for a randomized controlled trial. Trials. 2015 Jan 27;16:19. doi: 10.1186/s13063-014-0529-5.
Results Reference
background
PubMed Identifier
29475792
Citation
Mendes DA, Veiga DF, Veiga-Filho J, Loyola ABAT, Paiva LF, Novo NF, Sabino-Neto M, Ferreira LM. Influence of dressing application time after breast augmentation on cutaneous colonization: A randomized clinical trial. J Plast Reconstr Aesthet Surg. 2018 Jun;71(6):906-912. doi: 10.1016/j.bjps.2018.01.021. Epub 2018 Feb 21.
Results Reference
result
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Dressing Wear Time After Breast Augmentation With Prosthesis
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