Dressing Wear Time After Breast Augmentation With Prosthesis
Influence of Dressing Wear Time on Skin Colonization After Breast Augmentation With Prosthesis: a Randomized Controlled Trial
1 other identifier
interventional
80
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2013
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 12, 2012
CompletedFirst Posted
Study publicly available on registry
March 14, 2012
CompletedStudy Start
First participant enrolled
July 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2015
CompletedSeptember 6, 2019
September 1, 2019
1.5 years
March 12, 2012
September 3, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
skin colonization
skin colonization will be measured through semi-quantitative cultures of samples collected pre-dressing and on 6th postoperative day.
6 days postoperatively
Secondary Outcomes (1)
surgical site infection
30 days postoperatively
Study Arms (2)
Postoperative day 6
EXPERIMENTALDressing is removed on the sixth postoperative day
Postoperative day 1
EXPERIMENTALDressing is removed on the first postoperative day
Interventions
Dressing is removed on the first postoperative day
Eligibility Criteria
You may qualify if:
- candidate to breast prosthesis implantation
- body mass index under 30Kg/m2
You may not qualify if:
- pregnancy, delivery or breast feeding during the last 12 months
- body mass index over 30Kg/m2
- breast cancer history
- previous breast surgery
- hard smoking
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital das Clínicas Samuel Libanio
Pouso Alegre, Minas Gerais, 37550000, Brazil
Related Publications (2)
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.
PMID: 25623237BACKGROUNDMendes 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.
PMID: 29475792RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- 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, PhD
Universidade Federal de São Paulo
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
March 12, 2012
First Posted
March 14, 2012
Study Start
July 1, 2013
Primary Completion
January 1, 2015
Study Completion
September 1, 2015
Last Updated
September 6, 2019
Record last verified: 2019-09