Dressing Wear Time After Reduction Mammaplasty
Twenty-four Hours or 6 Days? A Prospective Randomized Trial Comparing Dressing Wear Time After Reduction Mammaplasty
1 other identifier
interventional
70
1 country
1
Brief Summary
This study was designed to determine whether the duration of dressing wear following reduction mammaplasty influence skin colonization and 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 Feb 2009
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
Study Start
First participant enrolled
February 1, 2009
CompletedFirst Submitted
Initial submission to the registry
October 23, 2009
CompletedFirst Posted
Study publicly available on registry
October 27, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2010
CompletedSeptember 4, 2019
September 1, 2019
9 months
October 23, 2009
September 3, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
surgical site infection
30 days postoperatively
Secondary Outcomes (1)
skin colonization
6 days postoperatively
Study Arms (2)
Postoperative day 1
EXPERIMENTALDressing is removed on the first postoperative day
Postoperative day 6
EXPERIMENTALDressing is removed on the sixth postoperative day
Interventions
Dressing following reduction mammaplasty is removed on the first postoperative day
Eligibility Criteria
You may qualify if:
- breast hypertrophy
- candidate to reduction mammaplasty
- 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
- Daniela Francescato Veigalead
- Universidade do Vale do Sapucaicollaborator
Study Sites (1)
Hospital das Clínicas Samuel Libânio - UNIVÁS
Pouso Alegre, Minas Gerais, 37550000, Brazil
Related Publications (1)
Veiga-Filho J, Veiga DF, Sabino-Neto M, Damasceno CAV, Sales EML, Garcia ES, Oliveira IB, De Simoni LF, Juliano Y, Ferreira LM. Dressing wear time after reduction mammaplasty: a randomized controlled trial. Plast Reconstr Surg. 2012 Jan;129(1):1e-7e. doi: 10.1097/PRS.0b013e3182361ee9.
PMID: 22186564RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Joel Veiga-Filho, MD, MSc
Universidade do Vale do Sapucaí and Universidade Federal de São Paulo
- STUDY DIRECTOR
Daniela F Veiga, MD, PhD
Universidade do Vale do Sapucaí and Universidade Federal de São Paulo
- STUDY CHAIR
Lydia M Ferreira, MD, PhD
Universidade do Vale do Sapucaí and Universidade Federal de São Paulo
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
October 23, 2009
First Posted
October 27, 2009
Study Start
February 1, 2009
Primary Completion
November 1, 2009
Study Completion
September 1, 2010
Last Updated
September 4, 2019
Record last verified: 2019-09