Antibiotics After Breast Reduction:Clinical Trial With Randomization
1 other identifier
interventional
124
1 country
1
Brief Summary
This study was designed to determine the role of antibiotics reduction mammaplasty influence surgical site infections rates.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Nov 2014
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
November 1, 2014
CompletedFirst Submitted
Initial submission to the registry
October 4, 2015
CompletedFirst Posted
Study publicly available on registry
October 7, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2016
CompletedApril 20, 2018
April 1, 2018
1.5 years
October 4, 2015
April 18, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Surgical site infection in the postoperative of reduction mammaplasty.
After surgery, the patients will be followed for 30 days and surgical site infection rates will be observed in both groups, according to the CDC criteria.
30 days postoperatively
Study Arms (2)
Antibiotics Group
ACTIVE COMPARATORCapsules containing cephalexin/500mg will be administrated to the subjects, 4 times daily, for seven days during the postoperative period of reduction mammaplasty.
Placebo Group
PLACEBO COMPARATORCapsules containing placebo/500mg will be administrated to the subjects, 4 times daily, for seven days during the postoperative period of reduction mammaplasty.
Interventions
Eligibility Criteria
You may qualify if:
- Breast hypertrophy
- Body mass index between 19 to 30 kg/m2
You may not qualify if:
- Patients undergoing a surgical procedure in the breast
- Diagnosis of breast pathology
- Smoking
- Childbirth or lactation less than a year
- Uncontrolled comorbidities
- Use of immunosuppressive drugs
- Misuse of capsules supplied
- Absence during the weekly follow-up
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Federal University of São Paulolead
- Universidade do Vale do Sapucaicollaborator
Study Sites (1)
Hospital das Clínicas Samuel Libanio
Pouso Alegre, Minas Gerais, 37553079, Brazil
Related Publications (2)
Veiga-Filho J, Veiga DF, Sabino-Neto M, Amorim MC, Novo NF, Ferreira LM. The role of antibiotics in reduction mammaplasty. Ann Plast Surg. 2010 Aug;65(2):144-6. doi: 10.1097/SAP.0b013e3181c47d88.
PMID: 20585232BACKGROUNDGarcia ES, Veiga DF, Veiga-Filho J, Cabral IV, Pinto NL, Novo NF, Sabino Neto M, Ferreira LM. Antibiotic prophylaxis in reduction mammaplasty: study protocol for a randomized controlled trial. Trials. 2016 Nov 30;17(1):567. doi: 10.1186/s13063-016-1700-y.
PMID: 27899130DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Lydia M Ferreira, PhD
Federal University of São Paulo
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Edgard da Silva Garcia, Professor, Universidade do Vale do Sapucaí
Study Record Dates
First Submitted
October 4, 2015
First Posted
October 7, 2015
Study Start
November 1, 2014
Primary Completion
May 1, 2016
Study Completion
August 1, 2016
Last Updated
April 20, 2018
Record last verified: 2018-04