NCT02569866

Antibiotics After Breast Reduction:Clinical Trial With Randomization

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 124 (actual)
• Sponsor: Federal University of São Paulo · Academic / Other
• Sex: Female
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

This study was designed to determine the role of antibiotics reduction mammaplasty influence surgical site infections rates.

Detailed description

Prevention of SSI is important due to its morbidity, longer hospital stays and higher costs. In many surgical procedures where the risk of infection is relatively low and the postoperative infection can be treated properly, the role of antibiotics is not clear. Despite the lack of evidence from prospective randomized controlled trials of evaluation, the use of antibiotics in plastic surgery is widespread in order to offer the highest safety standards patients. The breast reduction is defined as "clean surgery" with a lower infection rate to 3.4%. Thus, the antibiotic is not recommended. However, studies have shown a real rate of infection associated with procedures ranging from 4-36%. Thus, this trial was designed to verify the role of antibiotics in reduction mammaplasty.

Conditions

• Surgical Site Infection

Interventions

Type	Name	Description
DRUG	Cephalexin	Capsules containing cephalexin/500mg
DRUG	Placebo	Capsules containing placebo/500mg

Timeline

• Start date: 2014-11-01
• Primary completion: 2016-05-01
• Completion: 2016-08-01
• First posted: 2015-10-07
• Last updated: 2018-04-20

Locations

1 site across 1 country: Brazil