Antibiotics After Breast Reduction:Clinical Trial With Randomization

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02569866

Enrollment

124

Registered

2015-10-07

Start date

2014-11-30

Completion date

2016-08-31

Last updated

2018-04-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Surgical Site Infection

Keywords

plastic surgery, mammaplasty, wound infection, prophylaxis

Brief 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.

Interventions

DRUGCephalexin

Capsules containing cephalexin/500mg

DRUGPlacebo

Capsules containing placebo/500mg

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 60 Years

Healthy volunteers

Yes

Inclusion criteria

* Breast hypertrophy * Body mass index between 19 to 30 kg/m2

Exclusion criteria

* 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

Design outcomes

Primary

Measure	Time frame	Description
Surgical site infection in the postoperative of reduction mammaplasty.	30 days postoperatively	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.

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 11, 2026