Antibiotics After Breast Reduction:Clinical Trial With Randomization

Federal University of São Paulo

Status and phase: Completed; Phase 2

Conditions: Surgical Site Infection

Treatments: Drug: Placebo; Drug: Cephalexin

Study type: Interventional

Funder types: Other

Identifiers

NCT02569866

ESG180402

Details and patient eligibility

About

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

Full 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.

Enrollment: 124 patients

Sex: Female

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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124 participants in 2 patient groups, including a placebo group

Antibiotics Group

Active Comparator group

Description:

Capsules containing cephalexin/500mg will be administrated to the subjects, 4 times daily, for seven days during the postoperative period of reduction mammaplasty.

Treatment:

Drug: Cephalexin

Placebo Group

Placebo Comparator group

Description:

Capsules containing placebo/500mg will be administrated to the subjects, 4 times daily, for seven days during the postoperative period of reduction mammaplasty.

Treatment:

Drug: Placebo