Antibiotics After Breast Reduction:Clinical Trial With Randomization

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

Detailed Description
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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.

Official Title
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Antibiotics After Breast Reduction:Clinical Trial With Randomization

Conditions
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Surgical Site Infection

Intervention / Treatment
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* Drug: Cephalexin
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Antibiotics Group<br>Capsules containing cephalexin/500mg will be administrated to the subjects, 4 times daily, for seven days during the postoperative period of reduction mammaplasty. | Drug: Cephalexin<br>* Capsules containing cephalexin/500mg<br>|
| Placebo Comparator: Placebo Group<br>Capsules containing placebo/500mg will be administrated to the subjects, 4 times daily, for seven days during the postoperative period of reduction mammaplasty. | Drug: Placebo<br>* Capsules containing placebo/500mg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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plastic surgery, mammaplasty, wound infection, prophylaxis