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Completed

NCT Number: NCT02569866

Antibiotics After Breast Reduction:Clinical Trial With Randomization

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

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Key information

Conditions

Surgical Site Infection Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Surgical Wound Infection Wound Infection

Age range

18 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Hospital das Clínicas Samuel Libanio

Pouso Alegre, Minas Gerais, 37553079, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cephalexin

Drug

Capsules containing cephalexin/500mg

Placebo

Drug

Capsules containing placebo/500mg

Primary outcomes

  1. Surgical site infection in the postoperative of reduction mammaplasty.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Federal University of São Paulo

Other

Collaborators

  • Universidade do Vale do Sapucai

Registry information

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Oct 7, 2015
Registry last updated
Apr 20, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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