Antibiotics After Breast Reduction:Clinical Trial With Randomization

Surgical Site Infection Clinical Trial

Official title:

Antibiotics After Breast Reduction:Clinical Trial With Randomization

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02569866
• Other study ID #: ESG180402
• Status: Completed
• Phase: Phase 2
• First received: October 4, 2015
• Last updated: April 18, 2018
• Start date: November 2014
• Est. completion date: August 2016

Study information

• Verified date: April 2018
• Source: Federal University of São Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 124
• Est. completion date: August 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Surgical Site Infection
• Surgical Wound Infection

Intervention

Drug:
• Cephalexin
Capsules containing cephalexin/500mg
• Placebo
Capsules containing placebo/500mg

Locations

Country	Name	City	State
Brazil	Hospital das Clínicas Samuel Libanio	Pouso Alegre	Minas Gerais

Sponsors (2)

Lead Sponsor	Collaborator
Federal University of São Paulo	Universidade do Vale do Sapucai

Country where clinical trial is conducted

Brazil, 

References & Publications (1)

Veiga-Filho J, Veiga DF, Sabino-Neto M, Amorim MC, Novo NF, Ferreira LM. The role of antibiotics in reduction mammaplasty. Ann Plast Surg. 2010 Aug;65(2):144-6. doi: 10.1097/SAP.0b013e3181c47d88. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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