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Antibiotics After Breast Reduction:Clinical Trial With Randomization

Primary Purpose

Surgical Site Infection

Status
Completed
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
Cephalexin
Placebo
Sponsored by
Federal University of São Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Surgical Site Infection focused on measuring plastic surgery, mammaplasty, wound infection, prophylaxis

Eligibility Criteria

18 Years - 60 Years (Adult)FemaleAccepts 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

Sites / Locations

  • Hospital das Clínicas Samuel Libanio

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Antibiotics Group

Placebo Group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
October 4, 2015
Last Updated
April 18, 2018
Sponsor
Federal University of São Paulo
Collaborators
Universidade do Vale do Sapucai
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1. Study Identification

Unique Protocol Identification Number
NCT02569866
Brief Title
Antibiotics After Breast Reduction:Clinical Trial With Randomization
Official Title
Antibiotics After Breast Reduction:Clinical Trial With Randomization
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
November 2014 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
August 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of São Paulo
Collaborators
Universidade do Vale do Sapucai

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgical Site Infection
Keywords
plastic surgery, mammaplasty, wound infection, prophylaxis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
124 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Antibiotics Group
Arm Type
Active Comparator
Arm Description
Capsules containing cephalexin/500mg will be administrated to the subjects, 4 times daily, for seven days during the postoperative period of reduction mammaplasty.
Arm Title
Placebo Group
Arm Type
Placebo Comparator
Arm Description
Capsules containing placebo/500mg will be administrated to the subjects, 4 times daily, for seven days during the postoperative period of reduction mammaplasty.
Intervention Type
Drug
Intervention Name(s)
Cephalexin
Intervention Description
Capsules containing cephalexin/500mg
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Capsules containing placebo/500mg
Primary Outcome Measure Information:
Title
Surgical site infection in the postoperative of reduction mammaplasty.
Description
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.
Time Frame
30 days postoperatively

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lydia M Ferreira, PhD
Organizational Affiliation
Federal University of Sao Paulo
Official's Role
Study Chair
Facility Information:
Facility Name
Hospital das Clínicas Samuel Libanio
City
Pouso Alegre
State/Province
Minas Gerais
ZIP/Postal Code
37553079
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
20585232
Citation
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.
Results Reference
background
PubMed Identifier
27899130
Citation
Garcia ES, Veiga DF, Veiga-Filho J, Cabral IV, Pinto NL, Novo NF, Sabino Neto M, Ferreira LM. Antibiotic prophylaxis in reduction mammaplasty: study protocol for a randomized controlled trial. Trials. 2016 Nov 30;17(1):567. doi: 10.1186/s13063-016-1700-y.
Results Reference
derived

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Antibiotics After Breast Reduction:Clinical Trial With Randomization

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