Antibiotics After Breast Reduction:Clinical Trial With Randomization

Sponsor

Federal University of São Paulo (Other)

Overall Status

Completed

CT.gov ID

NCT02569866

Collaborator

Universidade do Vale do Sapucai (Other)

124

Enrollment

Location

Arms

Duration (Months)

5.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Surgical Site Infection	Drug: Cephalexin Drug: Placebo	Phase 2

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

124 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Antibiotics After Breast Reduction:Clinical Trial With Randomization

Study Start Date :

Nov 1, 2014

Actual Primary Completion Date :

May 1, 2016

Actual Study Completion Date :

Aug 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Antibiotics Group 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 Capsules containing cephalexin/500mg
Placebo Comparator: Placebo Group 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 Capsules containing placebo/500mg

Arm

Intervention/Treatment

Active Comparator: Antibiotics Group

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

Capsules containing cephalexin/500mg

Placebo Comparator: Placebo Group

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

Capsules containing placebo/500mg

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital das Clínicas Samuel Libanio	Pouso Alegre	Minas Gerais	Brazil	37553079

Sponsors and Collaborators

Federal University of São Paulo
Universidade do Vale do Sapucai

Investigators

Study Chair: Lydia M Ferreira, PhD, Federal University of Sao Paulo

Study Documents (Full-Text)

None provided.

More Information

Publications

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.

Responsible Party:

Edgard da Silva Garcia, Edgard da Silva Garcia, Professor, Universidade do Vale do Sapucaí, Federal University of São Paulo

ClinicalTrials.gov Identifier:

NCT02569866

Other Study ID Numbers:

ESG180402

First Posted:

Oct 7, 2015

Last Update Posted:

Apr 20, 2018

Last Verified:

Apr 1, 2018

Keywords provided by Edgard da Silva Garcia, Edgard da Silva Garcia, Professor, Universidade do Vale do Sapucaí, Federal University of São Paulo

Additional relevant MeSH terms:

Surgical Wound Infection

Cephalexin

Study Results

No Results Posted as of Apr 20, 2018