Single Dose Versus 24 Hours Antibiotic Prophylaxis in Reduction Mammaplasty

Wound Infection Clinical Trial

Official title:

Single Dose Versus 24 Hours Antibiotic Prophylaxis in Reduction Mammaplasty: a Randomized Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04079686
• Other study ID #: PosDoc
• Status: Recruiting
• Phase: N/A
• Start date: August 5, 2019
• Est. completion date: May 2024

Study information

• Verified date: July 2022
• Source: Federal University of São Paulo
• Contact: Daniela F Veiga, MD, PhD
• Phone: 55-11-55764848
• Email: danielafveiga[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Setting: Translacional Surgery Graduation Program - Universidade Federal de São Paulo and Hospital das Clínicas Samuel Libânio - Universidade do Vale do Sapucaí. Background: Breast reduction is one of the most performed plastic surgery procedures. Antibiotics are widely prescribed, on an empirical basis, to prevent surgical site infections. However, there is a lack of evidence to support its use. Objective: To compare the influence of the use of prophylatic antibiotics as a single dose or for 24 hours on surgical site infection rates following reduction mammaplasty. Methods: Randomized trial of non-inferiority, with two parallel groups, double blinded. A total of 146 breast hypertrophy patients, with reduction mammaplasty already scheduled, will be enrolled. Patients will be randomly allocated to group A, that will receive antibiotics only at the anesthesia induction (n=73), or to group B, that will receive antibiotics at the anesthesia induction and for 24 hours (n=73). None of the patients will receive antibiotics after hospital discharge. Patients will be followed-up weekly, for 30 days, regarding surgical site infection. The Centers for Disease Control and Prevention criteria will be applied. A statistical analysis of the data will be performed.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 146
• Est. completion date: May 2024
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• 18 and 60 years of age

• body mass index (BMI) between 19 and 30 kg/m2

• breast hypertrophy according to the criteria of Sacchini et al. and Franco and Rebello

Exclusion Criteria:

• patients who had previously undergone another surgical procedure of the breast

• patients who have been diagnosed with a breast pathology

• smokers

• patients who had a child or breastfed within the last year

• patients with uncontrolled comorbidities, such as arterial hypertension or diabetes

• use of immunosuppressants

• patients who had any infection during the follow-up period, requiring the use of antibiotics

• patients who present any adverse effects due to the antibiotics during the study

• patients who miss follow-up assessments

• patients who withdraw their consent at any time

Related Conditions & MeSH terms

• Anti-bacterial Agents
• Mammaplasty
• Plastic Surgery
• Prophylaxis
• Wound Infection

Intervention

Drug:
• Cephazolin
Patients undergoing reduction mammaplasty will receive 1g of cephazolin intravenously anesthetic induction and postoperatively every 6 hours, for 24 hours.

Other:
• Sterile saline
Patients undergoing reduction mammaplasty will receive 1g of cephazolin intravenously anesthetic induction and intravenous sterile saline postoperatively, every 6 hours, for 24 hours.

Locations

Country	Name	City	State
Brazil	Hospital das Clinicas Samuel Libânio, Universidade do Vale do Sapucaí	Pouso Alegre	MG

Sponsors (1)

Lead Sponsor	Collaborator
Daniela Francescato Veiga

Country where clinical trial is conducted

Brazil, 

References & Publications (1)

Veiga DF, da Silva Garcia E, Moreira-Filho JW, de Mattos Andrade EB, Juliano Y, Veiga-Filho J, Ferreira LM. Single dose versus 24 h antibiotic prophylaxis in reduction mammaplasty: study protocol for a randomized controlled trial. Trials. 2020 Jul 2;21(1):605. doi: 10.1186/s13063-020-04539-0. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with surgical site infection (SSI)	Patients will be monitored for the occurrence of SSI once weekly during the first 30 days following hospital discharge by a single surgeon who is blinded to their treatment group. SSI will be evaluated based on the definition adopted by the Centers for Disease Control and Prevention.	30 days

External Links

•   Study Protocol