Single dose versus 24 h antibiotic prophylaxis in reduction mammaplasty: study protocol for a randomized controlled trial

Trials

卷:21

Yara Juliano¹  Edgard da Silva Garcia²  Joel Veiga-Filho²  Evelyne Borges de Mattos Andrade²  José Wilson Moreira-Filho²  Lydia Masako Ferreira³  Daniela Francescato Veiga³ 

[1] Department of Bioestatistics, Universidade Federal de São Paulo, and Universidade de Santo Amaro;

[2] Division of Plastic Surgery, Department of Surgery, Universidade do Vale do Sapucaí;

[3] Translational Surgery Graduate Program, Universidade Federal de São Paulo;

关键词: Plastic surgery;    Mammaplasty;    Anti-bacterial agents;    Prophylaxis;    Wound infection;   

DOI  :  10.1186/s13063-020-04539-0

来源: DOAJ

【 摘 要 】

Abstract Background Reduction mammaplasty is among the most commonly performed procedures in plastic surgery. Antibiotics are widely prescribed, on an empirical basis, to prevent surgical site infections. However, there is a lack of evidence to support its use. This trial aims to compare the influence of the use of prophylatic antibiotics as a single dose or for 24 h on surgical site infection rates following reduction mammaplasty. Methods Randomized trial of non-inferiority, with two parallel groups. A total of 146 breast hypertrophy patients, with reduction mammaplasty already scheduled, will be enrolled. Patients will be randomly allocated to the placebo group that will receive antibiotics only at the anesthesia induction (n = 73) or to the antibiotics group that will receive antibiotics at the anesthesia induction and for 24 h (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. Discussion Previous studies have demonstrated a decrease in infection rates after reduction mammaplasty when antibiotic prophylaxis was used, compared to the use of no antibiotics. However, the duration of antibiotic prophylaxis remains a point to be clarified. This study will test the hypothesis that maintaining the use of antibiotics for 24 h does not reduce infection rates compared to the use of a single preoperative dose. Trial registration Clinicaltrials.gov NCT04079686 . Registered on September 6, 2019.

【 授权许可】

Unknown