Single dose versus 24 h antibiotic prophylaxis in reduction mammaplasty: study protocol for a randomized controlled trial
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 influen...
| Main Authors: | , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
BMC
2020-07-01
|
| Series: | Trials |
| Subjects: | |
| Online Access: | http://link.springer.com/article/10.1186/s13063-020-04539-0 |
| _version_ | 1828410400181321728 |
|---|---|
| author | Daniela Francescato Veiga Edgard da Silva Garcia José Wilson Moreira-Filho Evelyne Borges de Mattos Andrade Yara Juliano Joel Veiga-Filho Lydia Masako Ferreira |
| author_facet | Daniela Francescato Veiga Edgard da Silva Garcia José Wilson Moreira-Filho Evelyne Borges de Mattos Andrade Yara Juliano Joel Veiga-Filho Lydia Masako Ferreira |
| author_sort | Daniela Francescato Veiga |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-12-10T12:10:35Z |
| format | Article |
| id | doaj.art-3cc250e552e2409096d865a3a41552aa |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-12-10T12:10:35Z |
| publishDate | 2020-07-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj.art-3cc250e552e2409096d865a3a41552aa2022-12-22T01:49:22ZengBMCTrials1745-62152020-07-012111910.1186/s13063-020-04539-0Single dose versus 24 h antibiotic prophylaxis in reduction mammaplasty: study protocol for a randomized controlled trialDaniela Francescato Veiga0Edgard da Silva Garcia1José Wilson Moreira-Filho2Evelyne Borges de Mattos Andrade3Yara Juliano4Joel Veiga-Filho5Lydia Masako Ferreira6Translational Surgery Graduate Program, Universidade Federal de São PauloDivision of Plastic Surgery, Department of Surgery, Universidade do Vale do SapucaíDivision of Plastic Surgery, Department of Surgery, Universidade do Vale do SapucaíDivision of Plastic Surgery, Department of Surgery, Universidade do Vale do SapucaíDepartment of Bioestatistics, Universidade Federal de São Paulo, and Universidade de Santo AmaroDivision of Plastic Surgery, Department of Surgery, Universidade do Vale do SapucaíTranslational Surgery Graduate Program, Universidade Federal de São PauloAbstract 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.http://link.springer.com/article/10.1186/s13063-020-04539-0Plastic surgeryMammaplastyAnti-bacterial agentsProphylaxisWound infection |
| spellingShingle | Daniela Francescato Veiga Edgard da Silva Garcia José Wilson Moreira-Filho Evelyne Borges de Mattos Andrade Yara Juliano Joel Veiga-Filho Lydia Masako Ferreira Single dose versus 24 h antibiotic prophylaxis in reduction mammaplasty: study protocol for a randomized controlled trial Trials Plastic surgery Mammaplasty Anti-bacterial agents Prophylaxis Wound infection |
| title | Single dose versus 24 h antibiotic prophylaxis in reduction mammaplasty: study protocol for a randomized controlled trial |
| title_full | Single dose versus 24 h antibiotic prophylaxis in reduction mammaplasty: study protocol for a randomized controlled trial |
| title_fullStr | Single dose versus 24 h antibiotic prophylaxis in reduction mammaplasty: study protocol for a randomized controlled trial |
| title_full_unstemmed | Single dose versus 24 h antibiotic prophylaxis in reduction mammaplasty: study protocol for a randomized controlled trial |
| title_short | Single dose versus 24 h antibiotic prophylaxis in reduction mammaplasty: study protocol for a randomized controlled trial |
| title_sort | single dose versus 24 h antibiotic prophylaxis in reduction mammaplasty study protocol for a randomized controlled trial |
| topic | Plastic surgery Mammaplasty Anti-bacterial agents Prophylaxis Wound infection |
| url | http://link.springer.com/article/10.1186/s13063-020-04539-0 |
| work_keys_str_mv | AT danielafrancescatoveiga singledoseversus24hantibioticprophylaxisinreductionmammaplastystudyprotocolforarandomizedcontrolledtrial AT edgarddasilvagarcia singledoseversus24hantibioticprophylaxisinreductionmammaplastystudyprotocolforarandomizedcontrolledtrial AT josewilsonmoreirafilho singledoseversus24hantibioticprophylaxisinreductionmammaplastystudyprotocolforarandomizedcontrolledtrial AT evelyneborgesdemattosandrade singledoseversus24hantibioticprophylaxisinreductionmammaplastystudyprotocolforarandomizedcontrolledtrial AT yarajuliano singledoseversus24hantibioticprophylaxisinreductionmammaplastystudyprotocolforarandomizedcontrolledtrial AT joelveigafilho singledoseversus24hantibioticprophylaxisinreductionmammaplastystudyprotocolforarandomizedcontrolledtrial AT lydiamasakoferreira singledoseversus24hantibioticprophylaxisinreductionmammaplastystudyprotocolforarandomizedcontrolledtrial |