Oral neomycin and bacitracin are effective in preventing surgical site infections in elective colorectal surgery: a multicentre, randomized, parallel, single-blinded trial (COLORAL-1).
Administration, Oral
Anti-Bacterial Agents
/ therapeutic use
Antibiotic Prophylaxis
Bacitracin
COVID-19
Cathartics
/ therapeutic use
Colectomy
Colorectal Surgery
/ adverse effects
Elective Surgical Procedures
Humans
Neomycin
Pandemics
Preoperative Care
SARS-CoV-2
Surgical Wound Infection
/ epidemiology
Colorectal surgery
Oral antibiotics
Surgical site infection
Journal
Updates in surgery
ISSN: 2038-3312
Titre abrégé: Updates Surg
Pays: Italy
ID NLM: 101539818
Informations de publication
Date de publication:
Oct 2021
Oct 2021
Historique:
received:
03
05
2021
accepted:
08
06
2021
pubmed:
21
6
2021
medline:
16
10
2021
entrez:
20
6
2021
Statut:
ppublish
Résumé
Several regimens of oral and intravenous antibiotics (OIVA) have been proposed with contradicting results, and the role of mechanical bowel preparation (MBP) is still controversial. This study aims to assess the effectiveness of oral antibiotic prophylaxis in preventing Surgical Site Infections (SSI) in elective colorectal surgery. In a multicentre trial, we randomized patients undergoing elective colorectal resection surgery, comparing the effectiveness of OIVA versus intravenous antibiotics (IVA) regimens to prevent SSI as the primary outcome (NCT04438655). In addition to intravenous Amoxicillin/Clavulanic, patients in the OIVA group received Oral Neomycin and Bacitracin 24 h before surgery. MBP was administered according to local habits which were not changed for the study. The trial was terminated during the COVID-19 pandemic, as many centers failed to participate as well as the pandemic changed the rules for engaging patients. Two-hundred and four patients were enrolled (100 in the OIVA and 104 in the IVA group); 3 SSIs (3.4%) were registered in the OIVA and 14 (14.4%) in the IVA group (p = 0.010). No difference was observed in terms of anastomotic leak. Multivariable analysis indicated that OIVA reduced the rate of SSI (OR 0.21 / 95% CI 0.06-0.78 / p = 0.019), while BMI is a risk factor of SSI (OR 1.15 / 95% CI 1.01-1.30 p = 0.039). Subgroup analysis indicated that 0/22 patients who underwent OIVA/MBP + vs 13/77 IVA/MBP- experienced an SSI (p = 0.037). The early termination of the study prevents any conclusion regarding the interpretation of the data. Nonetheless, Oral Neomycin/Bacitracin and intravenous beta-lactam/beta-lactamases inhibitors seem to reduce SSI after colorectal resections, although not affecting the anastomotic leak in this trial. The role of MBP requires more investigation.
Identifiants
pubmed: 34148172
doi: 10.1007/s13304-021-01112-5
pii: 10.1007/s13304-021-01112-5
pmc: PMC8214720
doi:
Substances chimiques
Anti-Bacterial Agents
0
Cathartics
0
Bacitracin
1405-87-4
Neomycin
I16QD7X297
Types de publication
Journal Article
Multicenter Study
Randomized Controlled Trial
Langues
eng
Sous-ensembles de citation
IM
Pagination
1775-1786Informations de copyright
© 2021. The Author(s).
Références
Lancet Gastroenterol Hepatol. 2020 Aug;5(8):729-738
pubmed: 32325012
Dis Colon Rectum. 2019 Jan;62(1):3-8
pubmed: 30531263
Nat Rev Microbiol. 2016 Jan;14(1):20-32
pubmed: 26499895
Surg Infect (Larchmt). 2015 Dec;16(6):728-32
pubmed: 26230616
Ann Surg. 2009 Feb;249(2):203-9
pubmed: 19212171
Ann Surg. 2015 Sep;262(3):416-25; discussion 423-5
pubmed: 26258310
Ann Surg. 2009 Oct;250(4):507-13
pubmed: 19734778
Cochrane Database Syst Rev. 2011 Sep 07;(9):CD001544
pubmed: 21901677
Surg Infect (Larchmt). 2010 Aug;11(4):343-8
pubmed: 20695826
Ann Surg. 2004 Aug;240(2):205-13
pubmed: 15273542
Ann Surg. 1973 Oct;178(4):453-62
pubmed: 4743867
Infect Control Hosp Epidemiol. 2007 Sep;28(9):1047-53
pubmed: 17932825
Gastroenterology. 2020 Mar;158(4):958-970.e2
pubmed: 31655031
Am J Infect Control. 1999 Apr;27(2):97-132; quiz 133-4; discussion 96
pubmed: 10196487
Arch Surg. 2003 Jul;138(7):721-5; discussion 726
pubmed: 12860752
Br J Surg. 2018 Jan;105(2):e131-e141
pubmed: 29341151
J Am Coll Surg. 2012 May;214(5):852-9
pubmed: 22440056
Cochrane Database Syst Rev. 2014 May 09;(5):CD001181
pubmed: 24817514
World J Surg. 2019 Mar;43(3):659-695
pubmed: 30426190
Dis Colon Rectum. 2017 Aug;60(8):761-784
pubmed: 28682962
Infect Control Hosp Epidemiol. 2019 Aug;40(8):922-927
pubmed: 31196253
J Hosp Infect. 2017 Feb;95(2):135-136
pubmed: 28139389
Surg Clin North Am. 1997 Jun;77(3):549-73
pubmed: 9194880
Dig Surg. 2020;37(3):192-198
pubmed: 31055568
Br J Surg. 2017 Jan;104(2):e14-e23
pubmed: 28121030
Dis Colon Rectum. 2011 Jul;54(7):810-7
pubmed: 21654247
Ann Surg. 2010 Nov;252(5):863-8
pubmed: 21037443