Prophylaxis of Wound Infections-antibiotics in Renal Donation (POWAR): A UK Multicentre Double Blind Placebo Controlled Randomised Trial.
Adult
Amoxicillin-Potassium Clavulanate Combination
/ administration & dosage
Antibiotic Prophylaxis
Double-Blind Method
Female
Humans
Laparoscopy
Living Donors
Male
Middle Aged
Nephrectomy
Respiratory Tract Infections
/ prevention & control
Surgical Wound Infection
/ prevention & control
United Kingdom
Urinary Tract Infections
/ prevention & control
Journal
Annals of surgery
ISSN: 1528-1140
Titre abrégé: Ann Surg
Pays: United States
ID NLM: 0372354
Informations de publication
Date de publication:
07 2020
07 2020
Historique:
pubmed:
13
11
2019
medline:
18
8
2020
entrez:
13
11
2019
Statut:
ppublish
Résumé
Postoperative infection after hand-assisted laparoscopic donor nephrectomy (HALDN) confers significant morbidity to a healthy patient group. Current UK guidelines cite a lack of evidence for routine antibiotic prophylaxis. This trial assessed if a single preoperative antibiotic dose could reduce post HALDN infections. Eligible donors were randomly and blindly allocated to preoperative single-dose intravenous co-amoxiclav or saline. The primary composite endpoint was clinical evidence of any postoperative infection at 30 days, including surgical site infection (SSI), urinary tract infection (UTI), and lower respiratory tract infection (LRTI). In all, 293 participants underwent HALDN (148 antibiotic arm and 145 placebo arm). Among them, 99% (291/293) completed follow-up. The total infection rate was 40.7% (59/145) in the placebo group and 23% (34 of 148) in the antibiotic group (P = 0.001). Superficial SSIs were 20.7% (30/145 patients) in the placebo group versus 10.1% (15/148 patients) in the antibiotic group (P = 0.012). LRTIs were 9% (13/145) in the placebo group and 3.4% (5/148) in the antibiotic group (P = 0.046). UTIs were 4.1% (6/145) in the placebo group and 3.4% (5/148) in the antibiotic group (P = 0.72).Antibiotic prophylaxis conferred a 17.7% (95% confidence interval 7.2%-28.1%), absolute risk reduction in developing postoperative infection, with 6 donors requiring treatment to prevent 1 infection. Single-dose preoperative antibiotic prophylaxis dramatically reduces post-HALDN infection rates, mainly impacting SSIs and LRTIs.
Sections du résumé
BACKGROUND
Postoperative infection after hand-assisted laparoscopic donor nephrectomy (HALDN) confers significant morbidity to a healthy patient group. Current UK guidelines cite a lack of evidence for routine antibiotic prophylaxis. This trial assessed if a single preoperative antibiotic dose could reduce post HALDN infections.
METHODS
Eligible donors were randomly and blindly allocated to preoperative single-dose intravenous co-amoxiclav or saline. The primary composite endpoint was clinical evidence of any postoperative infection at 30 days, including surgical site infection (SSI), urinary tract infection (UTI), and lower respiratory tract infection (LRTI).
FINDINGS
In all, 293 participants underwent HALDN (148 antibiotic arm and 145 placebo arm). Among them, 99% (291/293) completed follow-up. The total infection rate was 40.7% (59/145) in the placebo group and 23% (34 of 148) in the antibiotic group (P = 0.001). Superficial SSIs were 20.7% (30/145 patients) in the placebo group versus 10.1% (15/148 patients) in the antibiotic group (P = 0.012). LRTIs were 9% (13/145) in the placebo group and 3.4% (5/148) in the antibiotic group (P = 0.046). UTIs were 4.1% (6/145) in the placebo group and 3.4% (5/148) in the antibiotic group (P = 0.72).Antibiotic prophylaxis conferred a 17.7% (95% confidence interval 7.2%-28.1%), absolute risk reduction in developing postoperative infection, with 6 donors requiring treatment to prevent 1 infection.
INTERPRETATION
Single-dose preoperative antibiotic prophylaxis dramatically reduces post-HALDN infection rates, mainly impacting SSIs and LRTIs.
Identifiants
pubmed: 31714309
doi: 10.1097/SLA.0000000000003666
pii: 00000658-202007000-00028
doi:
Substances chimiques
Amoxicillin-Potassium Clavulanate Combination
74469-00-4
Types de publication
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
65-71Subventions
Organisme : Department of Health
ID : PB-PG-1010-23108
Pays : United Kingdom
Références
Klop KW, Hussain F, Karatepe O, et al. Incision-related outcome after live donor nephrectomy: a single-center experience. Surg Endosc 2013; 27:2801–2806.
Association JWPoTBTSaTR. United Kingdom Guidelines for Living Donor Kidney Transplantation; 2011. Available at: https://renal.org/wp-content/uploads/2017/06/living-donor-kidney-transplantation.pdf. Accessed June 29, 2018.
Halgrimson WR, Campsen J, Mandell MS, et al. Donor complications following laparoscopic compared to hand-assisted living donor nephrectomy: an analysis of the literature. J Transplant 2010; 2010:825689.
Hadjianastassiou VG, Johnson RJ, Rudge CJ, et al. 2509 living donor nephrectomies, morbidity and mortality, including the UK introduction of laparoscopic donor surgery. Am J Transplant 2007; 7:2532–2537.
Kokkinos C, Nanidis T, Antcliffe D, et al. Comparison of laparoscopic versus hand-assisted live donor nephrectomy. Transplantation 2007; 83:41–47.
Ahmed ZM. N. Contemporary surgical outcomes from 900 hand-assisted laparoscopic donor nephrectomies. Transplant Int 2015; 28: (Suppl 4): 105.
Excellence NIfHaC. Surgical Site Infections: Prevention and Treatment: Clinical Guideline [CG74]; 2017. Available at: https://www.nice.org.uk/guidance/cg74. Accessed June 29, 2018.
Horan TC, Gaynes RP, Martone WJ, et al. CDC definitions of nosocomial surgical site infections, 1992: a modification of CDC definitions of surgical wound infections. Am J Infect Control 1992; 20:271–274.
Olsen MA, Butler AM, Willers DM, et al. Attributable costs of surgical site infection and endometritis after low transverse cesarean delivery. Infect Control Hosp Epidemiol 2010; 31:276–282.
SIGN. Antibiotic Prophylaxis in Surgery: A National Clinical Guideline; 2014. Available at: http://www.sign.ac.uk/assets/sign104.pdf. Accessed June 29, 2018.
Berrios-Torres SI, Umscheid CA, Bratzler DW, et al. Centers for Disease Control and Prevention guideline for the prevention of surgical site infection, 2017. JAMA Surg 2017; 152:784–791.
Zelhof B, McIntyre IG, Fowler SM, et al. Nephrectomy for benign disease in the UK: results from the British Association of Urological Surgeons nephrectomy database. BJU Int 2016; 117:138–144.
Ozdemir-van Brunschot DM, Koning GG, van Laarhoven KC, et al. A comparison of technique modifications in laparoscopic donor nephrectomy: a systematic review and meta-analysis. PLoS One 2015; 10:e0121131.
Kortram K, Ijzermans JN, Dor FJ. Perioperative events and complications in minimally invasive live donor nephrectomy: a systematic review and meta-analysis. Transplantation 2016; 100:2264–2275.
Steiner T, Traue C, Schubert J. [Perioperative antibiotic prophylaxis in transperitoneal tumor nephrectomy: does it lower the rate of clinically significant postoperative infections?]. Urologe A 2003; 42:34–37.
Jang HS, Choi KH, Yang SC, et al. A prospective study of single-dose antibiotic prophylaxis in live donor nephrectomy. Korean J Urol 2011; 52:115–118.
Zomorrodi A, Buhluli A. Is antibiotic usage necessary after donor nephrectomy? A single center experience. Saudi J Kidney Dis Transpl 2008; 19:200–205.
Alberts VP, Minnee RC, Bemelman FJ, et al. Effect of gentamicin-containing collagen sponges on surgical site infection after hand-assisted laparoscopic donor nephrectomy. Surg Infect (Larchmt) 2013; 14:451–454.
Serrano OK, Kirchner V, Bangdiwala A, et al. Evolution of living donor nephrectomy at a single center: long-term outcomes with 4 different techniques in greater than 4000 donors over 50 years. Transplantation 2016; 100:1299–1305.
Bishawi M, Fakhoury M, Denoya PI, et al. Surgical site infection rates: open versus hand-assisted colorectal resections. Tech Coloproctol 2014; 18:381–386.
Sonoda T, Pandey S, Trencheva K, et al. Longterm complications of hand-assisted versus laparoscopic colectomy. J Am Coll Surg 2009; 208:62–66.
Esposito S, Noviello S, Vanasia A, et al. Ceftriaxone versus other antibiotics for surgical prophylaxis: a meta-analysis. Clin Drug Investig 2004; 24:29–39.
Dietrich ES, Bieser U, Frank U, et al. Ceftriaxone versus other cephalosporins for perioperative antibiotic prophylaxis: a meta-analysis of 43 randomized controlled trials. Chemotherapy 2002; 48:49–56.