Randomized clinical trial of single skin sterilization with a povidone-iodine applicator
Abdomen
/ surgery
Adult
Aged
Aged, 80 and over
Anti-Infective Agents, Local
/ adverse effects
Elective Surgical Procedures
/ trends
Female
Humans
Japan
/ epidemiology
Male
Middle Aged
Povidone-Iodine
/ adverse effects
Prospective Studies
Skin
/ drug effects
Sterilization
/ economics
Surgical Wound Infection
/ epidemiology
Journal
BJS open
ISSN: 2474-9842
Titre abrégé: BJS Open
Pays: England
ID NLM: 101722685
Informations de publication
Date de publication:
06 2019
06 2019
Historique:
received:
06
10
2018
accepted:
17
01
2019
entrez:
12
6
2019
pubmed:
12
6
2019
medline:
12
6
2019
Statut:
epublish
Résumé
The efficacy of widely used povidone-iodine applicators for skin sterilization in abdominal surgery is unclear. The aim of this trial was to evaluate whether sterilization with a povidone-iodine applicator was not inferior to a conventional sterilization method. Patients undergoing elective abdominal surgery were assigned randomly to receive single sterilization with the applicator or conventional sterilization. The primary endpoint was wound infection rate. Secondary endpoints were rate of organ/space surgical-site infection (SSI), adverse effects of povidone-iodine, amount of povidone-iodine used and total cost of sterilization. Of 498 patients eligible for the study between April 2015 and September 2017, 240 were assigned and analysed in the applicator group and 246 in the conventional group. Wound infection was detected in 16 patients (6·7 per cent) in the applicator group and 16 (6·5 per cent) in the conventional group (absolute difference 0·0016 (90 per cent c.i. -0·037 to 0·040) per cent; In abdominal surgery, this povidone-iodine applicator was not inferior to conventional sterilization in terms of the wound infection rate, and it is cheaper. Registration number: UMIN000018231 (http://www.umin.ac.jp/ctr/).
Sections du résumé
Background
The efficacy of widely used povidone-iodine applicators for skin sterilization in abdominal surgery is unclear. The aim of this trial was to evaluate whether sterilization with a povidone-iodine applicator was not inferior to a conventional sterilization method.
Methods
Patients undergoing elective abdominal surgery were assigned randomly to receive single sterilization with the applicator or conventional sterilization. The primary endpoint was wound infection rate. Secondary endpoints were rate of organ/space surgical-site infection (SSI), adverse effects of povidone-iodine, amount of povidone-iodine used and total cost of sterilization.
Results
Of 498 patients eligible for the study between April 2015 and September 2017, 240 were assigned and analysed in the applicator group and 246 in the conventional group. Wound infection was detected in 16 patients (6·7 per cent) in the applicator group and 16 (6·5 per cent) in the conventional group (absolute difference 0·0016 (90 per cent c.i. -0·037 to 0·040) per cent;
Conclusion
In abdominal surgery, this povidone-iodine applicator was not inferior to conventional sterilization in terms of the wound infection rate, and it is cheaper. Registration number: UMIN000018231 (http://www.umin.ac.jp/ctr/).
Identifiants
pubmed: 31183443
doi: 10.1002/bjs5.50144
pii: BJS550144
pmc: PMC6551405
doi:
Substances chimiques
Anti-Infective Agents, Local
0
Povidone-Iodine
85H0HZU99M
Banques de données
UMIN-CTR
['UMIN000018231']
Types de publication
Comparative Study
Journal Article
Randomized Controlled Trial
Langues
eng
Pagination
282-287Références
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