Randomized clinical trial to compare a single dose with 3 doses of prophylactic antibiotic in open reduction and internal fixation of the fractures of long bones
- Author:
Ikau Kevau
1
;
Jerry Kurma
2
Author Information
1. School of Medicine and Health Sciences, University of Papua New Guinea
2. Divine Word University and Modilon General Hospital
- Publication Type:Journal Article
- MeSH:
Clinical Trials as Topic- statistics & numerical data,
- From:
Papua New Guinea medical journal
2015;58(1-4):28-35
- CountryPapua New Guinea
- Language:English
-
Abstract:
To reduce the incidence of surgical site infection (SSI), perioperative antimicrobial
prophylaxis has long been advocated for joint replacement and open reduction with
internal fixation of long bones. Increasing health care costs have focused hospital interest
on more cost-effective procedures. Although current literature indicates that single-dose
antibiotic prophylaxis is comparable to a 3-dose regimen, there are no reports from lowincome
countries. The primary aim of this study was to compare the infection rate following
open reduction and internal fixation of long-bone fractures in groups with a single dose
and 3 doses of prophylactic antibiotic. The secondary aim was to compare the costeffectiveness
of both antibiotic regimens. This is a prospective randomized clinical trial
(RCT) to compare the incidence of surgical site infection between the patients allocated
randomly into two groups with different antibiotic prophylactic regimens: single dose or
3 doses 8 hourly of 1g ceftriaxone administered intravenously. 200 consecutive patients
who underwent open reduction and internal fixation (ORIF) for closed long-bone fractures
were enrolled in this study. The rate of postoperative SSI was 4.1% in the single-dose
group and 2.2% in the 3-dose group; the overall SSI rate was 3.2%. The primary endpoint
of this study, which is the incidence of SSI, showed no significant difference between
the single-dose and 3-dose prophylactic antibiotic groups. Furthermore, there was no
difference between groups regarding the length of hospital stay. Our randomized clinical
trial affirmed that single-dose antibiotic prophylaxis in orthopaedic clean operations is
not only a cost-saving practice but also is effective for SSI prevention, and should be
incorporated in the development of clinical practice guidelines in tropical hospitals.
