Injury (19%) 22, (2), Ill-113
Printed in Greaf &fain
111
Is antibiotic prophylaxis necessary for internal fixation of low-energy fractures? S. P. F. Hughes’, R. S. Miles*, M. Littlejohn’ and E. Brown2 ‘Departments of Orthopaedic Surgery and Bacteriology, Research Ltd, Greenford, Middlesex, UK
University
A series of 54 pafienfs who had low-energy,closedfiacfures requiting infernal f&ion were entered info a randomized prospective sfudy comparing prophylacticanfibioficswith no freafmenf. In five patients who did not have anfibiofkx a supeqkial wouna’ infection or fever was recorded. In those who received anfibiofics,no infection or fever was detecffd. However,therewasno statistical diffprencebetweenthe fwogroups,and if is concltuledthat there is no netd for prophylactic antibiotics when infernally jixing low-energyfracfures.
Introduction The indications for internal fixation of fractures has increased over recent years. However, it has been shown that postoperative wound infections following orthopaedic surgery can result in increased morbidity (Pulles, 1983). Patzakis et al. (1974), in a prospective randomized trial, investigated the role of prophylactic antibiotics and found a lower infection rate with cephalosporins when compared with antibiotics such as streptomycin and penicillin. However, to date there have been few prospective studies designed to evaluate the role of antibiotic prophylaxis in preventing wound infection and reducing morbidity following internal fixation of fractures. In previous studies we have shown that cefuroxime given intravenously at the time of surgery is present in high concentrations in ail tissues, including bone (Hughes et al., 1982). Further studies using radioactive labelled antibiotics have demonstrated that antibiotic enters bone in high concentrations (Hughes and Anderson, 198.5; Pinto et al., 1986). In this study we set out to assess the efficacy of a single prophylactic dose of cefuroxime, a broad-spectrum cephalosporin which is effective against gram-positive and most gram-negative organisms in the prevention of wound infection following internal fixation of fractures, and to compare this with a control group receiving no treatment.
of Edinburgh,
0
1991 Butterworth-Heinemann
0020-1383/91/020111-03
Ltd
UK and 2Glaxo Group
single dose of 1.5 g cefuroxime intravenously at induction of anaesthesia, and 29 patients (group B) received no antibiotics. The type of fracture, the operation, the status of the surgeon, duration of the operation and the presence of drains were recorded. The wound was inspected at regular intervals postoperatively and infection recorded (Table I). The length of hospital stay and postoperative complications were also noted. There were equal numbers of males and females in each group and age and body weight were similar (Table U). The types of fractures in this study were all low energy, because all high-energy fractures were considered by participating surgeons to be at too great a risk from infection not to receive antibiotics. The results were analysed with two-sided statistical tests using the SAS computer package. The analysis of incidence of postoperative wound infection was performed using Table I. Definition of infection Superficial
Superficial to the deep fascia Discharge Erythema f Bacteriological culture No delay in wound healing
Deep
Extending to the deep fascia Persistent wound discharge f Bacteriological cultures Delay in wound healing
Table II. Sex, age and weight of 2 groups. Group A Cefuroxime (N=25)
Group B No treatment (N=29)
Sex
Male Female
18 7
21 8
Age (years)
Mean S.D. Range
44.1 21.6 18-76
42.8 19.7 18-80
Weight
Mean S.D. Range
70.0 16.6 41.6-l 21 .o
Method This study took the form of an open, randomized, parallel design with the patients in two groups, 54 patients were entered into the study, 25 patients (group A) received a
Edinburgh,
73.0 14.4 48.6109
Hughes et al.: Antibiotic prophylaxis in internal fixation of fractures
112
Fisher’s exact test and the length of stay in hospital using the Wilcoxon matched-pairs test. Estimates of treatment differences and 95 per cent confidence intervals were obtained for this variable, using the method of Hollander and Wolfe (1973).
response. No patient had an established bone infection. As would be expected, given the general low incidence of the presence of postoperative wound infection, the analysis of this variable showed no statistically significant difference between the groups (I’= 0.2). (Table V). Length of hospital
Results The distribution of fractures in the study is shown in Table Ill. The types of fixation used were: plate and screws, screws, pins and intramedullary nails. As these were low-energy fractures, the majority were operated upon by career grade registrars or senior registrars, and not by senior staff. The length of operative procedure for the total population is shown in Table IV and is the same in both groups. All the wounds were closed primarily and all but one patient had their drainage system removed by 48 hours. Postoperative
infections
A total of seven patients, two from group A and five from group B had postoperative complications. There was no wound infection or fever in any patient in group A, whilst there were three superficial wound infections and two patients with fever in group B. One patient in each group had a urinary tract infection and one patient in group A had a respiratory infection. The organisms grown from the infected wounds included Staphylococcus aureus and Profew spp. Cefuroxime and ceftazidime were used to treat the three infections, with an early
Table III. Fracture type - total population Number
Fracture type
of patients
stay
The analysis of length of time spent in hospital by each patient, showed no statistically significant difference between the two groups (P=O.97). The estimated treatment difference was 0 days and the 95 per cent confidence interval shows that the time/treatment difference is unlikely to be greater than I day (Table VI).
Discussion In this small group of patients who had undergone internal fixation of fractures as a result of low-energy injuries such as football, falls, or direct blows, we have been unable to demonstrate the benefit of prophylactic antibiotics. These fractures, treated early, competently and in conventional operating theatres, do not appear to be at an increased risk from normal infections, and even if superficial infection does occur the patient can be treated with appropriate antibiotics. This does not result in any delay in discharging the patient from hospital. If infection in bone does occur following surgery, Simchen et al. (1984) showed that the length of stay of infected patients was, on average, 17.9 days longer than that of individually matched, non-infected controls. It is our conclusion that it is unnecessary to give prophylactic antibiotics to patients undergoing internal fixation for low-energy closed fractures. However, the place of prophylactic antibiotics following high-energy closed fractures has not been addressed in this paper and requires further study.
Group B (N = 29) ____~
Group A (N = 25)
Ankle Elbow Shoulder/humerus Forearm Femur Patella Wrist Tibia
13
0 1 1 1 0 0
12 4 4 3 1 1 2 2
Total fractures Total No. of patients
24 24
29 28”
a
Table V. Incidence of postoperative wound infection Group A (N=25) Present Absent Incomplete
Group B (N=29)
0 24 data
(1) P= 0.24
Group A, cefuroxime Group B, no treatment
Group A, cefuroxime Group B, no treatment ‘One patient in group B had two types of fracture.
Table VI. Length of hospital stay - total population Table IV. Duration of operation - total population Group A (N=25)
No. of patients ----
~.. Group A (N = 25)
Group B (N = 29)
~1 h l-2h >2h
7 16 1
20 0
Total No. of patients
24
28
Duration of operation
Group A, cefuroxime Group B, no treatment
a
Hospital stay (days) Median Range (Missing) Treatment difference 95% Confidence interval P-value Group A, cefuroxime Group B, no treatment
Group B (N=29)
4 2-33
4 2-28
(1)
(1)
I-1:01]
0.97
Injury: the British Journal of Accident Surgery (1991) Vol. 22/No.
References Hollander M. and Wolfe D. A. Nonparamefric Statistical Methods. Wiley, Chichester, UK. 1973. Hughes S. P. F., Want S., Darrell J. H. et al. (1982) Prophylactic cefuroxime in total joint replacement. ht. Orthop.6, 155. Hughes S. P. F. and Anderson F. (1985). Penetration of antibiotics into bone. J. Anfirnicrob. Chemother. 15,517. Patzakis M. J., Harvey J. P. and Ivler D. (1974) The role of antibiotics in the management of open fractures. J. Bone Joint Surg. .56A, 532. Pinto M. R., Fleming R. K., Hughes S. P. F. et al. (1986) The volume of distribution of ceftazidiie and albumin in normal, immature and infected bone. J. Antimicrob. Chemother. 18,381.
2
113
Pulles H. J. W. (1983) Infection prophylaxis in orthopaedic surgery. Res. Clin. Fumrns 5,37. Simchen E., Stein H., Sacks T. G. et al. (1984)Multivariate analysis of determinants of postoperative wound infection in orthopaedie patients. J. Hosp. Infect. 5, 137.
Paper accepted 15 June 1990.
Reqw.& for reprints should be addressed to: Professor S. P. F. Hughes, Department of Orthopaedic Surgery, University of Edinburgh, Teviot Place, Edinburgh EH8 9AG, UK.
Printed in Greaf &fain
111
Is antibiotic prophylaxis necessary for internal fixation of low-energy fractures? S. P. F. Hughes’, R. S. Miles*, M. Littlejohn’ and E. Brown2 ‘Departments of Orthopaedic Surgery and Bacteriology, Research Ltd, Greenford, Middlesex, UK
University
A series of 54 pafienfs who had low-energy,closedfiacfures requiting infernal f&ion were entered info a randomized prospective sfudy comparing prophylacticanfibioficswith no freafmenf. In five patients who did not have anfibiofkx a supeqkial wouna’ infection or fever was recorded. In those who received anfibiofics,no infection or fever was detecffd. However,therewasno statistical diffprencebetweenthe fwogroups,and if is concltuledthat there is no netd for prophylactic antibiotics when infernally jixing low-energyfracfures.
Introduction The indications for internal fixation of fractures has increased over recent years. However, it has been shown that postoperative wound infections following orthopaedic surgery can result in increased morbidity (Pulles, 1983). Patzakis et al. (1974), in a prospective randomized trial, investigated the role of prophylactic antibiotics and found a lower infection rate with cephalosporins when compared with antibiotics such as streptomycin and penicillin. However, to date there have been few prospective studies designed to evaluate the role of antibiotic prophylaxis in preventing wound infection and reducing morbidity following internal fixation of fractures. In previous studies we have shown that cefuroxime given intravenously at the time of surgery is present in high concentrations in ail tissues, including bone (Hughes et al., 1982). Further studies using radioactive labelled antibiotics have demonstrated that antibiotic enters bone in high concentrations (Hughes and Anderson, 198.5; Pinto et al., 1986). In this study we set out to assess the efficacy of a single prophylactic dose of cefuroxime, a broad-spectrum cephalosporin which is effective against gram-positive and most gram-negative organisms in the prevention of wound infection following internal fixation of fractures, and to compare this with a control group receiving no treatment.
of Edinburgh,
0
1991 Butterworth-Heinemann
0020-1383/91/020111-03
Ltd
UK and 2Glaxo Group
single dose of 1.5 g cefuroxime intravenously at induction of anaesthesia, and 29 patients (group B) received no antibiotics. The type of fracture, the operation, the status of the surgeon, duration of the operation and the presence of drains were recorded. The wound was inspected at regular intervals postoperatively and infection recorded (Table I). The length of hospital stay and postoperative complications were also noted. There were equal numbers of males and females in each group and age and body weight were similar (Table U). The types of fractures in this study were all low energy, because all high-energy fractures were considered by participating surgeons to be at too great a risk from infection not to receive antibiotics. The results were analysed with two-sided statistical tests using the SAS computer package. The analysis of incidence of postoperative wound infection was performed using Table I. Definition of infection Superficial
Superficial to the deep fascia Discharge Erythema f Bacteriological culture No delay in wound healing
Deep
Extending to the deep fascia Persistent wound discharge f Bacteriological cultures Delay in wound healing
Table II. Sex, age and weight of 2 groups. Group A Cefuroxime (N=25)
Group B No treatment (N=29)
Sex
Male Female
18 7
21 8
Age (years)
Mean S.D. Range
44.1 21.6 18-76
42.8 19.7 18-80
Weight
Mean S.D. Range
70.0 16.6 41.6-l 21 .o
Method This study took the form of an open, randomized, parallel design with the patients in two groups, 54 patients were entered into the study, 25 patients (group A) received a
Edinburgh,
73.0 14.4 48.6109
Hughes et al.: Antibiotic prophylaxis in internal fixation of fractures
112
Fisher’s exact test and the length of stay in hospital using the Wilcoxon matched-pairs test. Estimates of treatment differences and 95 per cent confidence intervals were obtained for this variable, using the method of Hollander and Wolfe (1973).
response. No patient had an established bone infection. As would be expected, given the general low incidence of the presence of postoperative wound infection, the analysis of this variable showed no statistically significant difference between the groups (I’= 0.2). (Table V). Length of hospital
Results The distribution of fractures in the study is shown in Table Ill. The types of fixation used were: plate and screws, screws, pins and intramedullary nails. As these were low-energy fractures, the majority were operated upon by career grade registrars or senior registrars, and not by senior staff. The length of operative procedure for the total population is shown in Table IV and is the same in both groups. All the wounds were closed primarily and all but one patient had their drainage system removed by 48 hours. Postoperative
infections
A total of seven patients, two from group A and five from group B had postoperative complications. There was no wound infection or fever in any patient in group A, whilst there were three superficial wound infections and two patients with fever in group B. One patient in each group had a urinary tract infection and one patient in group A had a respiratory infection. The organisms grown from the infected wounds included Staphylococcus aureus and Profew spp. Cefuroxime and ceftazidime were used to treat the three infections, with an early
Table III. Fracture type - total population Number
Fracture type
of patients
stay
The analysis of length of time spent in hospital by each patient, showed no statistically significant difference between the two groups (P=O.97). The estimated treatment difference was 0 days and the 95 per cent confidence interval shows that the time/treatment difference is unlikely to be greater than I day (Table VI).
Discussion In this small group of patients who had undergone internal fixation of fractures as a result of low-energy injuries such as football, falls, or direct blows, we have been unable to demonstrate the benefit of prophylactic antibiotics. These fractures, treated early, competently and in conventional operating theatres, do not appear to be at an increased risk from normal infections, and even if superficial infection does occur the patient can be treated with appropriate antibiotics. This does not result in any delay in discharging the patient from hospital. If infection in bone does occur following surgery, Simchen et al. (1984) showed that the length of stay of infected patients was, on average, 17.9 days longer than that of individually matched, non-infected controls. It is our conclusion that it is unnecessary to give prophylactic antibiotics to patients undergoing internal fixation for low-energy closed fractures. However, the place of prophylactic antibiotics following high-energy closed fractures has not been addressed in this paper and requires further study.
Group B (N = 29) ____~
Group A (N = 25)
Ankle Elbow Shoulder/humerus Forearm Femur Patella Wrist Tibia
13
0 1 1 1 0 0
12 4 4 3 1 1 2 2
Total fractures Total No. of patients
24 24
29 28”
a
Table V. Incidence of postoperative wound infection Group A (N=25) Present Absent Incomplete
Group B (N=29)
0 24 data
(1) P= 0.24
Group A, cefuroxime Group B, no treatment
Group A, cefuroxime Group B, no treatment ‘One patient in group B had two types of fracture.
Table VI. Length of hospital stay - total population Table IV. Duration of operation - total population Group A (N=25)
No. of patients ----
~.. Group A (N = 25)
Group B (N = 29)
~1 h l-2h >2h
7 16 1
20 0
Total No. of patients
24
28
Duration of operation
Group A, cefuroxime Group B, no treatment
a
Hospital stay (days) Median Range (Missing) Treatment difference 95% Confidence interval P-value Group A, cefuroxime Group B, no treatment
Group B (N=29)
4 2-33
4 2-28
(1)
(1)
I-1:01]
0.97
Injury: the British Journal of Accident Surgery (1991) Vol. 22/No.
References Hollander M. and Wolfe D. A. Nonparamefric Statistical Methods. Wiley, Chichester, UK. 1973. Hughes S. P. F., Want S., Darrell J. H. et al. (1982) Prophylactic cefuroxime in total joint replacement. ht. Orthop.6, 155. Hughes S. P. F. and Anderson F. (1985). Penetration of antibiotics into bone. J. Anfirnicrob. Chemother. 15,517. Patzakis M. J., Harvey J. P. and Ivler D. (1974) The role of antibiotics in the management of open fractures. J. Bone Joint Surg. .56A, 532. Pinto M. R., Fleming R. K., Hughes S. P. F. et al. (1986) The volume of distribution of ceftazidiie and albumin in normal, immature and infected bone. J. Antimicrob. Chemother. 18,381.
2
113
Pulles H. J. W. (1983) Infection prophylaxis in orthopaedic surgery. Res. Clin. Fumrns 5,37. Simchen E., Stein H., Sacks T. G. et al. (1984)Multivariate analysis of determinants of postoperative wound infection in orthopaedie patients. J. Hosp. Infect. 5, 137.
Paper accepted 15 June 1990.
Reqw.& for reprints should be addressed to: Professor S. P. F. Hughes, Department of Orthopaedic Surgery, University of Edinburgh, Teviot Place, Edinburgh EH8 9AG, UK.
