Double-blind randomized prospective study of the efficacy of antibiotic prophylaxis for open reduction and internal fixation of closed ankle fractures. Is antibiotic prophylaxis necessary for internal fixation of low-energy fractures? Antibiotic prophylaxis in open and closed fractures: a controlled clinical trial. Randomised controlled trial of single-dose antibiotic prophylaxis in surgical treatment of closed fractures: the Dutch Trauma Trial. Single-dose antibiotic prophylaxis in osteosynthesis for hip fractures. A clinical multicentre study in Finland. Antibiotic prophylaxis in surgery for hip fractures. Antibiotic prophylaxis in operations on trochanteric femoral fractures. Role of prophylactic antibiotics in open and basilar fractures of the skull: a randomized study. Prophylactic antibiotics in hip fractures. A double-blind, prospective study. A double-blind clinical trial of prophylactic cloxacillin in open fractures. Role of antibiotics in open fractures of the finger. Antibiotic prophylaxis with two doses of cephalosporin in patients managed with internal fixation for a fracture of the hip. Use of antibiotic prophylaxis in ear surgery. Antibiotics in open fractures of the distal phalanx? Antibiotic prophylaxis in proximal femoral fracture. Efficacy of antibiotics in low-velocity gunshot fractures. Antibiotic prophylaxis and open groin hernia repair. [Treatment results in open fractures, aspects of antibiotic therapy]. Antibiotic prophylaxis in vascular reconstructive surgery: a double-blind placebo-controlled study.
Antibioprophylaxis has been proven to be efficient for some orthopaedic procedures. However, its efficacy for clean limited procedures with metallic implants is not clear. One hundred twenty-two closed ankle fracture patients undergoing open reduction and internal fixation were randomized, double-blindly, to receive either cephalothin (1 g i.v. every 6 h x four doses) or a placebo starting before tourniquet application. Mean trauma-surgery delay was 30.2 h, and average tourniquet duration was 65.4 min. Four patients (three of 62 on placebo and one of 60 on cephalothin) developed a superficial wound infection. One of the patients in the placebo group was hospitalized and treated with i.v. antibiotics. However, there was no osteomyelitis or premature hardware removal. The difference between the two groups was not statistically significant (chi 2 test of appreciation p = 0.33, two-tailed probabilities). Therefore, cephalothin prophylaxis does not seem justified in this patient population. A larger series is needed to avoid a type II error. A series of 54 patients who had low-energy, closed fractures requiring internal fixation were entered into a randomized prospective study comparing prophylactic antibiotics with no treatment. In five patients who did not have antibiotics a superficial wound infection or fever was recorded. In those who received antibiotics, no infection or fever was detected. However, there was no statistical difference between the two groups, and it is concluded that there is no need for prophylactic antibiotics when internally fixing low-energy fractures. The value of prophylactic antibiotics in fracture surgery was studied in a series of 90 patients with open fractures of various bones and 180 patients with closed malleolar fractures treated by open surgery. Dicloxacillin and benzyl penicillin were compared to saline (placebo). The soft tissue lesions of the open fractures were divided into Grade I wounds and Grade II & III wounds. Of the patients with Grade I wounds, 17 received dicloxacillin, 21 benzyl penicillin and 17 saline. No major infections occurred. Twelve patients with Grade II & III wounds were treated with dicloxacillin, 10 with benzyl penicillin and 13 with saline. In the saline group, 2 patients developed a deep infection. Fifty-eight patients with closed malleolar fractures received dicloxacillin, 59 benzyl penicillin and 63 saline. Two infections developed in the placebo group. A statistically significant difference was found between the number of infections in the antibiotic groups and the number in the placebo group. Superficial thromboplebitis following the antibiotic infusion occurred in 16 per cent of the dicloxacillin treated patients and in 1 per cent of those treated with benzyl penicillin or placebo. The efficacy of prophylactic antibiotics in fracture surgery remains controversial for lack of well-documented prospective studies. We report here the findings of the Dutch Trauma Trial, a prospective, randomised, double-blind, placebo-controlled study of antibiotic prophylaxis in the primary operative treatment of limb fractures. Ceftriaxone was chosen because of its pharmacokinetic profile, including high serum levels, high tissue penetration, and long elimination half-life, makes it suitable for single-dose prophylaxis.
                Patients aged 18 years or more, attending one of fourteen Dutch centres for acute treatment of closed fractures, were randomly allocated to a single preoperative dose of ceftriaxone 2 g or placebo, and evaluated for development of wound infection and nosocomial infection at 10 days, 30 days, and 120 days. To assess the effects of drop-outs and withdrawals, best-case and worst-case analyses were performed.
                A total of 2195 patients were included. The incidence of superficial and deep wound infections after placebo was 8.3%, compared with 3.6% in the ceftriaxone group (p < 0.001, Pearson chi 2-test). The rate of nosocomial infection in the first month was 10.2% with placebo and 2.3% with ceftriaxone (p < 0.001, Pearson chi 2-test). Gram-positive bacteria were found in 74.5% of wound infections and 13.4% of nosocomial infections.
                Adequate single-dose prophylaxis with a long-acting broad-spectrum antibiotic substantially reduces the incidence of wound infection and early nosocomial infection after surgery for closed fractures. The use of antibiotic prophylaxis in open reduction and osteosynthesis of closed hip fractures is still controversial. The aim of this study was to demonstrate the effect of antibiotic prophylaxis in osteosynthesis of these fractures.
                A total of 224 patients operated on between November 1994 and February 1998 in six hospitals by internal fixation for a fresh hip fracture were prospectively and randomly allocated to either a ceftriaxone antibiotic prophylaxis or no prophylaxis group and followed for one year.
                Within 6 weeks after the operation, 2.6% wound infections were recorded in the antibiotic group and 4.7% in the control group. Two (1.9%) of the five infections in the control group were deep infections (both sensitive to ceftriaxone). There were no statistically significant differences between the infection rates in both groups. However, when analyzing all complications recorded within 6 weeks, significantly more complications were found in the control group (p < 0.01). In the multivariate analysis the most important factor predicting postoperative complications was the lack of antibiotic prophylaxis.
                In this study the antibiotic prophylaxis group had significantly less postoperative complications than the control group within 6 weeks after the operation. Totally, 185 patients, operated on for a fresh hip fracture, were randomly allocated to either methicillin antibiotic prophylaxis or no prophylaxis and followed for 1 month. Two superficial wound infections were recorded in the prophylaxis group and one in the control group. Prophylactic use of antibiotics in surgery for hip fractures seems unnecessary provided strict aseptic routines in the operating room are followed. Short-term prophylaxis against infection using cephalothin and cephalexin was studied in 140 patients operated on for trochanteric fractures of the femur. The group given the drug during preparation for anesthesia, intraoperatively, and for two days postoperatively had an infection rate of 1.8 per cent (one patient), whereas the group without prophylaxis had a rate of 16.9 per cent (twelve patients). The two groups were similar with regard to factors that may have influenced the infection rate, for example, age, time required for surgery, and blood loss. Staphylococcus aureus was the most common infecting organism, but several patients had mixed infections with intestinal bacteria. The aim of this study was to investigate the controversial issue of the use of prophylactic antibiotics in open and basilar fractures of the skull. A series of 157 patients were randomized to receive no antibiotics (group A = 46 patients) or ceftriaxone for 3 days (group B = 50 patients), or the combination ampicillin/sulphadiazine for 3 days (group C = 61 patients). The incidence of meningitis was similar in both the antibiotic and non-antibiotic groups. However, the overall incidence of infectious complications in the non-antibiotic group was significantly higher than in the antibiotic group (8.7 per cent vs 0.9 per cent, P < 0.05). There was no significant difference between the ceftriaxone group and the ampicillin/sulphadiazine group. The results of the study suggest that antibiotic prophylaxis has a role in the management of open and basilar fractures. Three hundred and seven patients, each of whom had a fracture of the proximal part of the femur, were studied in a randomized, double-blind fashion to determine whether perioperative administration of cephalothin would prevent postoperative infection. Major postoperative wound infections were significantly reduced in the cephalothin-treated group (4.7 per cent versus 0.7 per cent; p less than 0.05). There also was a reduction in the incidence of postoperative urinary-tract infections and a reduction in mean peak body temperatures. The duration of hospitalization was not affected and no hospital stay was prolonged by complications of antibiotic administration. However, in the cephalothin-treated group, a strong trend toward colonization by cephalothin-resistant organisms was noted. In 100 patients with first-, second-, and third-degree open fractures, a randomized, double-blind study was carried out to compare prophylactic cloxacillin and placebo. Prophylaxis was started preoperatively and continued for 10 days. The standard fracture treatment consisted of operative stabilization, mostly by means of plates or external fixators. In the cloxacillin group two infections were observed as compared to 12 in the control group. This difference was significant. The role of antibiotics was investigated prospectively in 91 open fractures of the finger. Antibiotics were administered to alternate patients with open phalangeal fractures. Only finger fractures distal to the metacarpophalangeal joint were included. Both groups were treated with aggressive surgical irrigation and debridement. In four patients in each group clinical signs of infection eventually developed; osteomyelitis did not develop in any patients, and no secondary surgical procedures were required in either group. This data indicates that vigorous irrigation and debridement is adequate primary treatment for open phalangeal fractures in fingers with intact digital arteries. A prospective, randomized, double-blind study was performed to evaluate the effects of antibiotic prophylaxis on the development of a wound infection in 239 patients who had immediate stabilization of a fracture of the proximal part of the femur with a dynamic hip screw. The effects of two perioperative doses of cefotiam, given twelve hours apart, were compared with those of two doses of a placebo. Sixteen perioperative risk factors were evaluated to determine whether it was possible to identify patients who were at risk for a wound infection. All patients were followed for a minimum of six weeks. Antibiotic prophylaxis significantly reduced the prevalence of wound infection (p < 0.05): the rate of major wound infection decreased from 5 to 1 per cent and the rate of minor wound infection, from 11 to 4 per cent. The most powerful predictors of major wound infection were the duration of the operation, the interval between the accident and admission to the hospital, and the duration of postoperative urinary catheterization. The preoperative level of serum albumin and the absolute lymphocyte count were significant predictors (p < 0.05) of minor wound infection and systemic infection, respectively. A prospective, double-blind, randomized, placebo-controlled study was performed to evaluate the effect of antibiotic prophylaxis in ear surgery. The present study reports on the results of 750 patients, half of whom received cefuroxime for 1 day, the other half, placebo. All postoperative infections occurring within 2 weeks after the intervention were recorded, together with several preoperative and perioperative parameters. It is concluded that exploratory tympanoplasties (including stapedotomy) and "dry perforation" tympanoplasties should be considered "clean" operations according to the American National Research Council and do not benefit from antibiotic prophylaxis. On the other hand, tympanoplasties performed on draining ears and on ears with cholesteatoma should be considered "dirty" operations for which antibiotic prophylaxis may decrease the postoperative infection rate by factor 3. All postoperative infections healed without sequels under proper treatment, except for three that resulted in graft necrosis--one in the placebo group and two in the cefuroxime group. In consequence, prophylaxis may not be mandatory in the dirty group, although the authors advocate its use for the sake of patient and surgeon comfort. A prospective trial was undertaken on 85 adult patients with open fractures of the distal phalanges of less than 6 hours duration, treated by conventional surgery. They either received no antibiotic therapy, or cephradine in short or long courses. The infection rate was 30% in the group without antibiotics and less than 3% in the treated groups. Three different antibiotics regimes were compared, with no difference in the infection rate: therefore the simplest and surest method, a single pre-operative dose and a single post-operative dose, is recommended. A prospective randomized double-blind trial was carried out to assess the effectiveness of one dose of prophylactic cefuroxime versus placebo in 502 patients who underwent surgery for a proximal femoral fracture. With an overall deep infection rate of 2.2 per cent there was no significant difference in the superficial or deep wound infection rate between the two groups. However, there was a significant reduction in the incidence of postoperative bacteriuria in the cefuroxime group. A study of three doses of cefuroxime versus placebo is now proposed. We have investigated the efficacy of intravenous antibiotic therapy as a prophylactic measure to prevent infection following low-velocity gunshot fractures. Ninety-six consecutive patients were randomized prospectively to either an antibiotic group (Group I) or a nonantibiotic group (Group II) and were followed in a special gunshot wound clinic. Only patients with fractures that could be treated by closed techniques and did not require internal fixation were included. Sixty-seven patients (73 fractures) were followed radiographically. At follow-up, 36 fractures in Group 1 and 37 fractures in Group II comprised the study group. A total of two infections, one in each group, was documented. No significant infection prophylaxis was demonstrated by the use of intravenous antibiotics in these injuries. Antibiotic prophylaxis is not routinely given for nonimplant, clean operations, although this view has recently been challenged. We have conducted a randomized multicenter, double-blind prospective trial to compare co-amoxiclav with placebo in 619 patients undergoing open groin hernia repair. Altogether 563 (91%) patients fulfilled the protocol; 283 received co-amoxiclav and 280 placebo. There was no difference between the groups in the number of patients receiving local or general anesthetic, the type of repair performed, the use of a subcutaneous fat suture, the type of skin closure used, the use of wound analgesia, or the use of a wound drain. Patients were given a card to return to the hospital in the event of their wound discharging or their needing to see their general practitioner. All patients were reviewed at approximately 6 weeks after operation. Fifty (8.9%) patients sustained a wound infection, 25 in the co-amoxiclav group and 25 in the placebo group. We conclude that antibiotic prophylaxis is of no benefit to patients undergoing open groin hernia repair. nan In a prospective randomized double-blind study of 141 patients referred for reconstructive vascular surgery on the abdominal aorta and the lower extremities, placebo was compared to antibiotic prophylaxis. The prophylaxis group received three doses of a combination of methicillin, 2 g and netilmicin, 200 mg. Antibiotic prophylaxis reduced postoperative wound infections as compared to placebo, i.e. 4/69 (5.8%) vs. 12/72, (16.7%) respectively (P = 0.04). No graft infections occurred. Two cases of postoperative septicaemia were seen in the placebo group, none in the antibiotic group. Among different procedures aortic-femoral bypass operations showed the highest wound infection rates. The two treatment groups were comparable with regard to all other postoperative complications registered, including nephro- and ototoxicity. The antibiotic regimen was considered safe, but had only marginal value as prophylaxis in vascular reconstructive surgery on the abdominal aorta and the lower extremities.
Antibiotic prophylaxis should be offered to those undergoing surgery for closed fracture fixation.