American Journal of Emergency Medicine xxx (2015) xxx–xxx

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Original Contribution

The use of prophylactic antibiotic in treatment of fingertip amputation: a randomized prospective trial☆,☆☆,★,★★ Guy Rubin, MD a,b,c,⁎, Hagay Orbach, MD a, Micha Rinott, MD a,b, Alejandro Wolovelsky, MD a,b, Nimrod Rozen, MD, PhD a,c a b c

Orthopedic Department, Ha'Emek Medical Center, Afula, Israel Hand Surgery Unit, Orthopedic Department, Ha'Emek Medical Center, Afula, Israel Faculty of Medicine, Technion, Haifa, Israel

a r t i c l e

i n f o

Article history: Received 3 January 2015 Received in revised form 1 February 2015 Accepted 1 February 2015 Available online xxxx

a b s t r a c t Purpose: Fingertip amputation is a common injury. Considerable controversy exists as to whether prophylactic antibiotics are necessary for this injury. Our goal was to compare the rate of infections among subgroups with and without prophylactic antibiotic treatment. The study hypothesis was that infection rates were similar in the 2 groups. Methods: This was a prospective randomized control trial of adult patients presenting with fingertip amputation with bone exposed, requiring surgical treatment. Patients were randomized to 2 groups: group 1 received no antibiotics, and group 2 received 1 g intravenous antibiotics (cefazolin) for 3 days. The 2 groups were matched for age, time to surgery, injury mechanism, and type of surgery. All surgical treatments were performed in the operating room, and all patients were reevaluated in our outpatient clinic after 10 days and again after a month. The primary outcome measure was the rate of infection. Results: Fifty-eight patients were initially enrolled in the study; 2 patients withdrew before study completion, 29 subjects were randomized to the no-antibiotic group, and 27 subjects were randomized to the antibiotic group. No statistically significant differences on any baseline values were found between the 2 treatment groups. There was no infection in either group at the end of follow-up. Conclusions: This study suggests that routine prophylactic antibiotics do not reduce the rate of infection after fingertip amputations with bone exposed treated surgically in the operating room. © 2015 Elsevier Inc. All rights reserved.

1. Introduction Injury to the fingertip (ie, injury distal to the insertion of the flexor and extensor tendons) is common [1]. In patients who sustain amputation of the fingertip, the nature of the injury and the physical demands of the patient should be considered when selecting a treatment method. Treatment options range from healing by secondary intention to flap coverage or replantation [2]. Prophylactic antibiotics for fingertip amputation are controversial. Although it is standard practice to use prophylactic antibiotics on grossly contaminated wounds and in immunocompromised patients, it has never been established for routine use [3,4]. The goal of the study was to compare the rate of bacterial infection among subgroups with or without antibiotic treatment in adults with ☆ All named authors hereby declare that they have no conflicts of interest to disclose. ☆☆ No benefits in any form have been received or will be received from a commercial party related directly or indirectly to the subject of this article. ★ The institutional review board approved the study before subject enrollment. ★★ This research received no specific grant from any funding agency in the public, commercial, or not-for-profit sectors. ⁎ Corresponding author. Tel.: +972 4 649 4300. E-mail address: [email protected] (G. Rubin).

distal fingertip amputations. We hypothesized that antibiotics are not warranted after debridement and repair of distal fingertip amputations in adult subjects and that infection rates are similar in patients with and without prophylactic antibiotics. 2. Patients and methods This prospective randomized control trial was conducted between May 2010 and May 2014. The institutional review board approved the study before subject enrollment. This trial is registered at ClinicalTrials.gov (NCT02077400). All adults with a fingertip amputation with bone exposed were identified prospectively at initial presentation to the emergency department (ED); and a data regarding the patient and injury were recorded including demographic data, mechanism and site of injury, time from admission to surgery, and type of surgery. Patients were excluded from the study if the patient was younger than 18 years or if the patient had diabetes, an oncological disorder, an immune deficiency, or a bleeding disorder; used steroids regularly; presented with a grossly contaminated wound or other injury requiring antibiotic treatment; was currently taking antibiotics; or had a previous allergic reaction to cephalosporins.

http://dx.doi.org/10.1016/j.ajem.2015.02.002 0735-6757/© 2015 Elsevier Inc. All rights reserved.

Please cite this article as: Rubin G, et al, The use of prophylactic antibiotic in treatment of fingertip amputation: a randomized prospective trial, Am J Emerg Med (2015), http://dx.doi.org/10.1016/j.ajem.2015.02.002

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G. Rubin et al. / American Journal of Emergency Medicine xxx (2015) xxx–xxx

Enrollment

Assessed for eligibility (n = 63)

Excluded (n = 6) ♦ Not meeting inclusion criteria (n = 3) ♦ Declined to participate (n = 3)

Randomized (n = 58)

Allocation Allocated to Antibiotic group (n = 27)

Allocated to no-Antibiotic group (n = 31)

♦ Received

♦ Received

allocated intervention (n = 27)

allocated intervention (n = 31)

Follow-Up Lost to follow-up (give reasons) (n = 0)

Lost to follow-up (unwilling to return) (n = 2)

Discontinued intervention (n = 0)

Discontinued intervention (n = 0)

Analysis Analysed (n = 27)

Analysed (n = 29)

♦ Excluded

♦ Excluded

from analysis (n = 0)

from analysis (n = 0)

Figure. Consolidated Standards of Reporting Trials [6] flow diagram.

After informed consent was obtained in the ED, participants were randomized to 1 of 2 groups using an online randomization program. Subjects assigned to group 1 received no antibiotics. Group 2 received parenteral prophylactic antibiotics (cefazolin, 1 g, 3 times daily) for 3 days. The first course was given in the ED. All patients were admitted to our department. All wounds were treated in the operating room. Follow-up visits were scheduled at 10 and 30 days. At follow-up, the wound was inspected for signs of infection. Infection was defined using clinical parameters of erythema, pain, swelling, wound discharge, or presence of pus or cellulitis. Analyses of demographic and clinical patient characteristics by study arm were made using Wilcoxon 2-sample test for continuous variables, and χ2 tests or Fisher exact tests for categorical data. Statistical significance was set at P b .05. Statistical analysis was performed with the SAS (Cary, NC) 9.2 software. For the purpose of our study, it was assumed that the infection rate for patients with a fingertip amputation not treated with antibiotic was 30% and the infection rate for those treated with an antibiotic was 1% [5]. To achieve 80% power with α 5% (2-sided test), 27 patients were recruited in each study arm.

3. Results During the study period, 63 adult patients presented to the ED who met the inclusion criteria and signed the informed consent form. The recruitment process for these patients is listed in the Consolidated Standards of Reporting Trials flow diagram (Figure) [6]. Fifty-eight patients with 60 finger injuries were randomized. The Table demonstrates that randomization of patients to the 2 groups was effective. This is confirmed by the Wilcoxon 2-sample test for continuous variables, and χ2 tests or Fisher exact tests for categorical data, which show no significant difference (P N .05) between the samples in terms of sex, age, involved finger, mechanism of injury, time to operation, and type of surgery. Overall, there were no infections in both groups (antibiotic group 0%

[95% confidence interval, 0%-12.5%] and no antibiotic group 0% [95% confidence interval, 0%-11.7%]). 4. Discussion De Alwis [7] performed a literature review and found no randomized controlled trials (RCTs) that looked specifically at prophylactic use of antibiotics for soft tissue injuries of fingertips. However, this has been studied for soft tissue injuries of the hand. In 1 RCT conducted on patients with clean incised wounds on fingers and thumb (n = 104) and palm and wrist (n = 40), there was a nonsignificant trend in decreasing rate of infection when prophylactic antibiotics were used (4% infection rate with a 5-day course of prophylactic antibiotics vs 13% with an inadequate course vs 15% with no antibiotics) [8]. Haughey et al [9] investigated a total of 394 patients with hand soft tissue injury. They were randomly assigned to 1 of 2 treatment groups: those receiving cephalexin (250 mg orally qid × 5 days) and the control group receiving no antibiotic. There was no statistical difference in the incidence of infection in the 2 groups. Two studies examined the need for prophylactic antibiotics in different types of complex hand injuries but found it not necessary for infection prevention [10,11]. The routine use of prophylactic antibiotics for open fractures of the distal phalanx is controversial, with studies showing conflicting results. One RCT showed a significant increase in infection rate without antibiotics compared to patients who had antibiotics (30% vs 2.7%) [5]. Another RCT revealed no significant difference in the infection rate following prophylactic flucloxacillin for open fractures of the distal phalanx in addition to meticulous wound cleaning [12]. Similar nonsignificant results were obtained for the antibiotic-treated group in another controlled trial involving patients with all open finger fractures who had aggressive wound debridement and irrigation [13]. This study is the first to address the need for prophylactic antibiotic in adult fingertip amputation with bone exposed. In this study, we found no infection; and we attribute this result to the rarity of infection

Please cite this article as: Rubin G, et al, The use of prophylactic antibiotic in treatment of fingertip amputation: a randomized prospective trial, Am J Emerg Med (2015), http://dx.doi.org/10.1016/j.ajem.2015.02.002

G. Rubin et al. / American Journal of Emergency Medicine xxx (2015) xxx–xxx

most important factor in preventing infection in adult, healthy patients without grossly contaminated fingertip amputation.

Table Comparative data showing effective randomization between the 2 groups

Sex Male Female Age, y (average) Finger 1 2 3 4 5 Mechanism of injury Crush Cut Time to operation (h) Type of operation Trimming Cross finger flap V-Y flap

No-antibiotic group

Antibiotic group

(n = 29)

(n = 27/29 fingers)

P

References 1

27 (93%) 2 (7%) 40 (18-63)

26 (96%) 1 (4%) 40 (18-67)

3 (10%) 12 (41%) 7 (24%) 3 (10%) (14%) 4

5 (17%) 6 (21%) 10 (35%) 6 (20%) 2 (7%)

(69%) 20 9 (31%) 11.5 (2-27)

14 (52%) 13 (48%) 14.5 (2-56)

.9444 .1237

.3224

11 (38%) 1 (3%) 17 (59%)

3

.9288 .1098

17 (63%) 1 (4%) 9 (33%)

Continuous variables are presented with mean (range), and categorical variables are presented with frequencies and percentages.

in this kind of injury, the small sample size, and the fact that all wounds were treated by debridement, irrigation, and rapid primary repair in an operating room environment. This study reinforce the common belief [3,4,7,10,11,13,14] that early meticulous wound care appears to be the

[1] Lee DH, Mignemi ME, Crosby SN. Fingertip injuries: an update on management. J Am Acad Orthop Surg 2013;21(12):756–66. [2] Muneuchi G, Tamai M, Igawa K, Kurokawa M, Igawa HH. The PNB classification for treatment of fingertip injuries: the boundary between conservative treatment and surgical treatment. Ann Plast Surg 2005;54(6):604–9. [3] Jebson P, Louis D, Bagg M. Amputations. Green's operative hand surgery6th ed. . Philadelphia, PA: Elsevier/Churchill Livingstone; 2011 1887. [4] Lamon RP, Cicero JJ, Frascone RJ, Hass WF. Open treatment of fingertip amputations. Ann Emerg Med 1983;12(6):358–60. [5] Sloan JP, Dove AF, Maheson M, Cope AN, Welsh KR. Antibiotics in open fractures of the distal phalanx? J Hand Surg (Br) 1987;12(1):123–4. [6] Moher D, Hopewell S, Schulz KF, Montori V, Gotzsche PC, Devereaux PJ, et al. CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials. BMJ 2010;340:c869. [7] de Alwis W. Fingertip injuries. Emerg Med Australas 2006;18(3):229–37. [8] Whittaker JP, Nancarrow JD, Sterne GD. The role of antibiotic prophylaxis in clean incised hand injuries: a prospective randomized placebo controlled double blind trial. J Hand Surg (Br) 2005;30(2):162–7. [9] Haughey RE, Lammers RL, Wagner DK. Use of antibiotics in the initial management of soft tissue hand wounds. Ann Emerg Med 1981;10(4):187–92. [10] Drew PJ, Titley OG. Use of antibiotics after complex open hand injury. Br J Clin Pract 1995;49(6):297–300. [11] Peacock KC, Hanna DP, Kirkpatrick K, Breidenbach WC, Lister GD, Firrell J. Efficacy of perioperative cefamandole with postoperative cephalexin in the primary outpatient treatment of open wounds of the hand. J Hand Surg [Am] 1988;13(6):960–4. [12] Stevenson J, McNaughton G, Riley J. The use of prophylactic flucloxacillin in treatment of open fractures of the distal phalanx within an accident and emergency department: a double-blind randomized placebo-controlled trial. J Hand Surg (Br) 2003;28(5):388–94. [13] Suprock MD, Hood JM, Lubahn JD. Role of antibiotics in open fractures of the finger. J Hand Surg [Am] 1990;15(5):761–4. [14] Fassler PR. Fingertip injuries: evaluation and treatment. J Am Acad Orthop Surg 1996;4(1):84–92.

Please cite this article as: Rubin G, et al, The use of prophylactic antibiotic in treatment of fingertip amputation: a randomized prospective trial, Am J Emerg Med (2015), http://dx.doi.org/10.1016/j.ajem.2015.02.002

The use of prophylactic antibiotics in treatment of fingertip amputation: a randomized prospective trial.

Fingertip amputation is a common injury. Considerable controversy exists as to whether prophylactic antibiotics are necessary for this injury. Our goa...
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