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Efficacy of preoperative home use of 2% chlorhexidine gluconate cloth before shoulder surgery
J Shoulder Elbow Surg (2011) 20, 928-933
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Efficacy of preoperative home use of 2% chlorhexidine gluconate cloth before shoulder surgery Michael R. Murray, MD*, Matthew D. Saltzman, MD, Stephen M. Gryzlo, MD, Michael A. Terry, MD, Chase C. Woodward, BS, Gordon W. Nuber, MD Department of Orthopaedic Surgery, Northwestern University, Chicago, IL, USA Hypothesis: Deep infection after shoulder surgery is a rare but devastating problem. This study tested the hypothesis that the home application of a 2% chlorhexidine gluconate cloth before shoulder surgery would be more efficacious than a standard shower of soap and water at decreasing the preoperative cutaneous levels of pathogenic bacteria on the shoulder. Materials and methods: This randomized, prospective study evaluated 100 consecutive patients undergoing shoulder surgery. Patients were randomly assigned to use 2% chlorhexidine gluconateeimpregnated cloths (treatment group) or to shower with soap and water before surgery (control group). Cutaneous cultures were taken from the patients’shoulders in the preoperative holding area. Patients were monitored for 2 months postoperatively for clinical signs of infection. Results: In the treatment group vs the control group, the overall positive culture rate was 66% vs 94% (P ¼ .0008), and the positive culture rate for coagulase-negative Staphylococcus was 30% vs 70% (P ¼ .0001). The positive culture rate for Propionibacterium acnes was 46% in the treatment group vs 58% in the control group (P ¼ .32). No infections occurred in any patients at a minimum of 2-months after surgery. Discussion: The use of the 2% chlorhexidine cloth was effective at decreasing overall bacterial culture rates before shoulder surgery and was particularly effective at decreasing the quantity of coagulase-negative Staphylococcus, a known causative agent of postoperative shoulder infections. Conclusion: Use of chlorhexidine impregnated cloths prior to shoulder surgery may be a useful adjunct to presently used infection prevention strategies. Level of evidence: Level I, Randomized Controlled Trial, Treatment Study. Ó 2011 Journal of Shoulder and Elbow Surgery Board of Trustees. Keywords: Chlorhexidine; P acnes; infection; Staphylococcus
Infection after shoulder surgery is a devastating event that typically results in functional deficit and patient dissatisfaction.1,14,16 Fortunately, the rate of infection after This study is registered at ClinicalTrials.gov: ID NCT01090479. This study received Investigational Review Board (IRB) approval from the Office for the Protection of Research Subjects at Northwestern University (IRB Project Number: STU00012486). *Reprint requests: Michael R. Murray, MD, 676 N St. Clair, Ste 1350, Chicago, IL 60610 USA. E-mail address: [email protected] (M.R. Murray).
shoulder surgery is relatively low, with lower reported rates after arthroscopic procedures than after shoulder arthroplasty.1,2,5-8,14,15,18,19 Although deep infection after shoulder surgery can often be eradicated, patients often require multiple procedures and are frequently left with significant functional deficits.1,14,16 The use of perioperative prophylactic antibiotics and aseptic technique have been shown to reduce postoperative infection rates.12 Recently, presurgical skin preparation with ChloraPrep (2% chlorhexidine gluconate and 70%
1058-2746/$ - see front matter Ó 2011 Journal of Shoulder and Elbow Surgery Board of Trustees. doi:10.1016/j.jse.2011.02.018
Use of 2% chlorhexidine cloth before shoulder surgery isopropyl alcohol; Enturia, El Paso, Texas, USA) was shown to be more efficacious than DuraPrep (0.7% iodophor and 74% isopropyl alcohol, 3M Healthcare, St. Paul, MN, USA) and Betadine (Purdue Frederick Co, Norwalk, CT, USA) at eliminating bacteria from the skin before shoulder surgery.13 Because most postoperative shoulder infections are caused by native skin flora,1,8,14 a protocol of home skin preparation may be a useful step in decreasing the cutaneous bacterial pathogens and ultimately preventing postoperative infection. We hypothesized that the home use of 2% chlorhexidine gluconateeimpregnated cloths would be more efficacious than a standard soap-and-water shower at decreasing the preoperative cutaneous levels of pathogenic bacteria on the shoulder.
Methods Between January 2010 and May 2010, 100 consecutive patients undergoing shoulder surgery were enrolled in this prospective randomized study. Our inclusion criteria were patients scheduled for any type of shoulder surgery. Patients were excluded if they refused to participate, had an open wound, a current infection, or a chronic immunosuppressive condition. Four patients were excluded: 3 refused to participate, and 1 patient had agammaglobulinemia, a chronic immunosuppressive condition. All participating patients provided informed consent. All procedures were performed at a single institution by 1 of 4 attending surgeons (G.W.N., S.M.G., M.D.S., M.A.T.). Sealed envelopes were used to randomly assign patients to use of 2% chlorhexidine gluconate cloths (Sage Products, Cary, IL, USA) around the shoulder or to a standard shower with soap and water. The surgeons were blinded to which treatment group each patient had been assigned.
Treatment protocol Patients assigned to the treatment group were mailed 2 sets of 2% chlorhexidine gluconateeimpregnated cloths. These patients were instructed to shower with soap and water the evening before their operation and to wipe their entire operative extremity, including the axilla, shoulder, and ipsilateral chest and back, with a 2% chlorhexidine gluconateeimpregnated cloth 1 hour after showering. The morning of surgery, patients in the treatment group were instructed to avoid showering and to apply a second 2% chlorhexidine gluconateeimpregnated cloth in the same manner as the first within 2 hours of departing for the hospital. Patients assigned to the control group were instructed to shower with soap and water the morning of surgery.
Patients Upon arrival at the preoperative holding area, the patients completed a questionnaire that included age, ability to complete the preoperative cleansing protocol, the occurrence of adverse reactions to the chlorhexidine gluconate cloths, whether they were heavy smokers (>1.5 packs/d), had diabetes mellitus, were taking immunosuppressive medications, were taking antibiotics, or had shaved their axilla before surgery.
929
Bacterial sampling and culture analysis While patients were in the preoperative holding area, cutaneous swabs were taken for qualitative anaerobic and aerobic culture from the posterior shoulder (2 cm inferior and 1 cm medial to the posterolateral border of the acromion) and from the axilla. Next, a quantitative blood agar plate (Remel, Lenexa, KS, USA) was placed in contact with the posterior shoulder. The microbiology department at our institution analyzed the samples and was blinded to the treatment. The samples were maintained for 7 days to monitor for growth of Propionibacterium acnes based on a reported average incubation period of 5.1 days to isolate this organism.17 As a control for possible false-positive results from the microbiologic analysis, we sent 7 aerobic, 7 anaerobic, and 7 blood agar plates for analysis after exposing the swab or plate to room air.
Antibiotic prophylaxis Preoperative antibiotics of (1 gram of cefazolin if weight was <90 kg and 2 grams if weight was >90 kg, or 900 mg of clindamycin, if allergic to penicillin) were administered to all 100 patients within 1 hour of the skin incision. Patients undergoing shoulder arthroplasty received the same protocol, with the addition of 1 gram of vancomycin, which is the standard protocol for joint arthroplasty at our institution. An antibacterial-impregnated barrier (Ioban, 3M Healthcare, St. Paul, MN, USA) was used for all cases that involved the implantation of a prosthesis, as this is the standard practice of the surgeons involved with this study who perform shoulder arthroplasty. Intraoperatively, each shoulder was prepared with ChloraPrep (2% chlorhexidine gluconate and 70% isopropyl alcohol; Enturia, El Paso, TX, USA), as is the standard practice for each of the attending surgeons involved in the study. All cultures were obtained before preparation of the skin and placement of barrier drapes occurred.
Detection of clinical infection Patients were monitored prospectively for possible development of infection for a 2-month period after their operation. The attending surgeons who performed the postoperative clinical surveillance for infection were blinded to the treatment arm that their patients had been allocated to.
Statistical analysis An a priori sample size calculation of 45 patients per group had 80% power to detect at least a 30% difference in positive organisms between groups. This difference has been considered to be clinically significant, using a two-tailed test and a type I error rate of 5%.9 The actual sample size of 50 patients per group had 80% power to detect a 28% difference. All statistical comparisons between groups were on an intentto-treat basis. Clinical characteristics were compared between groups using the Wilcoxon rank sum test for age or the Fisher exact test for other dichotomous variables. Posterior and axilla qualitative measures were each compared between the treatment
930 Table I
M.R. Murray et al. Patient characteristics
Variable) Age, years Sex (M/F) Smoker (>1.5 PPD) Diabetes mellitus Immunosuppressive medications Taking antibiotics Shaved axilla Type of surgery Open Arthroscopic Compliance with protocol Side effects
Control
Chlorhexidine
(n ¼ 50)
(n ¼ 50)
52.0 16.7 25/25 (50% male) 1 (2) 4 (8) 0 (0) 0 (0) 12 (24)
49.0 16.2 36/14 (72% male) 1 (2) 4 (8) 1 (2) 1 (2) 8 (16)
8 42 50/50 (100) 0 (0)
6 44 45/50 (90) 12 (24)
P .14 .04y >.99 >.99 .99 .99 .45 .77
.056 .0002
PPD, packs per day. ) Data are expressed as number (%), except where noted. y Statistically significant (P < .05).
(2% chlorhexidine gluconateeimpregnated cloths) and control (standard soap-and-water shower) groups using the Fisher exact test. Quantitative counts in positive cases were compared between groups using the Wilcoxon rank sum test. All tests were 2-tailed. All statistical analyses were performed by an independent statistician using OnlineDoc 9.2 (SAS Institute Inc,Cary, NC, USA).
Results Patient characteristics are summarized in Table I. The study included 61 men and 39 women, and the patient ages ranged from 19 to 86 years. Men comprised 36 of 50 patients (72%) in the treatment group and 25 of 50 patients (50%) in the control group (P ¼ .04). The treatment group underwent 44 entirely arthroscopic surgeries and 6 open surgeries (6 primary total shoulder arthroplasties). The control group underwent 42 arthroscopic surgeries and 8 open surgeries (P ¼ .77 compared with control), comprising 6 primary total shoulder arthroplasties, 1 revision total shoulder arthroplasty, and 1 open Weaver-Dunn procedure. There were no acute trauma patients in this study. In the control group, there was 1 heavy smoker (>1.5 packs/d), 4 patients had diabetes mellitus, and 8 patients had shaved their axilla before surgery. In the treatment group, there was 1 heavy smoker (>1.5 packs/d), 4 patients had diabetes mellitus, 1 patient had taken an immunosuppressive medication (10 mg of prednisone daily), 1 patient had taken amoxicillin for an upper respiratory infection, and 6 patients reported shaving their axilla before surgery. No serious adverse effects occurred in any patients. However, a questionnaire revealed that 24% of patients in the treatment group reported mild itching or a feeling of dry skin after application of the 2% chlorhexidine gluconatee impregnated cloths. No surgical procedures were cancelled secondary to problems pertaining to the skin.
Of the 50 patients in the treatment group, 45 (90%) reported complete compliance with instructions for home application of the 2% chlorhexidine gluconatee impregnated cloth. Five patients reported incomplete compliance with the protocol: 4 patients were unable to elevate their arm sufficiently to apply the cloth to their axilla, and 1 patient showered in between applications of the 2% chlorhexidine gluconateeimpregnated cloths. The overall positive culture rate for all bacteria at both sites (combined posterior shoulder and axillary cultures) was 66% in the treatment group compared with 94% in the control group (P ¼ .0008). The positive culture rate for coagulase-negative Staphylococcus was 30% in the treatment group compared with 70% in the control group (P ¼ .0001). The positive culture rate for Corynebacterium was 8% in the treatment group compared with 28% in the control group (P ¼ .017). The positive culture rate for P acnes was 46% in the treatment group compared with 58% in the control group (P ¼ .32; Table II; Fig. 1). For the posterior shoulder site, the positive culture rate was 50% in the treatment group vs 74% in the control group (P ¼ .023). The positive culture rate for coagulasenegative Staphylococcus was 10% in the treatment group compared with 50% in the control group (P < .0001). The positive-culture rate for Corynebacterium was 0% in the treatment group compared with 12% in the control group (P ¼ .027). The positive culture rate for P acnes was 40% in both groups (Table III). For the axilla, the positive culture rate was 42% in the treatment group and 78% in the control group (P ¼ .0005). The positive culture rate for coagulase-negative Staphylococcus was 22% in the treatment group compared with 60% in the control group (P ¼ .0002). The positive culture rate for P acnes was 24% in the treatment group compared with 30% in the control group (P ¼ .65; Table III).
Use of 2% chlorhexidine cloth before shoulder surgery Table II
Rate of positive cultures from entire shoulder region (combined from axilla and posterior shoulder)
Organism
All organisms Coagulase-negative Staphylococcus Propionibacterium acnes Corynebacterium Gram-negative bacilli Micrococcus Peptostreptococcus Clostridium Staphylococcus aureus Lactobacillus Enterococcus Bifidobacterium Staphylococcus warneri b-Hemolytic Streptococcus Eubacterium
Control
Chlorhexidine
(n ¼ 50)
(n ¼ 50)
No. (%)
No. (%)
47 35 29 14 7 5 2 2 3 2 0 1 0 0 1
33 15 23 4 4 0 2 2 0 0 1 0 1 1 0
(94) (70) (58) (28) (14) (10) (4) (4) (6) (4) (0) (2) (0) (0) (2)
P
.0008) .0001) .32 .017) .52 .057 >.99 >.99 .24 .49 .99 .99 .99 .99 .99
(66) (30) (46) (8) (8) (0) (4) (4) (0) (0) (2) (0) (2) (2) (0)
Statistically significant (P < .05).
Quantitative bacterial cultures positive for bacterial growth were analyzed for the number of bacterial colonies/ cm2. Median values of colonies/cm2 were 0.11 in the treatment group and 0.35 in the control group for coagulase-negative Staphylococcus (P ¼ .002), 0.035 in the treatment group and 0.071 colonies/cm2 in the control group for gram-negative bacilli (P ¼ .017), 0.071 in the treatment group and 0.25 in the control group for Corynebacterium (P ¼ .73), and 0.035 in the treatment group and 0.32 in the control group for Micrococcus (P ¼ .019). P acnes did not grow at a sufficient level from the quantitative cultures to provide a comparison between the treatment and control groups (Table IV). To evaluate for possible false-positive culture rates, we exposed 7 qualitative anaerobic swabs, 7 qualitative aerobic swabs, and 7 contact blood agar quantitative plates to room air for approximately 20 seconds. These specimens were processed and analyzed in the same fashion as the other specimens. At the end of 7 days, none of the specimens displayed any bacterial growth.
Discussion Fortunately, deep infection is a relatively rare event after shoulder surgery, with reported rates of 0.006% to 3.4% after arthroscopy,2,3,12,18 0.27% to 1.9% after open rotator cuff repair,1,5-8,14 and 0% and 3.9 % after unconstrained shoulder arthroplasty.15,19 Patients who experience infection after shoulder surgery are often dissatisfied with their outcome and can experience significant morbidity if multiple procedures are required in addition to the index operation.6,8
% positive
)
931
100 90 80 70 60 50 40 30 20 10 0
Control
Treatment
Organism
Figure 1 Rate of positive qualitative cultures for overall shoulder area (posterior and axilla).
The present study is in agreement with other studies that have found coagulase-negative Staphylococcus and P acnes, to be the most commonly isolated organisms from the shoulder region.10,13 As far as we know, the current study is the first to use quantitative cultures around the shoulder after preparation of this region for surgery. We were able to demonstrate a 3-fold lower colony count for coagulase-negative Staphylococcus when chlorhexidine gluconateeimpregnated cloths were used compared with a standard shower with soap and water. Although we did not observe a significant reduction in P acnes, a trend toward lower positive culture rate of 46% was noted in the treatment group compared with 58% in the control group (P ¼ .32). There were 36 men in the treatment group vs 25 men in the control group (P ¼ .04), which may have influenced our results as men have higher rates of
932
M.R. Murray et al.
Table III
Rate of positive qualitative cultures from posterior shoulder site and axilla
Organism
Posterior, No. (%)
All organisms Coagulase-negative Staphylococcus Propionibacterium acnes Corynebacterium Micrococcus Gram-negative bacilli Peptostreptococcus Clostridium Staphylococcus aureus Enterococcus Bifidobacterium Lactobacillus Staphylococcus warneri b-Hemolytic Streptococcus Eubacterium
Axilla, No. (%)
Control
Chlorhexidine
(n ¼ 50)
(n ¼ 50)
P
37 (74) 25 (50)
25 (50) 5 (10)
.023) <.0001)
20 6 4 3 1 2 0 0 1 0 0 0 0
20 0 0 1 2 1 0 1 0 0 1 0 0
>.99 .027) .12 .62 .99 .99 NT .99 >.99 NT .99 NT NT
(40) (12) (8) (6) (2) (4) (0) (0) (2) (0) (0) (0) (0)
(40) (0) (0) (2) (4) (2) (0) (2) (0) (0) (2) (0) (0)
Control
Chlorhexidine
(n ¼ 50)
(n ¼ 50)
39 (78) 30 (60)
21 (42) 11 (22)
15 10 1 5 1 0 3 0 0 2 0 0 1
12 4 0 3 1 1 0 0 0 0 0 1 0
(30) (20) (2) (10) (2) (0) (6) (0) (0) (4) (0) (0) (2)
(24) (8) (0) (6) (2) (2) (0) (0) (0) (0) (0) (2) (0)
P .0005) .0002) .65 .15 .99 .72 >.99 .99 .24 NT NT .49 NT .99 .99
NT, no statistical test was done because all frequencies were 0. ) Statistically significant (P < .05).
Table IV
Median number of colony counts per cm2
Organism Coagulase-negative Staphylococcus Gram-negative bacilli Micrococcus Corynebacterium )
Control
Chlorhexidine
P
Count
No. Count
No.
0.35
49
0.11
20
.002)
0.071 0.32 0.25
18 20 25
0.035 0.035 0.071
5 3 3
.017) .019) .73
Statistically significant (P < .05).
colonization with P acnes than women.10 Because no infections occurred during the course of this study, we do not know whether reduction in bacterial loads will translate into lower infection rates after shoulder surgery. Several studies have found that chlorhexidine-based skin preparation solutions decrease positive culture rates13,15 and surgical site infections,4,9,13 but the role of chlorhexidine gluconateeimpregnated cloths has not been as rigorously evaluated. We previously reported that a chlorhexidine-based skin preparation solution is more efficacious than povidonebased products at eliminating bacteria from the shoulder.13 Popovich et al11 demonstrated that daily skin cleansing with 2% chlorhexidine gluconate cloths resulted in a significantly decreased rate of central venous catheter-associated bloodstream infections compared with daily washing with soap and water.11 The present study is the first study to evaluate the efficacy of 2% chlorhexidine gluconatee impregnated cloths before shoulder surgery.
Our study had several important limitations. First, we examined positive culture rates and did not directly examine infection rates. Because infection is relatively rare after shoulder surgery, a much larger patient population would be necessary to directly evaluate infection rates. Second, we did not obtain cultures after the skin had been prepared for surgery, thus we do not know if there is a synergistic effect of using 2% chlorhexidine gluconateeimpregnated washcloths along with intraoperative skin preparation with a chlorhexidine-based agent. Financial constraints precluded us from being able to take a second set of cultures after surgical skin preparation in the operating room. Third, the manufacturer of the 2% chlorhexidine gluconateeimpregnated cloths provided the funding for this study. This funding was used exclusively for microbiology expenses, and the manufacturer was not involved with study organization, data analysis, or writing of the manuscript.
Conclusion We were able to demonstrate a significant reduction in the overall bacterial load around the shoulder, including coagulase-negative Staphylococcus, a pathogen known to cause postoperative shoulder infections,1,8,14 when chlorhexidine cloths were used compared with a standard shower with soap and water. The potential benefit of chlorhexidine-impregnated cloths for skin preparation comes at a relatively low cost of approximately $3 per
Use of 2% chlorhexidine cloth before shoulder surgery package of two 2% chlorhexidine gluconateeimpregnated cloths, and its use appears relatively safe. Use of chlorhexidine-impregnated cloths before shoulder surgery may be a useful adjunct to other presently used infection prevention strategies.
Disclaimer External funding of this study was obtained from Sage Products Inc (Cary, IL, USA), the company that manufactures the 2% chlorhexidine gluconateeimpregnated cloths. This funding was used exclusively for microbiology expenses, and the company was not involved with the study design, analysis of the data, or writing of this manuscript. A grant of $32,000 was received from Sage Products Inc as a research grant to Northwestern University.
References 1. Athwal GS, Sperling JW, Rispoli DM, Cofield RH. Deep infection after rotator cuff repair. J Shoulder Elbow Surg 2007;16:306-11. doi: 10.1016/j.jse.2006.05.013 2. Brislin KJ, Field LD, Savoie FH 3rd. Complications after arthroscopic rotator cuff repair. Arthroscopy 2007;23:124-8. doi:10.1016/j.arthro. 2006.09.001 3. D’Angelo GL, Ogilvie-Harris DJ. Septic arthritis following arthroscopy, with cost/benefit analysis of antibiotic prophylaxis. Arthroscopy 1988;4:10-4. 4. Darouiche RO, Wall MJ Jr, Itani KM, Otterson MF, Webb AL, Carrick MM, et al. Chlorhexidine-alcohol versus povidone-iodine for surgical-site antisepsis. N Engl J Med 2010;362:18-26. doi:10.1056/ NEJMoa0810988
933 5. Herrera MF, Bauer G, Reynolds F, Wilk RM, Bigliani LU, Levine WN. Infection after mini-open rotator cuff repair. J Shoulder Elbow Surg 2002;11:605-8. doi:10.1067/mse.2002.127302 6. Kwon YW, Kalainov DM, Rose HA, Bisson LJ, Weiland AJ. Management of early deep infection after rotator cuff repair surgery. J Shoulder Elbow Surg 2005;14:1-5. doi:10.1016/j.jse.2004.04.010 7. Mansat P, Cofield RH, Kersten TE, Rowland CM. Complications of rotator cuff repair. Orthop Clin North Am 1997;28:205-13. 8. Mirzayan R, Itamura JM, Vangsness CT Jr, Holtom PD, Sherman R, Patzakis MJ. Management of chronic deep infection following rotator cuff repair. J Bone Joint Surg Am 2000;82:1115-21. 9. Ostrander RV, Botte MJ, Brage ME. Efficacy of surgical preparation solutions in foot and ankle surgery. J Bone Joint Surg Am 2005;87: 980-5. doi:10.2106/JBJS.D.01977 10. Patel A, Calfee RP, Plante M, Fischer SA, Green A. Propionibacterium acnes colonization of the human shoulder. J Shoulder Elbow Surg 2009;18:897-902. doi:10.1016/j.jse.2009.01.023 11. Popovich KJ, Hota B, Hayes R, Weinstein RA, Hayden MK. Effectiveness of routine patient cleansing with chlorhexidine gluconate for infection prevention in the medical intensive care unit. Infect Control Hosp Epidemiol 2009;30:959-63. doi:10.1086/605925 12. Randelli P, Castagna A, Cabitza F, Cabitza P, Arrigoni P, Denti M. Infectious and thromboembolic complications of arthroscopic shoulder surgery. J Shoulder Elbow Surg 2010;19:97-101. doi:10. 1016/j.jse.2009.04.009 13. Saltzman MD, Nuber GW, Gryzlo SM, Marecek GS, Koh JL. Efficacy of surgical preparation solutions in shoulder surgery. J Bone Joint Surg Am 2009;91:1949-53. doi:10.2106/JBJS.H.00768 14. Settecerri JJ, Pitner MA, Rock MG, Hanssen AD, Cofield RH. Infection after rotator cuff repair. J Shoulder Elbow Surg 1999;8:1-5. 15. Sperling JW, Kozak TK, Hanssen AD, Cofield RH. Infection after shoulder arthroplasty. Clin Orthop Relat Res 2001:206-16. 16. Strickland JP, Sperling JW, Cofield RH. The results of two-stage reimplantation for infected shoulder replacement. J Bone Joint Surg Br 2008;90:460-5. doi:10.1302/0301-620X.90B4.20002 17. Topolski MS, Chin PY, Sperling JW, Cofield RH. Revision shoulder arthroplasty with positive intraoperative cultures: the value of preoperative studies and intraoperative histology. J Shoulder Elbow Surg 2006;15:402-6. doi:10.1016/j.jse.2005.10.001 18. Weber SC, Abrams JS, Nottage WM. Complications associated with arthroscopic shoulder surgery. Arthroscopy 2002;18(2 suppl 1):88-95. 19. Wirth MA, Rockwood CA Jr. Complications of shoulder arthroplasty. Clin Orthop Relat Res 1994:47-69.
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Efficacy of preoperative home use of 2% chlorhexidine gluconate cloth before shoulder surgery Michael R. Murray, MD*, Matthew D. Saltzman, MD, Stephen M. Gryzlo, MD, Michael A. Terry, MD, Chase C. Woodward, BS, Gordon W. Nuber, MD Department of Orthopaedic Surgery, Northwestern University, Chicago, IL, USA Hypothesis: Deep infection after shoulder surgery is a rare but devastating problem. This study tested the hypothesis that the home application of a 2% chlorhexidine gluconate cloth before shoulder surgery would be more efficacious than a standard shower of soap and water at decreasing the preoperative cutaneous levels of pathogenic bacteria on the shoulder. Materials and methods: This randomized, prospective study evaluated 100 consecutive patients undergoing shoulder surgery. Patients were randomly assigned to use 2% chlorhexidine gluconateeimpregnated cloths (treatment group) or to shower with soap and water before surgery (control group). Cutaneous cultures were taken from the patients’shoulders in the preoperative holding area. Patients were monitored for 2 months postoperatively for clinical signs of infection. Results: In the treatment group vs the control group, the overall positive culture rate was 66% vs 94% (P ¼ .0008), and the positive culture rate for coagulase-negative Staphylococcus was 30% vs 70% (P ¼ .0001). The positive culture rate for Propionibacterium acnes was 46% in the treatment group vs 58% in the control group (P ¼ .32). No infections occurred in any patients at a minimum of 2-months after surgery. Discussion: The use of the 2% chlorhexidine cloth was effective at decreasing overall bacterial culture rates before shoulder surgery and was particularly effective at decreasing the quantity of coagulase-negative Staphylococcus, a known causative agent of postoperative shoulder infections. Conclusion: Use of chlorhexidine impregnated cloths prior to shoulder surgery may be a useful adjunct to presently used infection prevention strategies. Level of evidence: Level I, Randomized Controlled Trial, Treatment Study. Ó 2011 Journal of Shoulder and Elbow Surgery Board of Trustees. Keywords: Chlorhexidine; P acnes; infection; Staphylococcus
Infection after shoulder surgery is a devastating event that typically results in functional deficit and patient dissatisfaction.1,14,16 Fortunately, the rate of infection after This study is registered at ClinicalTrials.gov: ID NCT01090479. This study received Investigational Review Board (IRB) approval from the Office for the Protection of Research Subjects at Northwestern University (IRB Project Number: STU00012486). *Reprint requests: Michael R. Murray, MD, 676 N St. Clair, Ste 1350, Chicago, IL 60610 USA. E-mail address: [email protected] (M.R. Murray).
shoulder surgery is relatively low, with lower reported rates after arthroscopic procedures than after shoulder arthroplasty.1,2,5-8,14,15,18,19 Although deep infection after shoulder surgery can often be eradicated, patients often require multiple procedures and are frequently left with significant functional deficits.1,14,16 The use of perioperative prophylactic antibiotics and aseptic technique have been shown to reduce postoperative infection rates.12 Recently, presurgical skin preparation with ChloraPrep (2% chlorhexidine gluconate and 70%
1058-2746/$ - see front matter Ó 2011 Journal of Shoulder and Elbow Surgery Board of Trustees. doi:10.1016/j.jse.2011.02.018
Use of 2% chlorhexidine cloth before shoulder surgery isopropyl alcohol; Enturia, El Paso, Texas, USA) was shown to be more efficacious than DuraPrep (0.7% iodophor and 74% isopropyl alcohol, 3M Healthcare, St. Paul, MN, USA) and Betadine (Purdue Frederick Co, Norwalk, CT, USA) at eliminating bacteria from the skin before shoulder surgery.13 Because most postoperative shoulder infections are caused by native skin flora,1,8,14 a protocol of home skin preparation may be a useful step in decreasing the cutaneous bacterial pathogens and ultimately preventing postoperative infection. We hypothesized that the home use of 2% chlorhexidine gluconateeimpregnated cloths would be more efficacious than a standard soap-and-water shower at decreasing the preoperative cutaneous levels of pathogenic bacteria on the shoulder.
Methods Between January 2010 and May 2010, 100 consecutive patients undergoing shoulder surgery were enrolled in this prospective randomized study. Our inclusion criteria were patients scheduled for any type of shoulder surgery. Patients were excluded if they refused to participate, had an open wound, a current infection, or a chronic immunosuppressive condition. Four patients were excluded: 3 refused to participate, and 1 patient had agammaglobulinemia, a chronic immunosuppressive condition. All participating patients provided informed consent. All procedures were performed at a single institution by 1 of 4 attending surgeons (G.W.N., S.M.G., M.D.S., M.A.T.). Sealed envelopes were used to randomly assign patients to use of 2% chlorhexidine gluconate cloths (Sage Products, Cary, IL, USA) around the shoulder or to a standard shower with soap and water. The surgeons were blinded to which treatment group each patient had been assigned.
Treatment protocol Patients assigned to the treatment group were mailed 2 sets of 2% chlorhexidine gluconateeimpregnated cloths. These patients were instructed to shower with soap and water the evening before their operation and to wipe their entire operative extremity, including the axilla, shoulder, and ipsilateral chest and back, with a 2% chlorhexidine gluconateeimpregnated cloth 1 hour after showering. The morning of surgery, patients in the treatment group were instructed to avoid showering and to apply a second 2% chlorhexidine gluconateeimpregnated cloth in the same manner as the first within 2 hours of departing for the hospital. Patients assigned to the control group were instructed to shower with soap and water the morning of surgery.
Patients Upon arrival at the preoperative holding area, the patients completed a questionnaire that included age, ability to complete the preoperative cleansing protocol, the occurrence of adverse reactions to the chlorhexidine gluconate cloths, whether they were heavy smokers (>1.5 packs/d), had diabetes mellitus, were taking immunosuppressive medications, were taking antibiotics, or had shaved their axilla before surgery.
929
Bacterial sampling and culture analysis While patients were in the preoperative holding area, cutaneous swabs were taken for qualitative anaerobic and aerobic culture from the posterior shoulder (2 cm inferior and 1 cm medial to the posterolateral border of the acromion) and from the axilla. Next, a quantitative blood agar plate (Remel, Lenexa, KS, USA) was placed in contact with the posterior shoulder. The microbiology department at our institution analyzed the samples and was blinded to the treatment. The samples were maintained for 7 days to monitor for growth of Propionibacterium acnes based on a reported average incubation period of 5.1 days to isolate this organism.17 As a control for possible false-positive results from the microbiologic analysis, we sent 7 aerobic, 7 anaerobic, and 7 blood agar plates for analysis after exposing the swab or plate to room air.
Antibiotic prophylaxis Preoperative antibiotics of (1 gram of cefazolin if weight was <90 kg and 2 grams if weight was >90 kg, or 900 mg of clindamycin, if allergic to penicillin) were administered to all 100 patients within 1 hour of the skin incision. Patients undergoing shoulder arthroplasty received the same protocol, with the addition of 1 gram of vancomycin, which is the standard protocol for joint arthroplasty at our institution. An antibacterial-impregnated barrier (Ioban, 3M Healthcare, St. Paul, MN, USA) was used for all cases that involved the implantation of a prosthesis, as this is the standard practice of the surgeons involved with this study who perform shoulder arthroplasty. Intraoperatively, each shoulder was prepared with ChloraPrep (2% chlorhexidine gluconate and 70% isopropyl alcohol; Enturia, El Paso, TX, USA), as is the standard practice for each of the attending surgeons involved in the study. All cultures were obtained before preparation of the skin and placement of barrier drapes occurred.
Detection of clinical infection Patients were monitored prospectively for possible development of infection for a 2-month period after their operation. The attending surgeons who performed the postoperative clinical surveillance for infection were blinded to the treatment arm that their patients had been allocated to.
Statistical analysis An a priori sample size calculation of 45 patients per group had 80% power to detect at least a 30% difference in positive organisms between groups. This difference has been considered to be clinically significant, using a two-tailed test and a type I error rate of 5%.9 The actual sample size of 50 patients per group had 80% power to detect a 28% difference. All statistical comparisons between groups were on an intentto-treat basis. Clinical characteristics were compared between groups using the Wilcoxon rank sum test for age or the Fisher exact test for other dichotomous variables. Posterior and axilla qualitative measures were each compared between the treatment
930 Table I
M.R. Murray et al. Patient characteristics
Variable) Age, years Sex (M/F) Smoker (>1.5 PPD) Diabetes mellitus Immunosuppressive medications Taking antibiotics Shaved axilla Type of surgery Open Arthroscopic Compliance with protocol Side effects
Control
Chlorhexidine
(n ¼ 50)
(n ¼ 50)
52.0 16.7 25/25 (50% male) 1 (2) 4 (8) 0 (0) 0 (0) 12 (24)
49.0 16.2 36/14 (72% male) 1 (2) 4 (8) 1 (2) 1 (2) 8 (16)
8 42 50/50 (100) 0 (0)
6 44 45/50 (90) 12 (24)
P .14 .04y >.99 >.99 .99 .99 .45 .77
.056 .0002
PPD, packs per day. ) Data are expressed as number (%), except where noted. y Statistically significant (P < .05).
(2% chlorhexidine gluconateeimpregnated cloths) and control (standard soap-and-water shower) groups using the Fisher exact test. Quantitative counts in positive cases were compared between groups using the Wilcoxon rank sum test. All tests were 2-tailed. All statistical analyses were performed by an independent statistician using OnlineDoc 9.2 (SAS Institute Inc,Cary, NC, USA).
Results Patient characteristics are summarized in Table I. The study included 61 men and 39 women, and the patient ages ranged from 19 to 86 years. Men comprised 36 of 50 patients (72%) in the treatment group and 25 of 50 patients (50%) in the control group (P ¼ .04). The treatment group underwent 44 entirely arthroscopic surgeries and 6 open surgeries (6 primary total shoulder arthroplasties). The control group underwent 42 arthroscopic surgeries and 8 open surgeries (P ¼ .77 compared with control), comprising 6 primary total shoulder arthroplasties, 1 revision total shoulder arthroplasty, and 1 open Weaver-Dunn procedure. There were no acute trauma patients in this study. In the control group, there was 1 heavy smoker (>1.5 packs/d), 4 patients had diabetes mellitus, and 8 patients had shaved their axilla before surgery. In the treatment group, there was 1 heavy smoker (>1.5 packs/d), 4 patients had diabetes mellitus, 1 patient had taken an immunosuppressive medication (10 mg of prednisone daily), 1 patient had taken amoxicillin for an upper respiratory infection, and 6 patients reported shaving their axilla before surgery. No serious adverse effects occurred in any patients. However, a questionnaire revealed that 24% of patients in the treatment group reported mild itching or a feeling of dry skin after application of the 2% chlorhexidine gluconatee impregnated cloths. No surgical procedures were cancelled secondary to problems pertaining to the skin.
Of the 50 patients in the treatment group, 45 (90%) reported complete compliance with instructions for home application of the 2% chlorhexidine gluconatee impregnated cloth. Five patients reported incomplete compliance with the protocol: 4 patients were unable to elevate their arm sufficiently to apply the cloth to their axilla, and 1 patient showered in between applications of the 2% chlorhexidine gluconateeimpregnated cloths. The overall positive culture rate for all bacteria at both sites (combined posterior shoulder and axillary cultures) was 66% in the treatment group compared with 94% in the control group (P ¼ .0008). The positive culture rate for coagulase-negative Staphylococcus was 30% in the treatment group compared with 70% in the control group (P ¼ .0001). The positive culture rate for Corynebacterium was 8% in the treatment group compared with 28% in the control group (P ¼ .017). The positive culture rate for P acnes was 46% in the treatment group compared with 58% in the control group (P ¼ .32; Table II; Fig. 1). For the posterior shoulder site, the positive culture rate was 50% in the treatment group vs 74% in the control group (P ¼ .023). The positive culture rate for coagulasenegative Staphylococcus was 10% in the treatment group compared with 50% in the control group (P < .0001). The positive-culture rate for Corynebacterium was 0% in the treatment group compared with 12% in the control group (P ¼ .027). The positive culture rate for P acnes was 40% in both groups (Table III). For the axilla, the positive culture rate was 42% in the treatment group and 78% in the control group (P ¼ .0005). The positive culture rate for coagulase-negative Staphylococcus was 22% in the treatment group compared with 60% in the control group (P ¼ .0002). The positive culture rate for P acnes was 24% in the treatment group compared with 30% in the control group (P ¼ .65; Table III).
Use of 2% chlorhexidine cloth before shoulder surgery Table II
Rate of positive cultures from entire shoulder region (combined from axilla and posterior shoulder)
Organism
All organisms Coagulase-negative Staphylococcus Propionibacterium acnes Corynebacterium Gram-negative bacilli Micrococcus Peptostreptococcus Clostridium Staphylococcus aureus Lactobacillus Enterococcus Bifidobacterium Staphylococcus warneri b-Hemolytic Streptococcus Eubacterium
Control
Chlorhexidine
(n ¼ 50)
(n ¼ 50)
No. (%)
No. (%)
47 35 29 14 7 5 2 2 3 2 0 1 0 0 1
33 15 23 4 4 0 2 2 0 0 1 0 1 1 0
(94) (70) (58) (28) (14) (10) (4) (4) (6) (4) (0) (2) (0) (0) (2)
P
.0008) .0001) .32 .017) .52 .057 >.99 >.99 .24 .49 .99 .99 .99 .99 .99
(66) (30) (46) (8) (8) (0) (4) (4) (0) (0) (2) (0) (2) (2) (0)
Statistically significant (P < .05).
Quantitative bacterial cultures positive for bacterial growth were analyzed for the number of bacterial colonies/ cm2. Median values of colonies/cm2 were 0.11 in the treatment group and 0.35 in the control group for coagulase-negative Staphylococcus (P ¼ .002), 0.035 in the treatment group and 0.071 colonies/cm2 in the control group for gram-negative bacilli (P ¼ .017), 0.071 in the treatment group and 0.25 in the control group for Corynebacterium (P ¼ .73), and 0.035 in the treatment group and 0.32 in the control group for Micrococcus (P ¼ .019). P acnes did not grow at a sufficient level from the quantitative cultures to provide a comparison between the treatment and control groups (Table IV). To evaluate for possible false-positive culture rates, we exposed 7 qualitative anaerobic swabs, 7 qualitative aerobic swabs, and 7 contact blood agar quantitative plates to room air for approximately 20 seconds. These specimens were processed and analyzed in the same fashion as the other specimens. At the end of 7 days, none of the specimens displayed any bacterial growth.
Discussion Fortunately, deep infection is a relatively rare event after shoulder surgery, with reported rates of 0.006% to 3.4% after arthroscopy,2,3,12,18 0.27% to 1.9% after open rotator cuff repair,1,5-8,14 and 0% and 3.9 % after unconstrained shoulder arthroplasty.15,19 Patients who experience infection after shoulder surgery are often dissatisfied with their outcome and can experience significant morbidity if multiple procedures are required in addition to the index operation.6,8
% positive
)
931
100 90 80 70 60 50 40 30 20 10 0
Control
Treatment
Organism
Figure 1 Rate of positive qualitative cultures for overall shoulder area (posterior and axilla).
The present study is in agreement with other studies that have found coagulase-negative Staphylococcus and P acnes, to be the most commonly isolated organisms from the shoulder region.10,13 As far as we know, the current study is the first to use quantitative cultures around the shoulder after preparation of this region for surgery. We were able to demonstrate a 3-fold lower colony count for coagulase-negative Staphylococcus when chlorhexidine gluconateeimpregnated cloths were used compared with a standard shower with soap and water. Although we did not observe a significant reduction in P acnes, a trend toward lower positive culture rate of 46% was noted in the treatment group compared with 58% in the control group (P ¼ .32). There were 36 men in the treatment group vs 25 men in the control group (P ¼ .04), which may have influenced our results as men have higher rates of
932
M.R. Murray et al.
Table III
Rate of positive qualitative cultures from posterior shoulder site and axilla
Organism
Posterior, No. (%)
All organisms Coagulase-negative Staphylococcus Propionibacterium acnes Corynebacterium Micrococcus Gram-negative bacilli Peptostreptococcus Clostridium Staphylococcus aureus Enterococcus Bifidobacterium Lactobacillus Staphylococcus warneri b-Hemolytic Streptococcus Eubacterium
Axilla, No. (%)
Control
Chlorhexidine
(n ¼ 50)
(n ¼ 50)
P
37 (74) 25 (50)
25 (50) 5 (10)
.023) <.0001)
20 6 4 3 1 2 0 0 1 0 0 0 0
20 0 0 1 2 1 0 1 0 0 1 0 0
>.99 .027) .12 .62 .99 .99 NT .99 >.99 NT .99 NT NT
(40) (12) (8) (6) (2) (4) (0) (0) (2) (0) (0) (0) (0)
(40) (0) (0) (2) (4) (2) (0) (2) (0) (0) (2) (0) (0)
Control
Chlorhexidine
(n ¼ 50)
(n ¼ 50)
39 (78) 30 (60)
21 (42) 11 (22)
15 10 1 5 1 0 3 0 0 2 0 0 1
12 4 0 3 1 1 0 0 0 0 0 1 0
(30) (20) (2) (10) (2) (0) (6) (0) (0) (4) (0) (0) (2)
(24) (8) (0) (6) (2) (2) (0) (0) (0) (0) (0) (2) (0)
P .0005) .0002) .65 .15 .99 .72 >.99 .99 .24 NT NT .49 NT .99 .99
NT, no statistical test was done because all frequencies were 0. ) Statistically significant (P < .05).
Table IV
Median number of colony counts per cm2
Organism Coagulase-negative Staphylococcus Gram-negative bacilli Micrococcus Corynebacterium )
Control
Chlorhexidine
P
Count
No. Count
No.
0.35
49
0.11
20
.002)
0.071 0.32 0.25
18 20 25
0.035 0.035 0.071
5 3 3
.017) .019) .73
Statistically significant (P < .05).
colonization with P acnes than women.10 Because no infections occurred during the course of this study, we do not know whether reduction in bacterial loads will translate into lower infection rates after shoulder surgery. Several studies have found that chlorhexidine-based skin preparation solutions decrease positive culture rates13,15 and surgical site infections,4,9,13 but the role of chlorhexidine gluconateeimpregnated cloths has not been as rigorously evaluated. We previously reported that a chlorhexidine-based skin preparation solution is more efficacious than povidonebased products at eliminating bacteria from the shoulder.13 Popovich et al11 demonstrated that daily skin cleansing with 2% chlorhexidine gluconate cloths resulted in a significantly decreased rate of central venous catheter-associated bloodstream infections compared with daily washing with soap and water.11 The present study is the first study to evaluate the efficacy of 2% chlorhexidine gluconatee impregnated cloths before shoulder surgery.
Our study had several important limitations. First, we examined positive culture rates and did not directly examine infection rates. Because infection is relatively rare after shoulder surgery, a much larger patient population would be necessary to directly evaluate infection rates. Second, we did not obtain cultures after the skin had been prepared for surgery, thus we do not know if there is a synergistic effect of using 2% chlorhexidine gluconateeimpregnated washcloths along with intraoperative skin preparation with a chlorhexidine-based agent. Financial constraints precluded us from being able to take a second set of cultures after surgical skin preparation in the operating room. Third, the manufacturer of the 2% chlorhexidine gluconateeimpregnated cloths provided the funding for this study. This funding was used exclusively for microbiology expenses, and the manufacturer was not involved with study organization, data analysis, or writing of the manuscript.
Conclusion We were able to demonstrate a significant reduction in the overall bacterial load around the shoulder, including coagulase-negative Staphylococcus, a pathogen known to cause postoperative shoulder infections,1,8,14 when chlorhexidine cloths were used compared with a standard shower with soap and water. The potential benefit of chlorhexidine-impregnated cloths for skin preparation comes at a relatively low cost of approximately $3 per
Use of 2% chlorhexidine cloth before shoulder surgery package of two 2% chlorhexidine gluconateeimpregnated cloths, and its use appears relatively safe. Use of chlorhexidine-impregnated cloths before shoulder surgery may be a useful adjunct to other presently used infection prevention strategies.
Disclaimer External funding of this study was obtained from Sage Products Inc (Cary, IL, USA), the company that manufactures the 2% chlorhexidine gluconateeimpregnated cloths. This funding was used exclusively for microbiology expenses, and the company was not involved with the study design, analysis of the data, or writing of this manuscript. A grant of $32,000 was received from Sage Products Inc as a research grant to Northwestern University.
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