ORIGINAL ARTICLES Pediatric Dermatology Vol. 33 No. 2 136–141, 2016
Surgical Site Infection After Skin Excisions in Children: Is Field Sterility Sufficient? Laura C. Nuzzi, B.A., Arin K. Greene, M.D., M.M.Sc., John G. Meara, M.D., D.M.D., M.B.A., Amir Taghinia, M.D., M.P.H., and Brian I. Labow, M.D. Department of Plastic and Oral Surgery, Boston Children’s Hospital and Harvard Medical School, Boston, Massachusetts
Abstract: Skin excisions are common procedures in children. They may be performed in the clinic using field sterility or the operating room with strict sterile technique. We compared the effect of these locations and the use of antibiotics on the incidence of surgical site infection (SSI) after skin excisions. Patients ages 0–18 years presenting to our department for the excision of lesions from 2006 to 2010 with complete medical records were included in our study. Records were reviewed for demographic characteristics, presentation, perioperative conditions, and postoperative SSI and other wound complications. Analyses were performed to estimate the costs associated with sterility technique and perioperative antibiotic use. We identified 700 patients with a mean age of 9.1 years. Of 872 lesions excised, 0.3% resulted in SSI and 1.8% had other wound complications. The incidence of SSI did not vary according to sterility technique, antibiotic usage, surgeon, age, or lesion size, type, or location. The equipment costs to excise a lesion in the operating room were 200% greater than in the clinic. The incidence of SSI after excision of benign lesions in children did not differ between those performed using clinic field sterility and those using the standard aseptic sterile technique in the operating room. A considerable cost savings could be realized by adopting field sterility for simple excisions performed in the operating room and avoiding routine perioperative antibiotics in pediatric skin excisions.
The excision of skin lesions is one of the most common pediatric procedures (1,2). Depending on a number of factors such as age, patient cooperation, and surgeon comfort, these operations may be performed in the clinic setting using local anesthesia and field sterility or in the operating room under
general anesthesia. Few reports have compared the rate of surgical site infection (SSI) between these locations. With a reported incidence of SSI of 0.8%, perioperative antibiotics are not advised for excisions of nonulcerating skin lesions performed on healthy
Address correspondence to Brian I. Labow, M.D., Department of Plastic and Oral Surgery, Boston Children’s Hospital, 300 Longwood Avenue, Boston, MA 02115, or e-mail: [email protected]. DOI: 10.1111/pde.12523
136
© 2015 Wiley Periodicals, Inc.
Nuzzi et al: Field Sterility in Pediatric Skin Excisions
patients (3–5). Despite this, a recent study found that 48% of dermatologists use antibiotics for routine procedures (3). It has not been demonstrated that antibiotic prophylaxis significantly reduces infection rates in these procedures (3). We report our historic practice patterns with respect to antibiotic use and the incidence of SSI and other complications in the office and main operating room setting. Cost-savings analyses have also been performed, and treatment recommendations are made to improve quality of care.
137
antibiotic use, operative setting, surgeon, lesion type and location, and sex. The effect of antibiotic use, surgeon, lesion type and size, and patient age as potential confounders of the association between operative setting and SSI status was explored using a logistic regression model. Cost-savings analyses were used to calculate and compare material costs of excisions performed in each location.
RESULTS Clinical Features
MATERIALS AND METHODS Approval from our institution’s Committee on Clinical Investigation was obtained with a waiver of informed consent. We retrospectively identified the medical records of patients who underwent skin excisions for benign lesions at our institution from 2006 through 2010 using Current Procedural Terminology codes 11400–11450. Excised lesions included congenital melanocytic nevi, nevi sebaceous, hypertrophic scars, and other benign pigmented lesions. All patients were ages 0 to 18 years and were treated by a pediatric plastic surgeon. Medical records were reviewed for patient demographic characteristics, lesion type, procedure setting, antibiotic usage, postoperative SSI, and other wound complications. Only patients with complete medical records were included. SSI was defined using Centers for Disease Control and Prevention criteria as any infection of the surgical site occurring within the first 30 days after excision (5). Other wound complications were defined as any unexpected negative wound outcome occurring within the first postoperative month. All procedures in the operating room were performed using the standard aseptic sterile technique, and clinic procedures were performed under field sterility (6), which consisted of a povidone–iodine skin preparation, sterile towels around the lesion, and a sterile instrument tray. The surgeon and assistant wore sterile gloves, but no surgical scrub was performed. Statistical analyses were conducted using SAS 9.2 (SAS Institute, Cary, NC) and SPSS version 21.0 (IBM, Armonk, NY). The mean age and median lesion size (diameter at the widest point in centimeters) were calculated and differences were compared according to operative setting and antibiotic use using independent-sample t-tests and Mann-Whitney U tests, respectively. Chi-square and Fisher exact tests were used to compare differences in the proportion of SSI, antibiotic use, and operative setting according to the following variables when appropriate: SSI status,
Seven hundred patients who underwent 872 excisions were identified. Mean patient age standard deviation was 9.1 5.2 years, and 53.6% were female (n = 375) (Table 1). Most skin excisions were for pigmented lesions (768 [88.1%]; Fig. 1). Keloids and hypertrophic scars (65 [7.5%]) and nevi sebaceous (39 [4.5%]) were also represented. The most common anatomic sites were the face (388 [44.5%]) and trunk (218 [25.0%]), followed by the scalp and lower and upper extremities (Fig. 2). The lesion size was skewed right, with a median size of 2.00 cm (interquartile range 0–4 cm). Infection and Wound Complications Three (0.3%) excisions resulted in SSI and were at least partially dehisced. All patients with SSIs required oral antibiotics and two required drainage. All infections resulted from the excision of pigmented lesions, two located on the trunk and the third on the scalp. The ages of patients with infection ranged from 5.1 to 12.7 years, and infected lesions ranged in size from 2.5 to 3.5 cm. Sixteen excisions (1.8%) had other wound complications; partial wound dehiscence was the most common (12 [1.4%]), followed by seroma, prolonged erythema, site alopecia, and local allergic reactions (1 [0.1%] each) (Table 2). SSIs did not vary according to operative setting or antibiotic use (Table 3). Similarly, no difference in SSI was seen with surgeon; lesion type, size, or location; or patient age or sex.
TABLE 1. Patient Demographic Characteristics (N = 700) Characteristic
Value
Age, mean standard deviation Sex, n (%) Female Male
9.1 5.2 375 (53.6) 325 (46.4)
140 Pediatric Dermatology Vol. 33 No. 2 March/April 2016
A
B
Figure 3. Disposable waste generated from one skin lesion excision: (A) clinic setting using field sterility, (B) operating room using aseptic sterile technique.
dermatologic procedures (3–5). In addition to cost savings, the benefits of limiting unnecessary routine antibiotic administration in terms of diminished drug resistance and Clostridium difficile colitis are well described (3). The high frequency of antibiotic use in our study, as well as in other reports, suggests that additional education is required. Considerable savings can be achieved through incremental cost reductions in high-volume procedures. Skin excisions are a prime example, with 14 million performed on children and adults in the United States annually (7). Although it seems obvious that the cost of excising a skin lesion in the operating room will be more expensive than a comparable excision in the clinic, less clear are the potential savings in removing the traditional items inherent to any procedure performed in the operating room. In the current study, unnecessary equipment led to a roughly 200% greater cost for every excision performed in the operating room than in the clinic. Additional savings can also be achieved by reducing unnecessary antibiotic usage. Our department could save roughly $57,000 annually simply by adopting the same practices used in our clinic when a child undergoes the same procedure in the operating room. Extending this approach to similar procedures such as the excision of a simple polydactyly or accessory ear tags would further augment savings. Additional savings could be expected in the reduction of time needed to set up the operating room for these cases, room turnover times, and especially waste disposal. Hospitals are the second
largest contributor of waste in the United States, generating more than 4 billion pounds annually. It is estimated that the operating room generates 70% of this waste (8). We recommend that for the excision of clean lesions for which a general anesthetic is required, a greener field sterility approach be brought to the operating room to reduce waste and cost while delivering the same standard of care. Study limitations must be addressed. Approximately 20% of cases originally identified were excluded from analyses because of missing data. Given the rarity of SSI, our sample size may lack adequate power to appreciate small differences in SSI incidence. Our findings may not be generalizable because procedures were performed in a single department at a large, urban tertiary care facility. A large, prospective, multicenter clinical trial could be implemented to minimize confounding variables and missing data. In addition, missing data prevented cost analyses from including waste disposal, staffing costs, and provider and staff time. CONCLUSIONS Benign skin lesion excision is a common procedure in children. None of the variables examined in our study had a statistical effect on SSI, including size or type of lesion or anatomic location. Neither antibiotic usage nor strict operating room aseptic technique affected the SSI rate. These findings could serve to reduce the cost of care delivery and improve operating room efficiency.
Nuzzi et al: Field Sterility in Pediatric Skin Excisions
TABLE 3. Perioperative Conditions No complication (n = 869) Condition Perioperative antibiotics Yes No Operative setting Operating room Clinic
Infection (n = 3)
n (%)
p-Value*
174 (20.0) 695 (80.0)
1 (33.3) 2 (66.7)
0.49
592 (68.1) 277 (31.9)
2 (66.7) 1 (33.3)
0.99
*Fisher exact test.
(p < 0.05). Patients receiving antibiotics were also younger (p < 0.001). When accounting for differences in antibiotic usage, surgeon, lesion type and size, and patient age, there was still no difference found between the proportion of SSIs after excisions performed in the clinic and the proportion performed in the operating room (p = 0.27). Cost Savings We calculated the material costs to excise one lesion in our main operating room to be 193% more expensive than to excise the same lesion in our clinic. A single procedure performed in the operating room generated considerably more waste than in the clinic (Fig. 3). Using these cost estimates, we approximate a savings of roughly $57,000 annually in our department alone if field sterility is used, regardless of operative location, and antibiotic overuse is eliminated. DISCUSSION The excision of skin lesions is one of the most common pediatric procedures in the United States (1). This short, well-tolerated procedure can be accomplished in the clinic, although for anxious or uncooperative patients or in cases involving larger lesions in difficult areas, general anesthesia is required. Procedures performed in the operating room typically adhere to a strict code of aseptic sterile technique, even though the additional equipment and disposable resources may not be medically necessary. To address this question, the present study is the first to compare the incidence of SSI in children undergoing clean excisions in these two settings. The additional measures of formal aseptic technique with or without antibiotics did not decrease SSI or wound complication rates. Cost savings can be achieved by adopting clinic field sterility and limiting materials in the
139
management of these types of lesions, regardless of setting. In our sample of 872 children, 68% of cases were performed in the operating room, typically necessitated by the need for general anesthesia. No standard guidelines exist as to the age at which local anesthesia is appropriate. As such, patient, parent, and provider factors all play a part in determining the setting for excision. As expected, patients treated in the operating room were significantly younger than those treated in the clinic setting (7.3 vs 9.5 yrs). Lesions excised in the operating room were larger and more often on the face than those excised in the clinic. Although patient, parent, and provider education may decrease the need for use of the operating room, we do not believe that a single set of criteria can be applied to all patients. The overall incidence of SSI in our study was low (0.03%) and compares well with similar studies (4). Fewer than 2% of all excisions had postoperative wound complications other than infection. The incidence of infection did not vary according to setting, even when accounting for differences in lesion size, type, patient age, and surgeon. Similar findings were reported from a randomized clinical trial comparing the incidence of infection after carpal tunnel releases performed using field sterility and operating room sterility (6). As a result, providers, parents, and hospital administrators can be reassured that simple skin excisions performed in the clinic are just as safe from an infection standpoint as those performed in the operating room. By extension, field sterility would appear to be sufficient to limit SSI for these types of procedures. Historically, the administration of perioperative antibiotics has been used to limit SSI after surgery. Well-established guidelines for administration now exist, and recommendations have been made to avoid antibiotic use for clean, noncontaminated skin lesions (4,5). Despite this, reports have documented persistent usage in roughly 50% of dermatologic procedures (3). Surgeons in our study were free to order antibiotics as they deemed necessary, with a usage rate of roughly 30% for operating room cases. Antibiotic use varied according to age and lesion location. Because only patients who underwent excisions in the operating room received antibiotics, these patients were significantly younger. These lesions were more likely to be near areas containing nonskin flora, such as on the face near the mouth. As expected, the incidence of infection in our study did not vary with antibiotic administration, which echoes the results of prior studies, arguing for limited antibiotic use in clean
140 Pediatric Dermatology Vol. 33 No. 2 March/April 2016
A
B
Figure 3. Disposable waste generated from one skin lesion excision: (A) clinic setting using field sterility, (B) operating room using aseptic sterile technique.
dermatologic procedures (3–5). In addition to cost savings, the benefits of limiting unnecessary routine antibiotic administration in terms of diminished drug resistance and Clostridium difficile colitis are well described (3). The high frequency of antibiotic use in our study, as well as in other reports, suggests that additional education is required. Considerable savings can be achieved through incremental cost reductions in high-volume procedures. Skin excisions are a prime example, with 14 million performed on children and adults in the United States annually (7). Although it seems obvious that the cost of excising a skin lesion in the operating room will be more expensive than a comparable excision in the clinic, less clear are the potential savings in removing the traditional items inherent to any procedure performed in the operating room. In the current study, unnecessary equipment led to a roughly 200% greater cost for every excision performed in the operating room than in the clinic. Additional savings can also be achieved by reducing unnecessary antibiotic usage. Our department could save roughly $57,000 annually simply by adopting the same practices used in our clinic when a child undergoes the same procedure in the operating room. Extending this approach to similar procedures such as the excision of a simple polydactyly or accessory ear tags would further augment savings. Additional savings could be expected in the reduction of time needed to set up the operating room for these cases, room turnover times, and especially waste disposal. Hospitals are the second
largest contributor of waste in the United States, generating more than 4 billion pounds annually. It is estimated that the operating room generates 70% of this waste (8). We recommend that for the excision of clean lesions for which a general anesthetic is required, a greener field sterility approach be brought to the operating room to reduce waste and cost while delivering the same standard of care. Study limitations must be addressed. Approximately 20% of cases originally identified were excluded from analyses because of missing data. Given the rarity of SSI, our sample size may lack adequate power to appreciate small differences in SSI incidence. Our findings may not be generalizable because procedures were performed in a single department at a large, urban tertiary care facility. A large, prospective, multicenter clinical trial could be implemented to minimize confounding variables and missing data. In addition, missing data prevented cost analyses from including waste disposal, staffing costs, and provider and staff time. CONCLUSIONS Benign skin lesion excision is a common procedure in children. None of the variables examined in our study had a statistical effect on SSI, including size or type of lesion or anatomic location. Neither antibiotic usage nor strict operating room aseptic technique affected the SSI rate. These findings could serve to reduce the cost of care delivery and improve operating room efficiency.
Nuzzi et al: Field Sterility in Pediatric Skin Excisions
ACKNOWLEDGMENTS The authors thank Susan Flath-Sporn, M.P.H., and Ronald Heald, M.B.A., for their contribution to cost analyses. REFERENCES 1. Berg P, Lindelof B. Congenital nevocytic nevi: follow-up of a Swedish birth register sample regarding etiologic factors, discomfort, and removal rate. Pediatr Dermatol 2002;19:293–297. 2. Stanganelli I, Ascierto P, Bono R et al. Management of small and intermediate congenital nevi: a nationwide survey in Italy. Dermatology 2013;226(Suppl 1):7–12. 3. Bae-Harboe YS, Liang CA. Perioperative antibiotic use of dermatologic surgeons in 2012. Dermatol Surg 2013;39:1592–1601.
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4. Shehab N, Patel PR, Srinivasan A et al. Emergency department visits for antibiotic-associated adverse events. Clin Infect Dis 2008;47:735–743. 5. Rossi AM, Mariwalla K. Prophylactic and empiric use of antibiotics in dermatologic surgery: a review of the literature and practical considerations. Dermatol Surg 2012;38:1898–1921. 6. Leblanc MR, Lalonde DH, Thoma A et al. Is main operating room sterility really necessary in carpal tunnel surgery? A multicenter prospective study of minor procedure room field sterility surgery. Hand (N Y) 2011;6:60–63. 7. Levender MM, Davis SA, Kwatra SG et al. Use of topical antibiotics as prophylaxis in clean dermatologic procedures. J Am Acad Dermatol 2012;66:445–451. 8. Kwakye G, Brat GA, Makary MA. Green surgical practices for health care. Arch Surg 2011;146:131– 136.
Surgical Site Infection After Skin Excisions in Children: Is Field Sterility Sufficient? Laura C. Nuzzi, B.A., Arin K. Greene, M.D., M.M.Sc., John G. Meara, M.D., D.M.D., M.B.A., Amir Taghinia, M.D., M.P.H., and Brian I. Labow, M.D. Department of Plastic and Oral Surgery, Boston Children’s Hospital and Harvard Medical School, Boston, Massachusetts
Abstract: Skin excisions are common procedures in children. They may be performed in the clinic using field sterility or the operating room with strict sterile technique. We compared the effect of these locations and the use of antibiotics on the incidence of surgical site infection (SSI) after skin excisions. Patients ages 0–18 years presenting to our department for the excision of lesions from 2006 to 2010 with complete medical records were included in our study. Records were reviewed for demographic characteristics, presentation, perioperative conditions, and postoperative SSI and other wound complications. Analyses were performed to estimate the costs associated with sterility technique and perioperative antibiotic use. We identified 700 patients with a mean age of 9.1 years. Of 872 lesions excised, 0.3% resulted in SSI and 1.8% had other wound complications. The incidence of SSI did not vary according to sterility technique, antibiotic usage, surgeon, age, or lesion size, type, or location. The equipment costs to excise a lesion in the operating room were 200% greater than in the clinic. The incidence of SSI after excision of benign lesions in children did not differ between those performed using clinic field sterility and those using the standard aseptic sterile technique in the operating room. A considerable cost savings could be realized by adopting field sterility for simple excisions performed in the operating room and avoiding routine perioperative antibiotics in pediatric skin excisions.
The excision of skin lesions is one of the most common pediatric procedures (1,2). Depending on a number of factors such as age, patient cooperation, and surgeon comfort, these operations may be performed in the clinic setting using local anesthesia and field sterility or in the operating room under
general anesthesia. Few reports have compared the rate of surgical site infection (SSI) between these locations. With a reported incidence of SSI of 0.8%, perioperative antibiotics are not advised for excisions of nonulcerating skin lesions performed on healthy
Address correspondence to Brian I. Labow, M.D., Department of Plastic and Oral Surgery, Boston Children’s Hospital, 300 Longwood Avenue, Boston, MA 02115, or e-mail: [email protected]. DOI: 10.1111/pde.12523
136
© 2015 Wiley Periodicals, Inc.
Nuzzi et al: Field Sterility in Pediatric Skin Excisions
patients (3–5). Despite this, a recent study found that 48% of dermatologists use antibiotics for routine procedures (3). It has not been demonstrated that antibiotic prophylaxis significantly reduces infection rates in these procedures (3). We report our historic practice patterns with respect to antibiotic use and the incidence of SSI and other complications in the office and main operating room setting. Cost-savings analyses have also been performed, and treatment recommendations are made to improve quality of care.
137
antibiotic use, operative setting, surgeon, lesion type and location, and sex. The effect of antibiotic use, surgeon, lesion type and size, and patient age as potential confounders of the association between operative setting and SSI status was explored using a logistic regression model. Cost-savings analyses were used to calculate and compare material costs of excisions performed in each location.
RESULTS Clinical Features
MATERIALS AND METHODS Approval from our institution’s Committee on Clinical Investigation was obtained with a waiver of informed consent. We retrospectively identified the medical records of patients who underwent skin excisions for benign lesions at our institution from 2006 through 2010 using Current Procedural Terminology codes 11400–11450. Excised lesions included congenital melanocytic nevi, nevi sebaceous, hypertrophic scars, and other benign pigmented lesions. All patients were ages 0 to 18 years and were treated by a pediatric plastic surgeon. Medical records were reviewed for patient demographic characteristics, lesion type, procedure setting, antibiotic usage, postoperative SSI, and other wound complications. Only patients with complete medical records were included. SSI was defined using Centers for Disease Control and Prevention criteria as any infection of the surgical site occurring within the first 30 days after excision (5). Other wound complications were defined as any unexpected negative wound outcome occurring within the first postoperative month. All procedures in the operating room were performed using the standard aseptic sterile technique, and clinic procedures were performed under field sterility (6), which consisted of a povidone–iodine skin preparation, sterile towels around the lesion, and a sterile instrument tray. The surgeon and assistant wore sterile gloves, but no surgical scrub was performed. Statistical analyses were conducted using SAS 9.2 (SAS Institute, Cary, NC) and SPSS version 21.0 (IBM, Armonk, NY). The mean age and median lesion size (diameter at the widest point in centimeters) were calculated and differences were compared according to operative setting and antibiotic use using independent-sample t-tests and Mann-Whitney U tests, respectively. Chi-square and Fisher exact tests were used to compare differences in the proportion of SSI, antibiotic use, and operative setting according to the following variables when appropriate: SSI status,
Seven hundred patients who underwent 872 excisions were identified. Mean patient age standard deviation was 9.1 5.2 years, and 53.6% were female (n = 375) (Table 1). Most skin excisions were for pigmented lesions (768 [88.1%]; Fig. 1). Keloids and hypertrophic scars (65 [7.5%]) and nevi sebaceous (39 [4.5%]) were also represented. The most common anatomic sites were the face (388 [44.5%]) and trunk (218 [25.0%]), followed by the scalp and lower and upper extremities (Fig. 2). The lesion size was skewed right, with a median size of 2.00 cm (interquartile range 0–4 cm). Infection and Wound Complications Three (0.3%) excisions resulted in SSI and were at least partially dehisced. All patients with SSIs required oral antibiotics and two required drainage. All infections resulted from the excision of pigmented lesions, two located on the trunk and the third on the scalp. The ages of patients with infection ranged from 5.1 to 12.7 years, and infected lesions ranged in size from 2.5 to 3.5 cm. Sixteen excisions (1.8%) had other wound complications; partial wound dehiscence was the most common (12 [1.4%]), followed by seroma, prolonged erythema, site alopecia, and local allergic reactions (1 [0.1%] each) (Table 2). SSIs did not vary according to operative setting or antibiotic use (Table 3). Similarly, no difference in SSI was seen with surgeon; lesion type, size, or location; or patient age or sex.
TABLE 1. Patient Demographic Characteristics (N = 700) Characteristic
Value
Age, mean standard deviation Sex, n (%) Female Male
9.1 5.2 375 (53.6) 325 (46.4)
140 Pediatric Dermatology Vol. 33 No. 2 March/April 2016
A
B
Figure 3. Disposable waste generated from one skin lesion excision: (A) clinic setting using field sterility, (B) operating room using aseptic sterile technique.
dermatologic procedures (3–5). In addition to cost savings, the benefits of limiting unnecessary routine antibiotic administration in terms of diminished drug resistance and Clostridium difficile colitis are well described (3). The high frequency of antibiotic use in our study, as well as in other reports, suggests that additional education is required. Considerable savings can be achieved through incremental cost reductions in high-volume procedures. Skin excisions are a prime example, with 14 million performed on children and adults in the United States annually (7). Although it seems obvious that the cost of excising a skin lesion in the operating room will be more expensive than a comparable excision in the clinic, less clear are the potential savings in removing the traditional items inherent to any procedure performed in the operating room. In the current study, unnecessary equipment led to a roughly 200% greater cost for every excision performed in the operating room than in the clinic. Additional savings can also be achieved by reducing unnecessary antibiotic usage. Our department could save roughly $57,000 annually simply by adopting the same practices used in our clinic when a child undergoes the same procedure in the operating room. Extending this approach to similar procedures such as the excision of a simple polydactyly or accessory ear tags would further augment savings. Additional savings could be expected in the reduction of time needed to set up the operating room for these cases, room turnover times, and especially waste disposal. Hospitals are the second
largest contributor of waste in the United States, generating more than 4 billion pounds annually. It is estimated that the operating room generates 70% of this waste (8). We recommend that for the excision of clean lesions for which a general anesthetic is required, a greener field sterility approach be brought to the operating room to reduce waste and cost while delivering the same standard of care. Study limitations must be addressed. Approximately 20% of cases originally identified were excluded from analyses because of missing data. Given the rarity of SSI, our sample size may lack adequate power to appreciate small differences in SSI incidence. Our findings may not be generalizable because procedures were performed in a single department at a large, urban tertiary care facility. A large, prospective, multicenter clinical trial could be implemented to minimize confounding variables and missing data. In addition, missing data prevented cost analyses from including waste disposal, staffing costs, and provider and staff time. CONCLUSIONS Benign skin lesion excision is a common procedure in children. None of the variables examined in our study had a statistical effect on SSI, including size or type of lesion or anatomic location. Neither antibiotic usage nor strict operating room aseptic technique affected the SSI rate. These findings could serve to reduce the cost of care delivery and improve operating room efficiency.
Nuzzi et al: Field Sterility in Pediatric Skin Excisions
TABLE 3. Perioperative Conditions No complication (n = 869) Condition Perioperative antibiotics Yes No Operative setting Operating room Clinic
Infection (n = 3)
n (%)
p-Value*
174 (20.0) 695 (80.0)
1 (33.3) 2 (66.7)
0.49
592 (68.1) 277 (31.9)
2 (66.7) 1 (33.3)
0.99
*Fisher exact test.
(p < 0.05). Patients receiving antibiotics were also younger (p < 0.001). When accounting for differences in antibiotic usage, surgeon, lesion type and size, and patient age, there was still no difference found between the proportion of SSIs after excisions performed in the clinic and the proportion performed in the operating room (p = 0.27). Cost Savings We calculated the material costs to excise one lesion in our main operating room to be 193% more expensive than to excise the same lesion in our clinic. A single procedure performed in the operating room generated considerably more waste than in the clinic (Fig. 3). Using these cost estimates, we approximate a savings of roughly $57,000 annually in our department alone if field sterility is used, regardless of operative location, and antibiotic overuse is eliminated. DISCUSSION The excision of skin lesions is one of the most common pediatric procedures in the United States (1). This short, well-tolerated procedure can be accomplished in the clinic, although for anxious or uncooperative patients or in cases involving larger lesions in difficult areas, general anesthesia is required. Procedures performed in the operating room typically adhere to a strict code of aseptic sterile technique, even though the additional equipment and disposable resources may not be medically necessary. To address this question, the present study is the first to compare the incidence of SSI in children undergoing clean excisions in these two settings. The additional measures of formal aseptic technique with or without antibiotics did not decrease SSI or wound complication rates. Cost savings can be achieved by adopting clinic field sterility and limiting materials in the
139
management of these types of lesions, regardless of setting. In our sample of 872 children, 68% of cases were performed in the operating room, typically necessitated by the need for general anesthesia. No standard guidelines exist as to the age at which local anesthesia is appropriate. As such, patient, parent, and provider factors all play a part in determining the setting for excision. As expected, patients treated in the operating room were significantly younger than those treated in the clinic setting (7.3 vs 9.5 yrs). Lesions excised in the operating room were larger and more often on the face than those excised in the clinic. Although patient, parent, and provider education may decrease the need for use of the operating room, we do not believe that a single set of criteria can be applied to all patients. The overall incidence of SSI in our study was low (0.03%) and compares well with similar studies (4). Fewer than 2% of all excisions had postoperative wound complications other than infection. The incidence of infection did not vary according to setting, even when accounting for differences in lesion size, type, patient age, and surgeon. Similar findings were reported from a randomized clinical trial comparing the incidence of infection after carpal tunnel releases performed using field sterility and operating room sterility (6). As a result, providers, parents, and hospital administrators can be reassured that simple skin excisions performed in the clinic are just as safe from an infection standpoint as those performed in the operating room. By extension, field sterility would appear to be sufficient to limit SSI for these types of procedures. Historically, the administration of perioperative antibiotics has been used to limit SSI after surgery. Well-established guidelines for administration now exist, and recommendations have been made to avoid antibiotic use for clean, noncontaminated skin lesions (4,5). Despite this, reports have documented persistent usage in roughly 50% of dermatologic procedures (3). Surgeons in our study were free to order antibiotics as they deemed necessary, with a usage rate of roughly 30% for operating room cases. Antibiotic use varied according to age and lesion location. Because only patients who underwent excisions in the operating room received antibiotics, these patients were significantly younger. These lesions were more likely to be near areas containing nonskin flora, such as on the face near the mouth. As expected, the incidence of infection in our study did not vary with antibiotic administration, which echoes the results of prior studies, arguing for limited antibiotic use in clean
140 Pediatric Dermatology Vol. 33 No. 2 March/April 2016
A
B
Figure 3. Disposable waste generated from one skin lesion excision: (A) clinic setting using field sterility, (B) operating room using aseptic sterile technique.
dermatologic procedures (3–5). In addition to cost savings, the benefits of limiting unnecessary routine antibiotic administration in terms of diminished drug resistance and Clostridium difficile colitis are well described (3). The high frequency of antibiotic use in our study, as well as in other reports, suggests that additional education is required. Considerable savings can be achieved through incremental cost reductions in high-volume procedures. Skin excisions are a prime example, with 14 million performed on children and adults in the United States annually (7). Although it seems obvious that the cost of excising a skin lesion in the operating room will be more expensive than a comparable excision in the clinic, less clear are the potential savings in removing the traditional items inherent to any procedure performed in the operating room. In the current study, unnecessary equipment led to a roughly 200% greater cost for every excision performed in the operating room than in the clinic. Additional savings can also be achieved by reducing unnecessary antibiotic usage. Our department could save roughly $57,000 annually simply by adopting the same practices used in our clinic when a child undergoes the same procedure in the operating room. Extending this approach to similar procedures such as the excision of a simple polydactyly or accessory ear tags would further augment savings. Additional savings could be expected in the reduction of time needed to set up the operating room for these cases, room turnover times, and especially waste disposal. Hospitals are the second
largest contributor of waste in the United States, generating more than 4 billion pounds annually. It is estimated that the operating room generates 70% of this waste (8). We recommend that for the excision of clean lesions for which a general anesthetic is required, a greener field sterility approach be brought to the operating room to reduce waste and cost while delivering the same standard of care. Study limitations must be addressed. Approximately 20% of cases originally identified were excluded from analyses because of missing data. Given the rarity of SSI, our sample size may lack adequate power to appreciate small differences in SSI incidence. Our findings may not be generalizable because procedures were performed in a single department at a large, urban tertiary care facility. A large, prospective, multicenter clinical trial could be implemented to minimize confounding variables and missing data. In addition, missing data prevented cost analyses from including waste disposal, staffing costs, and provider and staff time. CONCLUSIONS Benign skin lesion excision is a common procedure in children. None of the variables examined in our study had a statistical effect on SSI, including size or type of lesion or anatomic location. Neither antibiotic usage nor strict operating room aseptic technique affected the SSI rate. These findings could serve to reduce the cost of care delivery and improve operating room efficiency.
Nuzzi et al: Field Sterility in Pediatric Skin Excisions
ACKNOWLEDGMENTS The authors thank Susan Flath-Sporn, M.P.H., and Ronald Heald, M.B.A., for their contribution to cost analyses. REFERENCES 1. Berg P, Lindelof B. Congenital nevocytic nevi: follow-up of a Swedish birth register sample regarding etiologic factors, discomfort, and removal rate. Pediatr Dermatol 2002;19:293–297. 2. Stanganelli I, Ascierto P, Bono R et al. Management of small and intermediate congenital nevi: a nationwide survey in Italy. Dermatology 2013;226(Suppl 1):7–12. 3. Bae-Harboe YS, Liang CA. Perioperative antibiotic use of dermatologic surgeons in 2012. Dermatol Surg 2013;39:1592–1601.
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