Wound classification in pediatric surgical procedures: Measured and found wanting

    Wound Classification in Pediatric Surgical Procedures: Measured and Found Wanting Tolulope A. Oyetunji, Dani O. Gonzalez, Katherine W. Gonzalez, Benedict C. Nwomeh, Shawn D. St. Peter PII: DOI: Reference:

S0022-3468(16)00158-5 doi: 10.1016/j.jpedsurg.2016.02.070 YJPSU 57610

To appear in:

Journal of Pediatric Surgery

Received date: Accepted date:

22 February 2016 26 February 2016

Please cite this article as: Oyetunji Tolulope A., Gonzalez Dani O., Gonzalez Katherine W., Nwomeh Benedict C., St. Peter Shawn D., Wound Classification in Pediatric Surgical Procedures: Measured and Found Wanting, Journal of Pediatric Surgery (2016), doi: 10.1016/j.jpedsurg.2016.02.070

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ACCEPTED MANUSCRIPT Wound Classification in Pediatric Surgical Procedures: Measured and Found Wanting Authors:

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Tolulope A. Oyetunji MD MPHa, Dani O. Gonzalez, MDb, Katherine W. Gonzalez MD a, Benedict C. Nwomeh, MD MPHb, Shawn D. St. Peter, MDa

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a. Department of Pediatric Surgery, Children's Mercy Hospitals and Clinics, 2401 Gillham Road, Kansas City, MO 64108, USA b. Department of Surgery, Nationwide Children’s Hospital, 700 Children’s Drive, Columbus, OH 43205, USA

Corresponding Author:

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Tolulope A. Oyetunji, MD MPH Department of Surgery Children’s Mercy Hospitals and Clinics 2401 Gilliam Road Kansas City, MO 64108 Telephone: (816) 983 6466 E-Mail: [email protected]

ACCEPTED MANUSCRIPT Abstract Purpose: Surgical wound classification has emerged as a measure of surgical quality of

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care, but scant data exist in the era of minimally invasive procedures, especially in

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children. The aim of this study is to examine the surgical site infection (SSI) rate by

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wound classification during common pediatric surgical procedures.

Methods: A retrospective analysis of the 2013 Pediatric was performed. National

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Surgical Quality Improvement Program (Peds-NSQIP) dataset was conducted. Patients undergoing pyloromyotomy, cholecystectomy, ostomy reversal, and appendectomy

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were included. Wound classification, SSI rate, re-operation, and re-admission were analyzed.

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Results: A total of 10,424 records were included. Pyloromyotomy, a clean case, had a 0.7% SSI rate, while ostomy reversal, a clean contaminated case, had an SSI in 6.9% of

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cases. Appendectomy for non-perforated acute appendicitis and laparoscopic cholecystectomy for cholecystitis, both contaminated cases, had SSI rates of 2.1% and

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<1%, respectively. Appendectomy for perforated appendicitis, a dirty procedure, had a 9.1 % SSI rate, below the expected >40% for dirty cases. Re-operations and re-

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admission rates ranged from <1 to 9% and increased with case complexity.

Conclusion: Current wound classifications systems do not reflect surgical risk in children and remain questionable tools for benchmarking surgical care in children. Role of re-admissions and re-operations as quality of care indices need further investigation.

Keywords: Surgical Site infection, wound classification

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Abbreviations

AORN- Association of periOperating Registered Nurses

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SSI- Surgical Site Infection

ACS- American College of Surgeons

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APSA- American Pediatric Surgical Association

NPA- Non Perforated Appendicitis

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PA- Perforated Appendicitis

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BD –Biliary Dyskinesia

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NSQIP- National Surgical Quality Improvement Program

ACCEPTED MANUSCRIPT Introduction Surgical site infection (SSI) is an important source of morbidity that has become a

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centerpiece for quality assurance programs in the operating room. In 2011, an estimated 157,500 SSIs occurred in the United States. [1] The impact of an SSI event has

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been estimated from $10,000 to $25,000 in hospital costs. [2-4] Therefore, current

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efforts are being directed at SSI prevention and mitigation of its impact.

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A wound classification schema stratifies surgical wounds into 4 classes (Class I –clean, Class II- clean-contaminated, Class III –contaminated and Class IV – dirty). [5, 6] The goal

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of this classification is to better predict wounds that have a higher risk of developing SSI and also potentially increase vigilance among the health care team. The Association of

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periOperating Registered Nurses (AORN) has therefore created an algorithm that is

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utilized in the operating room to stratify surgical wounds into these classes. [7]

Unfortunately, the literature is replete with data showing inconsistent and inaccurate classification of wounds intra-operatively. [8, 9] Likewise, the previously cited rate of SSI for each wound class has been shown to be much lower among adults utilizing data from the National Surgical Quality Improvement Program (NSQIP). [10] No data exists as to the true impact and role of the classification in children. Moreso, the impact of minimally invasive surgery on the incidence of SSI has not been adequately studied.

ACCEPTED MANUSCRIPT As the healthcare landscape shifts to quality-based care, hospital benchmarking on select measures is on the rise. The rate of SSI in post-operative patients is one of the

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potential benchmarks upon which hospital performance will be evaluated. Some authors critique this system, citing variability across institutions with respect to the

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methodology of wound classification practices. [8] Whether this quality indicator is valid in children has not been studied. Its impact on overall morbidity, mortality, or cost

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of health care in this population has also not been studied.

The aim of this study is to examine and compare the rate of SSI by current wound

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classification systems during common pediatric surgical procedures. This study also evaluated the rate of re-operation and re-admission associated with wound class in

Methods

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order to assess more appropriate quality-of-care measures to benchmark hospitals.

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A retrospective analysis of the 2013 Pediatric- National Surgical Quality Improvement Program (Peds-NSQIP) dataset was conducted. The Peds-NSQIP was developed by the American College of Surgeons (ACS) in collaboration with the American Pediatric Surgical Association (APSA) with a focus on creating highly reliable data that can be utilized to investigate surgical outcomes in children. Multiple data points are collected in children 18 years or younger, with additional data points in neonates. Patient outcomes are reported over a 30-day follow up period ( https://www.facs.org/qualityprograms/pediatric/overview). In the 2013 version, 147 variables, including preoperative risk factors, intra-operative variables and post-operative outcomes were

ACCEPTED MANUSCRIPT collected on patients undergoing surgical procedures in both inpatient and outpatient

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settings. Additional details on the Peds-NSQIP can be found in the user guide. [11]

We evaluated patients undergoing: pyloromyotomy, cholecystectomy, ostomy reversal,

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and appendectomy. Patients undergoing cholecystectomy were stratified into 2 groups by the indication for surgery: cholecystitis and biliary dyskinesia (BD). Likewise,

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appendectomy was also separated by primary diagnosis: non perforated appendicitis

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(NPA) and perforated appendicitis (PA) to delineate the different wound classifications for the procedures. Using the current wound classification algorithm, the procedures

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were classified as clean (pyloromytomy), clean-contaminated (cholecystectomy for BD, ostomy reversal), contaminated (appendectomy for NPA, cholecystitis) and dirty

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(appendectomy for PA). Incidence of SSI (classified as superficial, deep and organ

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space), re-operation and re-admission were then analyzed for each procedure and

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wound classification. These rates were then compared to observed rates, which were defined based on the historic data derived from the era of open surgery in adult patients.[10, 12-14] No such data exist for the pediatric surgical population.

Results A total of 10,424 records were included. NPA accounted for the largest patient group. There was a difference in expected versus actual rates of infection following multiple procedures as demonstrated by Table 1. Pyloromyotomy, a clean case, had a 0.7% SSI rate with a re-admission rate 3.1%. Ostomy reversal, a clean contaminated case, had an

ACCEPTED MANUSCRIPT SSI rate of 6.9%. Appendectomy for NPA and laparoscopic cholecystectomy for cholecystitis, both contaminated cases, had SSI rates of only 2.1%and <1%, respectively.

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Appendectomy for perforated appendicitis, a dirty procedure, had a 9.1 % SSI rate, below the expected rate for dirty cases in adults. [13] Re-operations and re-admission

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rates ranged from <1 to 9%. Though no correlation was seen with rates of SSI, there was a linear increase with re-operations and re-admissions by case complexity and

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elective/urgent nature. (Table)

Discussion

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Using a risk-adjusted national database capturing pediatric surgical patients, we investigated whether the current wound classification system was an accurate tool to

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determine risk of SSI in pediatric patients undergoing select procedures. We found some

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remarkable differences in the expected versus actual SSI rates. According to the Peds-

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NSQIP user file, appendectomy for acute appendicitis is considered a contaminated case and an ostomy reversal is considered a clean-contaminated case. Despite an expected higher rate of SSI for an appendectomy, we found a higher SSI rate in patients that underwent an ostomy reversal when compared to patients that underwent an appendectomy for acute appendicitis (6.9% and 2.1%, respectively). Moreover, while appendectomy for perforated appendicitis, a dirty case, had a 9.1% infectious rate in our study, the traditional adult literature reports wound infection rates that can exceed 40%. [13] This indicates that the SSI rate for dirty/contaminated cases may be lower than previously reported.

Table

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Similar to our findings, in one retrospective study of the NSQIP database, the authors

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found that the rates of SSI in contaminated and dirty cases were lower than previously reported. [10] In the plastic surgery literature, a study including over 15,000 patients

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found that although wound classification was a significant predictor of overall complication rate, reoperation and mortality, it was not an adequate predictor of SSI.

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wound classification groupings in children.

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[15] To our knowledge, this study is the first of its kind to assess SSI rates across the

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Although widely used, wound classification systems have come under scrutiny recently. Data have been published revealing that there is inconsistent classification of post-

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operative wounds. In one study there was only 56% concordance when pediatric

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surgical cases were reviewed at 11 participating institutions. [8] Another study including

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colorectal cases found wound misclassification over 20% of the time. [9] As seen in a survey of pediatric surgeons, there is also poor consensus on how to classify wounds in neonatal surgery. [16]

The misclassification of wounds can affect the rates of SSI across wound classification groups. Wounds classified as clean-contaminated which should otherwise have been contaminated can cause the rate of SSI in clean-contaminated cases to be higher than expected, while the rate of SSI in contaminated cases will be lower than expected. In an appendectomy for non-perforated appendicitis, for example, the wound classification

ACCEPTED MANUSCRIPT should be contaminated, unless there is purulence or perforation. This case can be misclassified as a clean-contaminated case, which would theoretically affect the rate of

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SSI in this wound classification. These support a need for a simpler classification system

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which will mitigate the error of misclassification and improve its predictive value.

With the widespread use of laparoscopy in pediatric surgery, one must consider the

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impact of minimally invasive techniques on wound infection rates. When compared to

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open cases, lower SSI rates have been reported for laparoscopic techniques in appendectomy [17-20] and resection of bowel in cases of inflammatory bowel disease.

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[21] A study of the trend of laparoscopic appendectomy among centers in the Pediatric Health Information System (PHIS) showed laparoscopy rising over a 12 year period while

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wound infections dropped in inverse proportion.[22] The classification system was

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developed in the open era, however, laparoscopy doesn’t pose the same SSI risks for

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some operations and the morbidity of wound infections is much smaller with the short incision which further questions the validity of the wound classification system.

If current wound classification systems are an imperfect predictor of risk of SSI in pediatric patients, then SSI may not be the most fitting tool to use as a benchmark of quality of care in this population. A revision of the wound classification schema is warranted so as to better reflect modern day surgical practice with consideration for the role of laparoscopy. This may further improve its predictive ability in relation to SSI and quality of care measures.

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In addition to SSI, others measures, such as re-admission and re-operation rates, may

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need to be incorporated as benchmarks for hospital quality of care in order to create a more composite score, which may better reflect quality of care. Re-operations and re-

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admission rates ranged from <1% to 9% in our data set. These show a linear increase with case complexity and elective/urgent nature. Readmission rate has been

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investigated as a measure of quality of care. [23, 24] While a large proportion of hospital

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readmissions occur at different hospitals[25], most re-admissions related to an index procedure in the Peds-NSQIP dataset are tracked and all re-admissions are typically

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captured within the 30-day period. These tools need to be further investigated to better

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define their role in measures of care within the Peds-NSQIP.

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This study was the first to use a large database in order to assess whether wound class

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was predictive of SSI risk in pediatric patients. Using Peds-NSQIP allowed data capture from various institutions around the country and provided a large number of patients that met inclusion criteria. This study, however, is not without limitations. One of the most striking limitations is that data is not available on the administration of antibiotic prophylaxis in these patients, which has been proven to play a role in the development of an SSI. [26]

This study demonstrates that current wound classifications systems do not reflect surgical risk in children and remain questionable tools for benchmarking surgical care in

ACCEPTED MANUSCRIPT children. Additional investigations are necessary in order to modify and revise current wound classification systems and establish well-defined criteria to serve as benchmarks

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for quality of surgical care in pediatric patients. Also, a role for an integrated scoring systems with other potential measures need to be further evaluated. With the changing

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landscape in healthcare, the establishment of such a system is a necessity in order to

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justly assess the quality of care provided to patients.

ACCEPTED MANUSCRIPT References

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1. Magill SS, Edwards JR, Bamberg W, et al: Multistate point-prevalence survey of health care-associated infections. The New England journal of medicine 370:1198-1208, 2014 2. Anderson DJ, Kirkland KB, Kaye KS, et al: Underresourced hospital infection control and prevention programs: penny wise, pound foolish? Infection control and hospital epidemiology 28:767-773, 2007 3. II RDS: The Direct Medical Costs of Healthcare-Associated Infections in U.S. Hospitals and the Benefits of Prevention, in Prevention CfDCa (ed), 2009 4. Stone PW, Braccia D, Larson E: Systematic review of economic analyses of health care-associated infections. American journal of infection control 33:501-509, 2005 5. Garner JS: CDC guideline for prevention of surgical wound infections, 1985. Supersedes guideline for prevention of surgical wound infections published in 1982. (Originally published in November 1985). Revised. Infection control : IC 7:193-200, 1986 6. Simmons BP: Guideline for prevention of surgical wound infections. American journal of infection control 11:133-143, 1983 7. Devaney L, Rowell KS: Improving surgical wound classification--why it matters. AORN journal 80:208-209, 212-223, 2004 8. Levy SM, Lally KP, Blakely ML, et al: Surgical wound misclassification: a multicenter evaluation. Journal of the American College of Surgeons 220:323-329, 2015 9. Turrentine FE, Giballa SB, Shah PM, et al: Solutions to intraoperative wound classification miscoding in a subset of American College of Surgeons National Surgical Quality Improvement Program patients. The American surgeon 81:193197, 2015 10. Ortega G, Rhee DS, Papandria DJ, et al: An evaluation of surgical site infections by wound classification system using the ACS-NSQIP. The Journal of surgical research 174:33-38, 2012 11. : User Guide for the 2013 ACS NSQIP Pediatric Participant Use Data File (PUF), American College of Surgeons National Surgical Quality Improvement Program - Pediatric, 2014 12. Cruse PJ FR: The epidemiology of wound infection. A 10-year prospective study of 62,939 wounds. Surg Clin North America 60:27-40, 1980 13. Culver DH, Horan TC, Gaynes RP, et al: Surgical wound infection rates by wound class, operative procedure, and patient risk index. National Nosocomial Infections Surveillance System. Am J Med 91:152S-157S, 1991 14. Hart D, Postlethwait RW, Brown IW, Jr., et al: Postoperative wound infections: a further report on ultraviolet irradiation with comments on the recent (1964) national research council cooperative study report. Ann Surg 167:728-743, 1968

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15. Mioton LM, Jordan SW, Hanwright PJ, et al: The Relationship between Preoperative Wound Classification and Postoperative Infection: A MultiInstitutional Analysis of 15,289 Patients. Arch Plast Surg 40:522-529, 2013 16. Vu LT, Nobuhara KK, Lee H, et al: Conflicts in wound classification of neonatal operations. Journal of pediatric surgery 44:1206-1211, 2009 17. Groves LB, Ladd MR, Gallaher JR, et al: Comparing the cost and outcomes of laparoscopic versus open appendectomy for perforated appendicitis in children. The American surgeon 79:861-864, 2013 18. Katsuno G, Nagakari K, Yoshikawa S, et al: Laparoscopic appendectomy for complicated appendicitis: a comparison with open appendectomy. World journal of surgery 33:208-214, 2009 19. Lin HF, Wu JM, Tseng LM, et al: Laparoscopic versus open appendectomy for perforated appendicitis. Journal of gastrointestinal surgery : official journal of the Society for Surgery of the Alimentary Tract 10:906-910, 2006 20. Taqi E, Al Hadher S, Ryckman J, et al: Outcome of laparoscopic appendectomy for perforated appendicitis in children. Journal of pediatric surgery 43:893-895, 2008 21. Mahida JB, Asti L, Deans KJ, et al: Laparoscopic bowel resection for pediatric inflammatory bowel disease. The Journal of surgical research, 2015 22. Gasior AC, St Peter SD, Knott EM, et al: National trends in approach and outcomes with appendicitis in children. Journal of pediatric surgery 47:2264-2267, 2012 23. Quality AfHRa: Medicaid Medical Directors Learning Network 24. Kuhmerker K HT: The Commonwealth Fund: pay-for-performance in state Medicaid programs: a survey of state Medicaid directors and programs., 2007 25. Khan A, Nakamura MM, Zaslavsky AM, et al: Same-Hospital Readmission Rates as a Measure of Pediatric Quality of Care. JAMA Pediatr 3, 2015 26. Khoshbin A, So JP, Aleem IS, et al: Antibiotic Prophylaxis to Prevent Surgical Site Infections in Children: A Prospective Cohort Study. Ann Surg 262:397-402, 2015

ACCEPTED MANUSCRIPT Table: Incidence of surgical site infection, re-operation and re-admission by wound classification in pediatric surgical procedures

4.7 0.7

0.7 0

0

1.5

0.2

0.7

6.9

1-5 1.2

1-5 7.3 7.0

1.3 0.5

0.7

0.5

7.3

2.1

1.0

9.1

3-11 0.7

0.5

10-17 2.3

>27 3.2

3.3

2.5

2.7

8.6

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SSI: Surgical Site Infection; NPA – Non perforated appendicitis; PA – perforated appendicitis

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PA

0.5 0

0.9

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3.1

Dirty

1.3 0.1

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0.5 0.2

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Pyloromyotomy Superficial SSI Deep SSI Organ Space SSI Total Observed SSI rate Total Expected SSI rate Re-operation Readmission

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Clean

Wound Classification (%) Clean Contaminated Contaminated Ostomy Cholecystectomy reversal Cholecytectomy NPA (cholecystitis)