Evidence-Based Update to the U.S. Centers for Disease Control and Prevention and Healthcare Infection Control Practices Advisory Committee Guideline for the Prevention of Surgical Site Infection: Developmental Process

Abstract

Recommendations in the “Guideline for Prevention of Surgical Site Infection, 1999” were based on experts' selective interpretation of the scientific evidence. Effective 2009, the U.S. Centers for Disease Control and Prevention (CDC) and its Healthcare Infection Control Practices Advisory Committee (HICPAC) updated their guideline development process. This is a narrative summary of the updated process focusing on key changes and challenges specific to the Guideline for Prevention of Surgical Site Infection. The guideline development process now incorporates evidence-based methodology and provides explicit links between the evidence and the recommendations using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) method. There is also participation by professional surgical societies, an updated guideline structure (core and procedure-specific sections), additional planned related manuscripts (introductions to the guideline and research opportunities), and new proposed venues for publication.

The new CDC and HICPAC “Guideline for the Prevention of Surgical Site Infection” represents a substantial advancement from recommendations for infection control practices based on expert opinion to evidence-based practices. The new structure is meant to facilitate future updates, in particular, those addressing specialty or procedure-specific surgical site infection prevention questions. Increased presence by the surgical community through the professional surgical societies' engagement in the guideline development process, lead authorship of related manuscripts, and proposed publication in the surgical literature not only increase adherence by the surgical community, but also promote an ongoing collaboration with public health and other partners in a multidisciplinary approach to SSI prevention.

In 1982 the “Guideline for Prevention of Surgical Wound Infections” was published [1]. On the basis of the consensus expert opinion of eight physicians and surgeons reviewing the scientific data, the guideline addressed only incisional wounds, included recommendations both for and against the adoption of measures, and a recommendation categorization scheme to “reflect the degree of scientific backing and the strength with which they would recommend it” [2,3]. The 1985 revision clarified ambiguities in the previous recommendations and provided new information on pre-operative hair removal and operating room ventilation [4]. Most recently, the 1999 guideline adopted the term “surgical site infection” (SSI) to include both incisional (from skin to deep soft tissues) and organ/space infections [5,6]. This update represented a consensus of CDC and its new advisory committee on infection control [7,8].

The Healthcare Infection Control Practices Advisory Committee (HICPAC) is a federal advisory committee of the CDC and the Department of Health and Human Services (HHS), composed of 14 voting public members from the fields of infection control, infectious disease, healthcare epidemiology, health policy, health services research, public health, surgery, and related fields. In addition, there are non-voting ex-officio and liaison representatives from professional organizations and other federal agencies. The primary activity of the committee is to provide recommendations and advice to the CDC on periodic updating of existing guidelines and development of new infection prevention and control guidelines. Strengths of CDC and HICPAC guidelines include that the integration of multidisciplinary and public input (e.g., decision making conducted in public meetings and draft documents published in the Federal Register for public comment), in addition to a methodology that is systematic, transparent, and clearly defined [9,10].

In the 1999 guideline, based on experts' selective interpretation of the evidence, recommendations were based “whenever possible…on data from well-designed scientific studies,” or “strong theoretical rationale and suggestive evidence in the absence of confirmatory scientific knowledge” [6]. The update to the guideline represents a substantial step forward to a rigorous, systematic, evidence based-practice with a systematic review of the evidence and a clear link between the strength of the recommendation and the quality of the evidence [1,4,6,10,11].

What's New?

Participants

In addition to the CDC, HICPAC, its non-voting liaison, and ex-officio representatives from professional organizations and other federal agencies, a multidisciplinary team of 35 additional SSI prevention experts have contributed to the process, including 12 surgeons. For the first time, there is official representation by non-traditional public health partners including the American College of Surgeons, the American Academy of Orthopaedic Surgeons, the Surgical Infection Society-North America, the Musculoskeletal Infection Society, and the Association of periOperative Registered Nurses. Additional national and international experts provided expertise in general and orthopedic surgery, biofilm, and the environmental sciences. The University of Pennsylvania Health System's Center for Evidence-based Practices (UPHS-CEBP) contributed expertise in evidence-based methodology and together with CDC and HICPAC leads comprised the core writing group.

Structure

The guideline is divided into a main core section, with recommendations intended to be generalizable across surgical specialties, and a new procedure-specific section, focused on an individual high-volume, high human and economic burden procedure. This new structure is meant to serve as a targeted and effective way to provide timely guideline development, updates, and response to emerging needs in addressing key clinical questions [10]. The procedure-specific section focuses on prosthetic joint arthroplasties. Approximately 1.2 million arthroplasties are performed in the United States annually [12]. By 2030, there is a projected increase in the number of primary arthroplasties to 5.2 million procedures, increased revision burden to 430,000 procedures, and increased infection burden from 1.4% to 6.5% for total hip arthroplasties and from 1.4% to 6.8% for total knee arthroplasties [13 –16]. Deep infections will then account for 47.5% of all revision hip and 65.5% of revision knee arthroplasties, as compared with 8.4% and 16.8%, respectively, in 2005 [16].

Methodology

CDC and HICPAC's guideline development methodology has been updated to address emerging challenges, including the immense and rapidly growing evidence base, emerging infectious diseases, increasing attention to healthcare-associated infections, the need to communicate priority recommendations to providers, threats from commercial and political bias, and the need to develop and update guidelines more quickly and increase transparency [10]. The incorporation of evidence-based practice to the development process is achieved through targeted systematic reviews of the best available evidence and by providing explicit links between the evidence and the resultant recommendations using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) method [10,17]. Since 2000 the GRADE Workgroup, composed of researchers and guideline developers with an interest in methodology, has worked to develop one worldwide system to rate the quality of evidence (very low, low, moderate, or high) and strength of the recommendations (weak or strong) [17]. Although other approaches to grading levels of evidence and strength of recommendations exist, the multiple advantages of GRADE over these other systems have led dozens of professional organizations to adopt it as the method of choice [18 –21]. The categorization scheme for recommendations has also been updated. Now all Category I recommendations are considered strong recommendations and should be implemented equally. Only the quality of the evidence distinguishes between IA and IB recommendations, and IC are required by state or federal regulation irrespective of level of supporting evidence [10]. This updated methodology will allow for more frequent and timely updates to existing recommendations as additional evidence becomes available and addressing new, emerging, targeted key questions. The quality of studies and level of evidence to which federal recommendations, with national policy implications, are based, may differ from those issued by professional societies.

Manuscripts

Four additional manuscripts (two related to the core and two related to the prosthetic joint arthroplasty sections, respectively) will be published with the guideline. Authored by leaders in SSI prevention who served as content experts on the guideline and the CDC, these documents complement the updated guideline structure, now focused on the evidence based recommendations and GRADE tables. The “Introduction to the CDC and HICPAC Guideline for Prevention of Surgical Site Infection” (for each the core and prosthetic joint arthroplasty sections, separately) address general background information. The “Surgical Site Infection Prevention Research Opportunities” and “Future Research Opportunities in Periprosthetic Joint Infection Prevention Research” compile research questions based on evidence gaps identified during the guideline development process and additional questions derived by the content experts. These manuscripts reinforce the collaboration between clinical and public health in defining research priorities.

Publication

Previous CDC and HICPAC SSI guidelines were published in infection control journals, followed by summary statements in the surgical literature [1,4,6,9,22]. In 1982 Simmons stated: “…to prevent surgical wound infections, personnel who perform the operation must take the lead in instituting prevention measures…” [1]. To further engage the surgical community and capitalize on the multidisciplinary collaboration already established in the guideline development process, publishing in the general and orthopedic surgery literature will be important.

Developmental Process

Key topics and questions

Following a review of topics covered in the 1999 guideline and more recent guidance on SSI prevention, CDC and content experts identified 29 potential topics with >600 related questions for consideration [6,23 –26]. The five core and seven prosthetic joint arthroplasty topics included in the guideline update were selected because they were deemed to be high priority; address key clinical questions; address vague or outdated recommendations or unresolved issues from the previous guideline; have potential prevention strategies or policy implications; and allow for a more timely completion of the guideline (Table 1). Content expert questions were submitted to UPHS-CEBP to formulate the final key questions. The patient characteristics, types of intervention or exposure, control, and outcome (PICO) format was applied, a recommended method to improve queries in evidence-based searches [27]. In the end, there were a total of 10 core key questions (13 sub-questions) and 10 arthroplasty key questions (18 sub-questions).

Table 1.

CDC and HICPAC Guideline for the Prevention of Surgical Site Infection—Key Topics

Core section	Prosthetic joint arthroplasty section
• Parenteral antimicrobial prophylaxis	• Blood transfusion
• Non-parenteral antimicrobial prophylaxis	• Systemic immunosuppressive therapy
• Glycemic control	• Intra-articular corticosteroid injection
• Normothermia	• Anticoagulation
• Oxygenation	• Orthopedic space suit
• Antiseptic prophylaxis	• Post-operative antimicrobial prophylaxis duration with drain use
	• Biofilm

CDC = Centers for Disease Control and Prevention; HICPAC = Healthcare Infection Control Practices Advisory Committee.

Broad literature search

A list of Medical Subject Heading (MeSH^®) search terms and keywords was generated based on the key questions. Separate SSI and prosthetic joint arthroplasty SSI literature searches (studies in English, from 1998 through December 2011 for the prosthetic joint arthroplasty section and April 2014 for the core section) were performed in Ovid-MEDLINE^®, Ovid-MEDLINE^® In-Process and other non-indexed citation (PREM^®), Embase^®, and the Cochrane^® library (28-31). Studies published prior to 1998 were eligible for inclusion if suggested by the content experts, included in the 1999 guideline, or in a published systematic review. Randomized controlled trials, systematic reviews, meta-analyses and guidelines published by an organized body (e.g., hospital, committee, national/international body, or professional organization) with relevance to a key question were included. Complete exclusion and special inclusion criteria are outlined in Table 2.

Table 2.

CDC and HICPAC Guideline for the Prevention of Surgical Site Infection- Exclusion and Special Inclusion Criteria

Exclusion criteria
• Not relevant to one or more of the key questions
• Not a clinical practice guideline, systematic review, randomized control trial (Core and Prosthetic joint arthroplasty sections), or observational study (Prosthetic joint arthroplasty section only)
• Not in English
• Full text not available
• Surgical site infection not reported as an outcome
• Oral medicine/dental health
• All patients described as “dirty” surgical procedures except for aqueous iodophor question
• Not a primary wound closure
• Wound protector post-incision
• For Key question 1 Parenteral antimicrobial prophylaxis—excluded placebo controlled and studies comparing different antimicrobial prophylactic agents
• For Key question 2 Non-parenteral antimicrobial prophylaxis—excluded gentamicin collagen sponges because the product is not approved by the Food and Drug Administration (FDA)
• For Key questions 8–10 Antiseptic prophylaxis—excluded vaginal antisepsis, electrolyzed ionized solution (not FDA approved for intraoperative surgical site irrigation), and povidone iodine powder spray studies
• For Prosthetic joint arthroplasty key questions—exclude non-arthroplasty studies
• Prosthetic joint infection diagnosis and biofilm diagnosis studies that did not also address surgical site infection prevention were excluded
• For Key question 11 Blood transfusion—excluded epoeitin administration studies

Special inclusion criteria
• Pediatric studies
• Animal and in-vitro basic science studies only for biofilm
• Timing of antimicrobial prophylaxis relative to cord clamping in high-risk Cesarean sections
• Antiseptic irrigation or topical application prior to wound closure
• Platelet gel prior to wound closure
• Preoperative shower (non-Staphylococcus aureus specific)

CDC = Centers for Disease Control and Prevention; HICPAC = Healthcare Infection Control Practices Advisory Committee.

Title and abstract screen and full text review

In addition to the 5,487 studies found through the literature search, 104 other were recommended by content experts, and 168 more were identified as potentially relevant studies cited in the 1999 guideline. Of the 5,759 studies that underwent title and abstract screening, 896 were selected for full text review, of which 170 were chosen for data extraction (134 core and 36 arthroplasty section studies). Titles and abstracts were screened by one independent reviewer (four individuals total, two from UPHS-CEBP, one from CDC, and one content expert). A 10% random sample of the studies was generated to determine agreement, for inclusion based on title and abstract screening, beyond chance between raters. Full-text review was performed by two independent reviewers (same individuals performing the title and abstract screen plus one additional CDC reviewer). Inclusion and exclusion criteria are found in Table 2.

Targeted literature searches

Prosthetic joint arthroplasty section topics with few or no hits on the broad search were selected for targeted literature searches expanded to include observational studies (prospective and retrospective with concurrent control, prospective and retrospective pre-post quasi-experimental) and topic specific MeSH^® and key terms. Prioritized topics included blood transfusion, immunosuppressive therapy, anticoagulation, use of orthopedic space suit, and biofilm. Animal and in-vitro basic science studies were also considered for the biofilm targeted review.

From evidence tables to recommendations

Randomized controlled trial, systematic review, and non-randomized controlled study evidence table templates were developed to facilitate the extraction of standardized data elements between extractors. For each key question, comparators and outcomes of interest were identified and incorporated into GRADE tables to then rate the quality of the evidence using the GRADE method [10]. Narrative summaries drafted from the GRADE tables were used to develop recommendations that link the quality of the evidence to the strength of the recommendation. Category I recommendations are all considered strong and should be implemented equally. Only the quality of the evidence distinguishes between IA (high to moderate) and IB (weak) recommendations; IC recommendations, regardless of the quality of the evidence, are required by state or federal legislation (Table 3).

Table 3.

Updated CDC and HICPAC Categorization Scheme for Recommendations [10]

Category IA	A strong recommendation supported by high to moderate quality evidence suggesting net clinical benefits or harms.
Category IB	A strong recommendation supported by low-quality evidence suggesting net clinical benefits or harms or an accepted practice (e.g., aseptic technique) supported by low to very low-quality evidence.
Category IC	A strong recommendation required by state or federal regulation
Category II	A weak recommendation supported by any quality evidence suggesting a tradeoff between clinical benefits and harms
No recommendation/unresolved issue	An unresolved issue for which there is either low to very low-quality evidence with uncertain tradeoffs between benefits and harms or no published evidence on outcomes deemed critical to weighing the risks and benefits of a given intervention.

CDC = Centers for Disease Control and Prevention; HICPAC = Healthcare Infection Control Practices Advisory Committee.

Finalizing the guideline

The draft guideline was reviewed by the content experts, discussed during multiple HICPAC meetings, and modified based on their input. In September 2013 the updated draft guideline was submitted to CDC clearance prior to posting in the Federal Register for two 30-day public comment periods (between January and May 2014). Comments and proposed changes were reviewed by HICPAC. Comments posted to the Federal Register stated that the initial literature search for the core section, completed in July 2011, was outdated and that more recent evidence warranted further evaluation. The literature search for the core section was updated through April 2014 and the new data were incorporated. The final draft was approved by HICPAC in July 2015, prior to submission to CDC for final clearance.

Challenges

In addition to the methodological and operational challenges previously described, challenges specific to surgical site infection prevention have become apparent [10]. Suboptimal indexing adversely impacts the ability to identify articles of interest in a literature search. Clear indication of “surgical wound infection” or “surgical site infection” as the primary or secondary outcome of interest will improve literature search precision. In addition, they and the publisher should index or specify them as keywords. This facilitates the National Library of Medicine's MEDLINE^® indexers' ability to assign the appropriate MeSH^® or key terms. The heterogeneity of surgical site infection definitions, or the failure to provide such information, limits the ability to compare results between studies. If SSI is not the primary outcome of interest (e.g., most effective techniques for managing normothermia) a broad search using SSI MeSH^® or key terms is unlikely to yield the appropriate studies. Finally, topics for which the primary literature is not necessarily in the medical literature (e.g., biofilm) may warrant broadening the search to non-medical databases.

Conclusion

The new CDC and HICPAC “Guideline for the Prevention of Surgical Site Infection” represents a substantial advancement from recommendations for infection control practices based on expert opinion to evidence-based practices. The new structure is expected to facilitate future updates. The professional surgical societies' engagement in the development process, lead authorship of related manuscripts by academic leaders in SSI prevention, and proposed publication of the guideline recommendations in the surgical literature will not only increase adherence by the surgical community, but will also promote an ongoing collaboration with public health and other partners in a multidisciplinary approach to SSI prevention.

Footnotes

Author Disclosure Statement

No conflict of interest to disclose.

The findings and conclusions in this report are those of the author and do not necessarily represent the official position of the U.S. Centers for Disease Control and Prevention. The contents of this publication does not necessarily reflect the views or policies of the Department of Health & Human Services, nor does mention of trade names, commercial products, or organizations imply endorsement by the U.S. Government. The author assumes full responsibility of the accuracy and completeness of the ideas presented.

References

Simmons

. CDC guidelines on infection control. Infect Control, 1982; 3:187–196.

Haley

. CDC guidelines on infection control. J Hosp Infect, 1981; 2:117–118.

McGowan

Jr . Categories for infection control: A new approach from the Centers for Disease Control. Infect Control, 1981; 2:97–100.

Garner

. 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. Infect Control, 1986; 7:193–200.

Horan

, Gaynes

, Martone

, et al. CDC definitions of nosocomial surgical site infections, 1992: A modification of CDC definitions of surgical wound infections. Infect Control Hosp Epidemiol, 1992; 13:606–608.

Mangram

, Horan

, Pearson

, et al. Guideline for prevention of surgical site infection, 1999. Hospital Infection Control Practices Advisory Committee. Infect Control Hosp Epidemiol, 1999; 20:250–278.

U.S. Centers for Disease Control and Prevention. Healthcare Infection Control Practices Advisory Committee. 2015. Accessed September 18, 2015. Available from: http://www.cdc.gov/hicpac/.

Garner

. The CDC Hospital Infection Control Practices Advisory Committee. Am J Infect Control, 1993; 21:160–62.

Lee

. A new surgical site infection (SSI) prevention guideline. Surg Infect, 2000; 1:127–131.

10.

Umscheid

, Agarwal

, Brennan

; Healthcare Infection Control Practices Advisory C. Updating the guideline development methodology of the Healthcare Infection Control Practices Advisory Committee (HICPAC). Am J Infect Control, 2010; 38:264–273.

11.

Polk

Jr. , editor. Infection and the Surgical Patient. Edinburgh: Churchill Livingstone; 1982.

12.

Agency for Healthcare Research and Quality. Healthcare Cost and Utilization Project net (HCUPnet). 2012 Nationwide Inpatient Sample (NIS). 2015. Accessed Sept 18, 2015. Available from: http://hcupnet.ahrq.gov/.

13.

Kurtz

, Ong

, Lau

, et al. Projections of primary and revision hip and knee arthroplasty in the United States from 2005 to 2030. J Bone Joint Surg Am, 2007; 89:780–785.

14.

Kurtz

, Lau

, Ong

, et al. Future young patient demand for primary and revision joint replacement: National projections from 2010 to 2030. Clin Orthop Rel Res, 2009; 467:2606–2612.

15.

Kurtz

, Lau

, Schmier

, et al. Infection burden for hip and knee arthroplasty in the United States. J Arthroplasty, 2008 Oct; 23:984–991.

16.

Kurtz

, Ong

, Schmier

, et al. Future clinical and economic impact of revision total hip and knee arthroplasty. J Bone Joint Sur Am, 2007; 89:144–151.

17.

Grading of Recommendations Assessment Development and Evaluation Working Group. GRADE Working Group. Accessed September 18, 2015. Available from: http://www.gradeworkinggroup.org/.

18.

Atkins

, Briss

, Eccles

, et al. Systems for grading the quality of evidence and the strength of recommendations II: Pilot study of a new system. BMC Health Serv Res, 2005; 5:25.

19.

Atkins

, Eccles

, Flottorp

, et al. Systems for grading the quality of evidence and the strength of recommendations I: Critical appraisal of existing approaches The GRADE Working Group. BMC Health Serv Res, 2004; 4:38.

20.

Brozek

, Akl

, Alonso-Coello

, et al. Grading quality of evidence and strength of recommendations in clinical practice guidelines. Part 1 of 3. An overview of the GRADE approach and grading quality of evidence about interventions. Allergy, 2009; 64:669–677.

21.

Guyatt

, Oxman

, Vist

, et al. GRADE: An emerging consensus on rating quality of evidence and strength of recommendations. BMJ, 2008; 336:924–926.

22.

Polk

Jr ., Simpson

, Simmons

, Alexander

. Guidelines for prevention of surgical wound infection. Arch Surg, 1983; 118:1213–1217.

23.

Anderson

, Kaye

, Classen

, et al. Strategies to prevent surgical site infections in acute care hospitals. Infect Control Hosp Epidemiol, 2008; 29:S51–S61.

24.

National Institute for Health and Clinical Science. NICE Clinical Guideline 74-Surgical site infection. Prevention and treatment of surgical site infection. London, England, 2008. Accessed September 28, 2015. Available from: http://www.nice.org.uk/nicemedia/pdf/CG74NICEGuideline.pdf.

25.

Uckay

, Harbarth

, Peter

, et al. Preventing surgical site infections. Exp Rev Anti Infect Ther, 2010; 8:657–670.

26.

World Health Organization. WHO guidelines for safe surgery: 2009: Safe surgery saves lives. Geneva, Switzerland. 2009. Accessed September 18, 2015. Available from: http://apps.who.int/iris/bitstream/10665/44185/1/9789241598552_eng.pdf.

27.

Straus

. Evidence-based Medicine: How to Practive and Teach EBM. 3rd ed. Edinburgh, UK; and New York, NY: Elsevier/Churchill Livingstone; 2005.

28.

Embase. Embase®. Accessed September 18, 2015. Available from: http://www.embase.com/.

29.

Ovid Technologies. Ovid-MEDLINE® In-Process and other non-indexed citation (PREM®). Accessed September 18, 2015. Available from: http://www.ovid.com/site/products/ovidguide/premdb.htm.

30.

Ovid Technologies. Ovid-MEDLINE®. 2015. Accessed September 18, 2015. Available from: http://www.ovid.com/site/catalog/DataBase/901.jsp.

31.

The Cochrane Library. Cochrane®. Accessed September 18, 2015. Available from: http://www.thecochranelibrary.com/view/0/index.html.