美国CDC-SSI预防指南2017

Centers for Disease Control and Prevention Guideline for the Prevention of Surgical Site Infection,2017

Sandra I.Berríos-Torres,MD;Craig A.Umscheid,MD,MSCE;Dale W.Bratzler,DO,MPH;Brian Leas,MA,MS;Erin C.Stone,MA;Rachel R.Kelz,MD,MSCE;Caroline E.Reinke,MD,MSHP;Sherry Morgan,RN,MLS,PhD;Joseph S.Solomkin,MD;John E.Mazuski,MD,PhD;E.Patchen Dellinger,MD;Kamal M.F.Itani,MD;Elie F.Berbari,MD;John Segreti,MD;Javad Parvizi,MD;Joan Blanchard,MSS,BSN,RN,CNOR,CIC;

George Allen,PhD,CIC,CNOR;Jan A.J.W.Kluytmans,MD;Rodney Donlan,PhD;William P.Schecter,MD;for the Healthcare Infection Control Practices Advisory Committee

Invited Commentary

Supplemental content

Author Affiliations:Author

affiliations are listed at the end of this article.

Group Information:The Healthcare Infection Control Practices Advisory Committee members are listed at the end of this article.

Corresponding Author:Erin C.Stone,MA,Division of Healthcare Quality Promotion,Centers for Disease Control and Prevention,1660Clifton Rd NE,Mail Stop A07Atlanta,GA 30329(v ).

干电池手机Clinical Review &Education

JAMA Surgery |Special Communication

S urgical site infections(SSIs)are infections of the incision or organ or space that occur after surgery.1Surgical patients ini-

tially seen with more complex comorbidities2and the emer-gence of antimicrobial-resistant pathogens increase the cost and challenge of treating SSIs.3-5The prevention of SSI is increasingly im-portant as the number of surgical procedures performed in the United States continues to rise.6,7Public reporting of process,out-come,and other quality improvement measures is now required,8,9 and reimbursements10for treating SSIs are being reduced or de-nied.It has been estimated that approximately half of SSIs are preventable by application of evidence-based strategies.11

Methods

This guideline focuses on select areas for the prevention of SSI deemed important to undergo evidence assessment for the ad-vancement of the field.These areas of focus were informed by feed-back received from clinical experts and input from the Healthcare Infection Control Practices Advisory Committee(HICPAC),a fed-eral advisory committee to the Centers for Disease Control and Prevention(CDC).This guideline was a systematic review of the literature.No institutional review board approval or participant in-formed consent was necessary.

This guideline’s recommendations were developed based on a targeted systematic review of the best available evidence on SSI prevention conducted in MEDLINE,EMBASE,CINAHL,and the Cochrane Library from1998through April2014.To provide explicit links between the evidence and recommendations,a modified Grad-ing of Recommendations,Assessment,Development,and Evalua-tion(GRADE)approach was used for evaluating the quality of evi-dence and determining the strength of recommendations.12-15The methods and structure of this guideline were adopted in2009by CDC and HICPAC.16,17The present guideline does not reevaluate sev-eral strong recommendations offered by CDC’s1999Guideline for Prevention of Surgical Site Infection18that are now considered to be accepted practice for the prevention of SSI.These recommen-dations are found in eAppendix1of the Supplement.A detailed description of the Guideline Questions,Scope and Purpose,and Methods,as well as the Evidence Summaries supporting the evi-dence-based recommendations,can also be found in eAppendix1 of the Supplement.

The detailed literature search strategies,GRADE Tables,and Evidence Tables supporting each section can be found in eAppen-dix2of the Supplement.Results of the entire study selection pro-cess are shown in the Figure.Of5759titles and abstracts screened,896underwent full-text review by2independent reviewers.Full-text articles were excluded if:1)SSI was not

Figure.Results of the Study Selection Process

CDC indicates Centers for Disease Control and Prevention;GRADE,Grading of Recommendations,Assessment,Development,and Evaluation;RCTs,randomized controlled trials;SRs,expand;and SSI,surgical site infection.

Clinical Review&Education Special Communication CDC Guideline for the Prevention of Surgical Site Infection,2017

E2JAMA Surgery Published online May3,2017jamasurgery

reported as an outcome;2)all patients included had“dirty”surgi-cal procedures(except for Q2addressing the use of aqueous iodo-phor irrigation);3)the study only included oral or dental health procedures;4)the surgical procedures did not include primary closure of the incision in the operating room(eg,orthopedic pin sites,thoracotomies,or percutaneous endoscopic gastrostomy [PEG]procedures,or wounds healing by secondary intention);or 5)the study evaluated wound protectors used postincision. Evidence-based recommendations in this guideline were cross-checked with those from other guidelines identified in a system-atic search.

CDC completed a draft of the guideline and shared it with the expert panel for in-depth review and then with HICPAC and mem-bers of the public at committee meetings(June2010to July2015). CDC posted notice in the Federal Register for the following2peri-ods of public comment:from January29to February28,2014,and from April8to May8,2014.Comments were aggregated and re-viewedwiththewritinggroupandatanotherHICPACmeeting.Based on the comments received,the literature search was updated,and new data were incorporated into a revised draft.Further input was provided by HICPAC during a public teleconference in May2015.Fi-nalHICPACinputwasprovidedviaavotebymajorityruleinJuly2015. After final HICPAC input,CDC updated the draft document and obtained final CDC clearance and coauthor approval.

Recommendation Categories

Recommendations were categorized using the following standard system that reflects the level of supporting evidence or regulations:•Category IA:A strong recommendation supported by high to mod-erate–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(eg,aseptic technique)supported by low to very low–quality evidence.

•Category IC:A strong recommendation required by state or fed-eral regulation.

•Category II:A weak recommendation supported by any quality evidence suggesting a trade-off between clinical benefits and harms.

•No recommendation/unresolved issue:An issue for which there is low to very low–quality evidence with uncertain trade-offs be-tween the benefits and harms or no published evidence on out-comes deemed critical to weighing the risks and benefits of a given intervention.

Recommendations

Core Section

In2006,approximately80million surgical procedures were per-formed in the United States at inpatient hospitals(46million)7and ambulatory hospital–affiliated or freestanding(32million)settings.6 Between2006and2009,SSIs complicated approximately1.9%of surgical procedures in the United States.19However,the number of SSIs is likely to be underestimated given that approximately50% of SSIs become evident after discharge.20Estimated mean attrib-utablecostsofSSIsrangefrom$10443in2005USdollarsto$25546 in2002US dollars per infection.3-5,11Costs can exceed$90000per infection when the SSI involves a prosthetic joint implant21,22or an antimicrobial-resistant organism.23The Core Section of this guide-line(eAppendix1of the Supple

ment)includes recommendations for the prevention of SSI that are generalizable across surgical proce-dures,with some exceptions as mentioned below.

Parenteral Antimicrobial Prophylaxis

1A.1.Administer preoperative antimicrobial agents only when indi-cated based on published clinical practice guidelines and timed such that a bactericidal concentration of the agents is established in the serum and tissues when the incision is made.(Category IB–strong recommendation;accepted practice.)

1A.2.No further refinement of timing can be made for preoperative antimicrobial agents based on clinical outcomes.(No recommenda-tion/unresolved issue.)

1B.Administer the appropriate parenteral prophylactic antimicro-bial agents before skin incision in all cesarean section procedures. (Category IA–strong recommendation;high-quality evidence.)

1C.The literature search did not identify randomized controlled trials that evaluated the benefits and harms of weight-adjusted paren-teral antimicrobial prophylaxis dosing and its effect on the risk of SSI.Other organizations have made recommendations based on ob-servational and pharmacokinetic

data,and a summary of these rec-ommendations can be found in the Other Guidelines section of the narrative summary for this question(eAppendix1of the Supple-ment).(No recommendation/unresolved issue.)

1D.The search did not identify sufficient randomized controlled trial evidence to evaluate the benefits and harms of intraoperative re-dosing of parenteral prophylactic antimicrobial agents for the pre-vention of SSI.Other organizations have made recommendations based on observational and pharmacokinetic data,and a summary of these recommendations can be found in the Other Guidelines sec-tion of the narrative summary for this question(eAppendix1of the Supplement).(No recommendation/unresolved issue.)

1E.In clean and clean-contaminated procedures,do not administer additional prophylactic antimicrobial agent doses after the surgical incision is closed in the operating room,even in the presence of a drain.(Category IA–strong recommendation;high-quality evidence.)

Nonparenteral Antimicrobial Prophylaxis

2A.1.Randomized controlled trial evidence suggested uncertain trade-offs between the benefits and harms regarding intraopera-tive antimicrobial irrigation(eg,intra-abdominal,deep,or subcuta-neous tis

sues)for the prevention of SSI.Other organizations have made recommendations based on the existing evidence,and a sum-mary of these recommendations can be found in the Other Guide-lines section of the narrative summary for this question(eAppen-dix1of the Supplement).(No recommendation/unresolved issue.)

2A.2.The search did not identify randomized controlled trials that evaluated soaking prosthetic devices in antimicrobial solutions be-fore implantation for the prevention of SSI.(No recommendation/ unresolved issue.)

CDC Guideline for the Prevention of Surgical Site Infection,2017Special Communication Clinical Review&Education

2B.1.Do not apply antimicrobial agents(ie,ointments,solutions,or powders)to the surgical incision for the prevention of SSI.(Cat-egory IB–strong recommendation;low-quality evidence.)

2B.2.Application of autologous platelet-rich plasma is not neces-sary for the prevention of SSI.(Cate

gory II–weak recommendation; moderate-quality evidence suggesting a trade-off between clinical benefits and harms.)

2C.Consider the use of triclosan-coated sutures for the prevention of SSI.(Category II–weak recommendation;moderate-quality evi-dence suggesting a trade-off between clinical benefits and harms.)

2D.Randomizedcontrolledtrialevidencesuggesteduncertaintrade-offs between the benefits and harms regarding antimicrobial dress-ings applied to surgical incisions after primary closure in the oper-ating room for the prevention of SSI.(No recommendation/ unresolved issue.)

Glycemic Control

3A.1.Implement perioperative glycemic control and use blood glu-cose target levels less than200mg/dL in patients with and with-out diabetes.(Category IA–strong recommendation;high to mod-erate–quality evidence.)

3A.2.The search did not identify randomized controlled trials that evaluated lower(<200mg/dL)or narrower blood glucose target lev-els than recommended in this guideline nor the optimal timing,du-r

ation,or delivery method of perioperative glycemic control for the prevention of SSI.Other organizations have made recommenda-tions based on observational evidence,and a summary of these rec-ommendations can be found in the Other Guidelines section of the narrative summary for this question(eAppendix1of the Supple-ment).(No recommendation/unresolved issue.)

3B.The search did not identify randomized controlled trials that evaluated the optimal hemoglobin A1C target levels for the preven-tion of SSI in patients with and without diabetes.(No recommen-dation/unresolved issue.)

Normothermia

4.Maintain perioperative normothermia.(Category IA–strong rec-ommendation;high to moderate–quality evidence.)

5.The search did not identify randomized controlled trials that evaluated strategies to achieve and maintain normothermia,the lower limit of normothermia,or the optimal timing and duration of normothermia for the prevention of SSI.Other organizations have made recommendations based on observational evidence,and a summary of these recommendations can be found in the Other Guidelines section of the narrative summary for this question (eAppendix1of the Supplement).(No re

commendation/ unresolved issue.)

Oxygenation

6A.Randomizedcontrolledtrialevidencesuggesteduncertaintrade-offs between the benefits and harms regarding the administration of increased fraction of inspired oxygen(F IO

)via endotracheal in-tubation during only the intraoperative period in patients with nor-mal pulmonary function undergoing general anesthesia for the pre-vention of SSI.(No recommendation/unresolved issue.)6B.For patients with normal pulmonary function undergoing gen-

eral anesthesia with endotracheal intubation,administer increased F IO

sis压片during surgery and after extubation in the immediate postop-erative period.To optimize tissue oxygen delivery,maintain peri-operative normothermia and adequate volume replacement.(Cat-egory IA–strong recommendation;moderate-quality evidence.)

6C.Randomizedcontrolledtrialevidencesuggesteduncertaintrade-offs between the benefits and harms regarding the administration

of increased F IO

via face mask during the perioperative period in patients with normal pulmonary function undergoing general an-esthesia without endotracheal intubation or neuraxial anesthesia(ie, spinal,epidural,or local nerve blocks)for the prevention of SSI.(No recommendation/unresolved issue.)

6D.Randomized controlled trial evidence suggested uncertain trade-offs between the benefits and harms regarding the admin-

istration of increased F IO

via face mask or nasal cannula during only the postoperative period in patients with normal pulmonary function for the prevention of SSI.(No recommendation/ unresolved issue.)

7.The search did not identify randomized controlled trials that evalu-

ated the optimal target level,duration,and delivery method of F IO

2 for the prevention of SSI.Other organizations have made recom-mendations based on observational studies,and a summary of these recommendations can be found in the Other Guidelines section of the narrative summary for this question(eAppendix1of the Supple-ment).(No recommendation/unresolved issue.)

Antiseptic Prophylaxis

8A.1.Advise patients to shower or bathe(full body)with soap(an-timicrobial or nonantimicrobial)or an antiseptic agent on at least the night before the operative day.(Category IB–strong recommenda-tion;accepted practice.)

8A.2.Randomized controlled trial evidence suggested uncertain trade-offs between the benefits and harms regarding the optimal timing of the preoperative shower or bath,the total number of soap or antiseptic agent applications,or the use of chlorhexidine glu-conate washcloths for the prevention of SSI.(No recommendation/ unresolved issue.)

8B.Perform intraoperative skin preparation with an alcohol-based antiseptic agent unless contraindicated.(Category IA–strong rec-ommendation;high-quality evidence.)

8C.Application of a microbial sealant immediately after intraopera-tive skin preparation is not necessary for the prevention of SSI.(Cat-egory II–weak recommendation;low-quality evidence suggesting a trade-off between clinical benefits and harms.)

8D.The use of plastic adhesive drapes with or without antimicro-bial properties is not necessary for the prevention of SSI.(Category II–weak recommendation;high to moderate–quality evidence sug-gesting a trade-off between clinical benefits and harms.)

9A.Consider intraoperative irrigation of deep or subcutaneous tis-sues with aqueous iodophor solution for the prevention of SSI.In-traperitoneal lavage with aqueous iodophor solution in contami-nated or dirty abdominal procedures is not necessary.(Category II–weak recommendation;moderate-quality evidence suggesting a trade-off between clinical benefits and harms.)

Clinical Review&Education Special Communication CDC Guideline for the Prevention of Surgical Site Infection,2017

E4JAMA Surgery Published online May3,2017jamasurgery

螺旋板冷凝器9B.The search did not identify randomized controlled trials that evaluated soaking prosthetic devices in antiseptic solutions before implantation for the prevention of SSI.(No recommendation/ unresolved issue.)

10.Randomized controlled trial evidence was insufficient to evalu-ate the trade-offs between the benefits and harms of repeat appli-cation of antiseptic agents to the patient’s skin immediately before closing the surgical incision for the prevention of SSI.(No recommendation/unresolved issue.)

Prosthetic Joint Arthroplasty Section

Preventioneffortsshouldtargetallsurgicalproceduresbutespecially those in which the human and financial burden is greatest.In2011, primary total knee arthroplasty accounted for more than half of the 1.2million prosthetic joint arthroplasty procedures(primary and re-vision)performed in the United States,followed by total hip arthro-plastyandhiphemiarthroplasty.24Primaryshoulder,elbow,andankle arthroplasties are much less common.By2030,prosthetic joint ar-throplasties are projected to increase to3.8million procedures per year.25-27

Infection is the most common indication for revision in total knee arthroplasty28and the third most common indication in total hip arthroplasty.28By2030,the infection risk for hip and knee arthroplasty is expected to increase from2.18%22to6.5% and6.8%,respectively.25In addition,owing to increasing risk and the number of individuals undergoing prosthetic joint arthro-plasty procedures,the total number of hip and knee prosthetic joint infections is projected to increase to221500cases per year by2030,at a cost of more than$1.62billion.22,25The Prosthetic Joint Arthroplasty section contains recommendations that are applicable to these procedures(eAppendix1of the Supplement).

Blood Transfusion

11A.Available evidence suggested uncertain trade-offs between the benefits and harms of blood transfusions on the risk of SSI in prosthetic joint arthroplasty.Other organizations have made rec-ommendations on this topic,and a reference to these recommen-dations can be found in the Other Guidelines section of the narra-tive summary for this question(eAppendix1of the Supplement). (No recommendation/unresolved issue.)

11B.Do not withhold transfusion of necessary blood products from surgical patients as a means to prevent SSI.(Category IB–strong recommendation;accepted practice.)

Systemic Immunosuppressive Therapy

12and13.Available evidence suggested uncertain trade-offs between the benefits and harms of systemic corticosteroid or other immunosuppressive therapies on the risk of SSI in pros-thetic joint arthroplasty.Other organizations have made recom-mendations based on the existing evidence,and a summary of these recommendations can be found in the Other Guidelines section of the narrative summary for this question(eAppendix1of the Supplement).(No recommendation/unresolved issue.)14.For prosthetic joint arthroplasty patients receiving systemic corticosteroid or other immunosuppressive therapy,recommen-dation1E applies:in clean and clean-contaminated procedures, do not administer additional antimicrobial prophylaxis doses after the surgical incision is closed in the operating room,even in the presence of a drain.(Category IA–strong recommendation;high-quality evidence.)

Intra-articular Corticosteroid Injection

15and16.Available evidence suggested uncertain trade-offs between the benefits and harms of the use and timing of preop-erative intra-articular corticosteroid injection on the incidence of SSI in prosthetic joint arthroplasty.Other organizations have made recommendations based on observation

遥控飞机制作al studies,and a summary of these recommendations can be found in the Other Guidelines section of the narrative summary for this ques-tion(eAppendix1of the Supplement).(No recommendation/ unresolved issue.)

Anticoagulation

17.Available evidence suggested uncertain trade-offs between the benefits and harms of venous thromboembolism prophylaxis on the incidence of SSI in prosthetic joint arthroplasty.Other organizations have made recommendations based on the existing evidence,and these references can be found in the Other Guide-lines section of the narrative summary for this question(eAppen-dix1of the Supplement).(No recommendation/unresolved issue.)

Orthopedic Surgical Space Suit

18.Available evidence suggested uncertain trade-offs between the benefits and harms of orthopedic space suits or the health care personnel who should wear them for the prevention of SSI in prosthetic joint arthroplasty.(No recommendation/unresolved issue.)

Postoperative Antimicrobial Prophylaxis Duration

With Drain Use瓷管电阻器

19.In prosthetic joint arthroplasty,recommendation1E applies:in clean and clean-contaminated procedures,do not administer addi-tional antimicrobial prophylaxis doses after the surgical incision is closed in the operating room,even in the presence of a drain.(Cat-egory IA–strong recommendation;high-quality evidence.)

Biofilm

20A.Availableevidencesuggesteduncertaintrade-offsbetweenthe benefits and harms regarding cement modifications and the pre-vention of biofilm formation or SSI in prosthetic joint arthroplasty. (No recommendation/unresolved issue.)

20B.The search did not identify studies evaluating prosthesis modi-fications for the prevention of biofilm formation or SSI in prosthetic joint arthroplasty.(No recommendation/unresolved issue.)

20C.The search did not identify studies evaluating vaccines for the prevention of biofilm formation or SSI in prosthetic joint arthro-plasty.(No recommendation/unresolved issue.)

CDC Guideline for the Prevention of Surgical Site Infection,2017Special Communication Clinical Rev

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