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수술의 예방적 항생제 사용 김상일 가톨릭의대 서울성모병원 2010. 10. 26 심사평가원실무교육 1

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수술 방적 항생제 사

가 병원

2010. 10. 26 심사평가원실무

1

Introduction

• Surgical site infection (SSI)

– Infection at the site of an operation (usually an

incision) that is caused by the operation

– Defined by clinical, laboratory, survey data

• 2nd~3rd most common cause of Hospital

Acquired Infection

– 2~5% of extra-abdominal operation

– 20% of intra-abdominal operation

2

Impact of SSI, 1990-1995

Infected Uninfected

Mortality 7.8% 3.5%

ICU admission 29% 18%

Readmission 41% 7%

Median initial L.O.S

11 days 6 days

Median total L.O.S

18 days 7 days

Initial excess cost + $3,644

Total excess cost + $5,038(NNIS, 1997)

3

나라 병원 감염

SSTI

8%

Other

6%

SSI

15%

BSI

14%

GI inf

8%

UTI

31%

Pneumonia

17%

“1996년도 국내 병원 감염률 조사연구”, 한 병원감염관리학회, 1997.

4

Consequences of surgical site infection

• Additional hospital stay

– Mean 20.4 days*

• Additional cost

– 3,317,812~3,945,829 (won) *

• Morbidity & mortality

* “수술부 감염이 의료비용 재원기간에 미치는 향에 한 연구”,

한병원감염관리학회, 1999

5

SSI Risk Factors

• Patients– Age

– Nutrition status

– Diabetes

– Smoking

– Coexistent infections at a remote body site

– Colonization with microorganisms

– Altered immune response

– Length of preoperative stay

• Operation– Duration of surgical scrub

– Skin antisepsis

– Preoperative shaving

– Preoperative skin prep

– Duration of operation

– Antimicrobial prophylaxis

– Operating room ventilation

– Inadequate sterilization of instruments

– Foreign material in the surgical site

– Surgical drain

– Surgical technique

6

Antibiotic Prophylaxis

• NRC Wound Classification

– Clean Surgical Procedures *

– Clean Contaminated Procedures

– Contaminated Procedures*

– Dirty Procedures*

--------------------

* not prophylaxis, but treatment

+Prosthesis

7

Antibiotic Prophylaxis -Benefit

• G.I. procedures (including appendicitis)

• Oropharyngeal procedures

• Obstetrical and gynecological procedures

• Vascular (abd. & leg) procedures, prosthesis

• Open heart procedures

• Orthopaedic hardware placement

• Craniotomy

• Some “clean” procedures

8

Optimal Antibiotic Prophylaxis

• Which drug should you use?

• Which route should you use?

• When should you start?

• How much should you give?

• How long should antibiotics be continued?

9

Common Pathogens for SSI

• SSI for a skin wound at any site

: Staphylococcus aureus

• Additional pathogens

– Head & Neck : Oral anaerobes

– Below the waist (colon & GY)

: Anaerobes / E. coli (Enterobacteriaceae)

– Insertion of prosthesis

: CNS, S. aureus

10

Published Guidelines on Selection of Antibiotics for Surgical Prophylaxis

Operations Recommendation

Colon Cefoxitin or cefotetan / Cefazolin + metronidazole

Ampicillin/sulbactam

Hysterectomy Cefazolin, cefotetan, cefoxitin, cefuroxime, ampicillin/sulbactam

Cardiothoracic Cefazolin, cefuroxime, cefamandole

If b-lactam allergy or high risk of MRSA

: vancomycin, clindamycin

Hip or Knee Cefazolin, cefuroxime

If b-lactam allergy or high risk of MRSA

: vancomycin, clindamycin

Vascular Cefazolin, cefuroxime

If b-lactam allergy : vancomycin, clindamycin

11

Use of Vancomycin

• Major Surgical Procedures

– Cardiac and vascular procedures

– Total hip replacement

• High risk of MRSA

– At institutions with a high rate of MRSA infections

: > 20% of surgical wound infections

• Maximum 2 doses

– Repeat dose in massive blood loss, > 6 hours op.

• Risk of VRE

12

Route of Administration

• IV : Majority of procedure

• Oral : Gut decontamination in colon surgery

• Topical (paste, irrigation)

: only in Ophthalmologic procedure

13

Timing of Antibiotic Prophylaxis

• Grouping of timing of prophylaxis

– Early : 2 – 24 hours prior to incision

– Preoperative : 0 – 2 hours prior to incision

– Perioperative : 0 – 3 hours after incision

– Postoperative : 3 – 24 hours after incision

14

Prophylactic Antibiotics & Infection Rate

15

First – Dosing Timing

• All other antibiotics (Cefazolin, etc)

: Start 30 – 60 min. before incision

• Vancomycin

: Start within 120 min. before incision

• Infuse before tourniquet inflated in OS cases

• Infuse after cord clamp in C-section

• Oral : 19 hours before the surgery in colon

prep.

16

Size of Patient and Size of Dose

• In Obese patients

: Cefazolin levels lower than in non-obese

patients at same dose

: Cefazolin dose changed from 1g to 2g

Infection rate at 1g : 16.5%

Infection rate at 2g : 5.6%

17

Antibiotic Dose

Antibiotics Half-life (h) Standard dose Weight-based dose recommendation

Aztreonam 1.5-2 1-2g 2g maximum

Ciprofloxacin 3.5-5 400mg 400mg

Cefazolin 1.2-2.5 1-2g 20-30mg/kg

(<80kg, use 1g;

>80kg, use 2g)

Cefuroxime 1-2 1.5g 50mg/kg

Cefamandole 0.5-2.1 1g

Cefoxitin 0.5-1.1 1-2g 20-40mg/kg

Cefotetan 2.8-4.6 1-2g 20-40mg/kg

18

Antibiotic Dosing

• Redose during surgery if the procedure is still

underway 2 half-lives the drug is given

• Ensure an adequate, weight-based dose of

the antibiotics

19

Antibiotic Dose

Antibiotics Half-life (h)

Standard dose

Weight-based dose

recommendation

Recommended redosing interval, hr

Aztreonam 1.5-2 1-2g 2g maximum 3-5

Ciprofloxacin 3.5-5 400mg 400mg 4-10

Cefazolin 1.2-2.5 1-2g 20-30mg/kg

(<80kg, use 1g; >80kg, use 2g)

4

Cefuroxime 1-2 1.5g 50mg/kg 3-4

Cefamandole 0.5-2.1 1g 3-4

Cefoxitin 0.5-1.1 1-2g 20-40mg/kg 3

Cefotetan 2.8-4.6 1-2g 20-40mg/kg 6

20

Effect of Duration of Operation

Op. Duration Infection Incidence

< 3 hours 0/17

3 – 4 hours 2/25 (8%)

> 4 hours 5/14 (36%)

(Kaieser, Ann Surgery 198:525, 1983)

21

Duration of Prophylaxis

• Most studies have confirmed efficacy of

prophylactic antibiotics within 24 hours

after surgery

• Many studies have shown efficacy of a

single does

• Whenever compared, the shorter course

has been as effective as the longer course

• Cardiothoracic Surgery : <72 hours (?)

22

Problems with prolonged antibiotic prophylaxis

• Increased risk for C. difficile infection

• Increased risk for resistant bacteria

• Increased risk for drug reaction

• Increased incidence of MRSA

infection/colonization

• Increased cost

23

Goal of Prophylactic Antibiotics

• Prevent postop. Infection of the surgical site

• Prevent postop. Infectious morbidity and

mortality

• Reduce the duration and cost of health care

• Produce no adverse effects

• Have no adverse consequences for the

microbial flora

24

Antimicrobial prophylaxis for specific surgery

25

Upper GI surgery

• Lower incidence of infect than lower GI surgery– Gastric acidity, low number of commensals

Procedure Likely pathogens

Antimicrobial

Esophageal, gastroduodenal in high risk patients*

Enteric gram-negative bacilli,

Gram-positive cocci

cefazolin

Endoscopic esophageal dilatation, varix ligation, percutanues endoscopic gastrostomy

*: gastric ulcer surgery, duodenal ulcer with hemorrhage, obstruction or perforation, morbid obesity, malignancy, H2-block or proton-pump inhibitor

26

Biliary-tract surgery

Procedure Likely pathogens

Antimicrobial

Biliary tract surgery or ERCP in high risk patients*

Enteric gram-negative bacilli, enterococci, clostridia

Cefazolin, cefoxitin, cefotetan

*: age> 70 years, acute cholecystitis, nonfunctioning gall bladder, obstructive jaundice, previous history of cholangitis, or common duct stones

27

Colorectal surgery

Procedure Likely pathogens Antimicrobial

Colorectal surgery Enteric gram-negative bacilli, enterococci, anaerobes

Oral: neomycin plus

erythromycin base

IV: cefoxitin, cefotetan, or

cefazolin+ Metronidazole

28

Appendectomy

Procedure Likely pathogens

Antimicrobial

Appendectomy without perforation (if, perforation (+) à

therapeutic usage)

Enteric gram-negative bacilli, anaerobes, enterococci

Cefoxitin or cefotetan

29

Other general surgery

Procedure Likely pathogens

Antimicrobial

Inguinal herninorraphy with mesh repair

Staphylococci, gram-negative bacilli

Ampicillin/sulbactam*, cefazolin

Mastectomy: still controvertial.

Staphylococci Cefazolin

*: Ann Surg 2001;233:26-33

30

Gynecologic surgery

Procedure Likely pathogens Antimicrobial

Hysterectomy, vaginal or abdominal

Enteric gram-negative bacilli, anaerobes, enterococci, group B strep

Cefoxitin, cefotetan, or cefazolin

31

Obstetric surgery

Procedure Likely pathogens

Antimicrobial

Cesarean section, in a patient with active labor or premature rupture of membranes

Enteric gram-negative bacilli, anaerobes, enterococci, group B strep.

Cefazolin after cord clamping

32

Thoracic surgery

Procedure Likely pathogens Antimicrobial

Cardiac: pacemaker or defibrillator insertion, and open heart surgery

Staphylococci, corynebacteria, enteric gram-negative bacilli

Cefazolin, cefuroxime,

(or vancomycin)

Non-cardiac: lobectomy, pneumonectomy, chest tube insertion with severe chest trauma such as hemothorax

(not in spontaneous pneumothorax)

Staphylococci, streptococci, enteric gram-negative bacilli

33

Vascular surgery

Procedure Likely pathogens Antimicrobial

Arterial surgery involving prosthetic material, abdominal aorta, groin incision, leg amutation for arterial insufficiency

Staphylococci, streptococci

Cefazolin

(or vancomycin)

34

Orthopedic surgery

Procedure Likely pathogens Antimicrobial

Orthopedic surgery: therapeutic usage for open fracture, not indicated in arthroscopic surgery

Staphylococci Cefazolin

(or vancomycin)

35

Neurosurgery

Procedure Likely pathogens Antimicrobial

Neurosurgery Staphylococci Cefazolin

(or vancomycin)

36

Head & Neck surgery

Procedure Likely pathogens Antimicrobial

Head and neck: with incision through oral or pharyngeal mucosa, cochlear implant

Oral anaerobes, gram-negative bacilli, Staphylococci

Ampicillin/sulbactam, clindamycin plus gentamicin, or

cefazolin

37

Urologic surgery

Procedure Likely pathogens

Antimicrobial

Genitourinay: high-risk patients only*

Enteric gram-negative bacilli, enterococci

Ciprofloxacin, trimethoprim-

sulfamethoxazole

*: urine culture positive or unavailable, preoperative bladder catheter, transrectal prostatic biopsy

38

Opthalmic surgery

Procedure Likely pathogens Antimicrobial

Opthalmic surgery: lack of data

Staphylococci, streptococci, gram-negative bacilli including

Pseudomonas aeruginosa

Topical, subconjunctival, or

IV

39

£ 수술 절개 전 방적 항생제 :절개 1시간 내여

£ 수술 종료 후 방적 항생제 여 간 : POD 5내

£ 방적 항생제 택– 1 cephalosporin계 항생제 metronidazole 병

합사– 2 cephaslosporin계 항생제 단 사 또

metronidazole 병합 사– 3 cephalosporin계 항생제 단 사 또

metronidazole 병합 사– Aminoglycoside계 수술 가 반드시 필 하다고 하

항문학회 고안(2007.9)40

평가 상 수술

상과 수술 평가

흉 과 심 수술,CABG 심평원,진흥원

정형 과고 절 전/ 치환술 심평원,진흥원

슬 절 전치환술 심평원,진흥원

수술 심평원,진흥원

절제술 심평원,진흥원

담낭절제술 심평원

산 과적출술 심평원,진흥원

제 절개술 심평원

41

평가 지표지표 평가 준 평가

피 절개 전 1시간 내 여 비 100% 심평원,진흥원

항생제 병 여 비 0% 심평원

피해야 할항생제조합

병 여비

2개 상 cepha계 항생제 0% 진흥원

cepha+penicillin 0% 진흥원

cepha+aminoglycoside 0% 진흥원

3rd cepha 0% 심평원,진흥원

aminoglycoside 0% 심평원,진흥원

수술 후항생제

여중단시

1 내

단축고

심평원,진흥원(시범)

1~3 내 심평원,진흥원(시범)

3~5 내 심평원,진흥원(시범)

5~7 내 심평원,진흥원(시범)

7 초과 심평원,진흥원(시범)

평균 여수

원 중(경 +비경 ) 심평원

원 중 + 퇴원약 심평원

퇴원 항생제 처방 비 0% 심평원

42

2011년 수술 방적 항생제 사추 평가 계획(안)

• 7개 진료과 11종 수술

– 존 상 : 4개 진료과 8종 수술

– 신규 상 : 3개 진료과 3종 수술

진료과 수술 종 수술

존 평가 상

수술 전절제술, 아전절제술

수술 결 절제술, 직 및 에스 절제술, 결 및 직 전절제술

복강경하담낭수술 복강경하 담낭절제술

정형 과고 절치환술 고 절전치환술, 고 절 치환술

슬 절치환술 슬 절전치환술

산 과적출술 전 적출술, 질식 전적출술

제 절개술 1태아 신 초회 초산 및 경산, 반복

흉 과 심 수술 동맥간 회 조 술, 판 형술, 공판 치환술

‘10년 신규 평가

신경 과 개 술

개 술 또 개절제술, 혈종제거 한 개 술, 종양절제

한 개 술, 뇌동맥 수술, 뇌동정맥 형적출술, 개강내혈

문합술, 뇌엽절단술, 뇌엽절제술, 개강내뇌신경수술

비뇨 과 전 절제술전 적출술, 전 정낭전적출술,

경 적전 절제술, 택적 전 화술

안 과 녹내 녹내 수술, 녹내 플란 삽 술

43

평가 지표

• 총 12개 지표

– 존 : 9개 지표

– 신규 : 3개 지표 추가

지표 존 8개 수술 신규 3개 수술

방적 항생제

지표

최초

여시

○ 피 절개 전 1시간 내에 최초 방적 항생제 여 ○○

(녹내 수술 제 )

○ Proximal tourniquet inflation 전 방적 항생제 여 슬 절치환술 적 -

항생제 택

○ Aminoglycoside 계열 여 ○ ○

○ 3 상 Cephalosporin 계열 여 ○ ○

○ 방적 항생제 병 여 ○ ○

여 간

○ 퇴원 시 항생제 처방 ○ ○

○ 방적 항생제 총 평균 여 수(병원 내 여+퇴원처방) ○ ○

○ 항생제 알러지 ○ ○

○ ASA class ○ ○

환 지표

○ 수술 후 혈당 조절 환 비 심 수술 적 -

○ 적절한 제 환 비○

(슬 절치환술 제 )-

○ 수술 후 정상 체 지 환 비 ○ -

44

평가공개

45

Summary

• Prophylaxis should be started shortly before incision

• “Short duration” generally as effective as “long”

• Prophylaxis should be discontinued in most operations within 24 hours after the incision is closed (except cardiac op)

• Prolonged prophylaxis results in resistance, adverse patient events, and increasing cost.

46

Main References

• Bratzler DW, Houck PM, Surgical Infection Prevention Guidelines Writers Workgroup. Antimicrobial Prophylaxis for Surgery: An Advisory Statement from the National Surgical Infection Prevention Project.Clinical Infectious Diseases 2004; 38:1706–15

• 양수. 방적 항균 법. 항생제 제3판2008;59-63

• Classen DC, Evans RS, Pestotnik SL, Horn SD, Menlove RL, Burke JP. The timing of prophylactic administration of antibiotics at the risk of surgical-wound infection. N Engl J Med. 1992;326(5):281-6

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