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Prophylactic Antibiotics in Otolaryngology. Department of Otolaryngology University of Ottawa Grand Rounds January 7 th , 2008. James P. Bonaparte, MD, MSc PGY -2. Objectives. Review the basics of antibiotic prophylaxis in surgery

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Prophylactic antibiotics in otolaryngology l.jpg

Prophylactic Antibiotics in Otolaryngology

Department of Otolaryngology

University of Ottawa

Grand Rounds January 7th, 2008

James P. Bonaparte, MD, MSc

PGY-2


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Objectives

  • Review the basics of antibiotic prophylaxis in surgery

  • Discuss common otolaryngology procedures in which antibiotic prophylaxis is commonly used

  • Discuss controversies related to antibiotic prophylaxis in Otolaryngology

  • Gain an understanding of the evidence available supporting the use of prophylaxis in Otolaryngology

  • Understand the potential evidence based risks associated with prophylactic antibiotic use


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Overview

  • Surgical Site Infections

    • Definitions

    • Pathogenesis

  • Antibiotic Prophylaxis Theory

  • Prophylaxis in Otolaryngology

    • Head and Neck Surgery

    • Tonsillectomies

    • Septorhinoplasty

    • Nasal Packing

    • Otology


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Prophylactic Antibiotics

Surgical Site Infections


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Surgical Site Infections (SSI)

  • CDC’s National Nosocomial Infections Surveillance System (USA)1

    • Monitors reported trends in infections

    • Surgical Site Infections (SSI) are third most common Nosocomial Infection

      • 14-16% of all Hospital infections

      • 2/3 were confined to incision

      • 1/3 involved organs/spaces accessed during OR

    • When patients with SSI died

      • 77% were related to SSI

    • A single SSI prolongs stay by 7 days

1-Emori TG et al. Clin Microbiol Rev. 1993


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Consequences of SSI in ENT

  • Increased Post-Op Death

    • Penel et al (2004), Penel et al (2005)

  • Surgical Failure

    • Penel et al (2004), Govaerts et al (1998), Andrews et al (2006), Rodrigo et al (1997), Liu et al (2008)

  • Fever

    • Penel et al (2004), Dhiwakar et al (2006), Burkart et al (2005)

  • Increased Hospital Stay

    • Penel et al (2004), Rodrigo et al (1997 ), Johnson et al (1997), Weber et al (1992), Liu et al (2008)

  • Delay in Radiation Therapy

    • Penel et al (2004), Penel et al (2001)

  • Increase cost

    • Callender et al (1999), Penel et al (2001)


  • Definition of surgical site infection l.jpg

    Definition of Surgical Site Infection

    • NNIS Definition of SSI

      • Superficial Incisional SSI

        • Infection within 30 days involving only skin/subcutaneous tissue of incision AND one of:

          • Purulent Drainage

          • Positive Culture

          • A sign of infection (pain, swelling, redness, heat)

          • A diagnosis by a physician

      • Deep Incisional SSI

        • Infection within 30 days involving fascial and/or muscle layersand one of:

          • Purulence

          • Spontaneous dehiscence or opened by physician due to symptoms

          • Abscess

          • Dx by a physician

      • Organ Space SSI


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    Initiating Factors for SSI

    Creation of wound

    Presence of bacteria

    Susceptible host


    Initiating factors for ssi9 l.jpg

    Initiating Factors for SSI

    Creation of wound

    Presence of bacteria

    Susceptible host


    Initiating factors for ssi10 l.jpg

    Initiating Factors for SSI

    Creation of wound

    Presence of bacteria

    Susceptible host


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    Pathogenesis of SSI

    • Bacterial “Dose” Required for SSI

      • Greater than 105 per gram of tissue increased risk

      • Significantly lower if foreign body present

        • Less than 102 per gram of tissue if silk suture present

  • Bio-Burden of Saliva

    • Approximately 108 bacteria per gram of tissue


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    Factors Influencing SSI

    • Patient Characteristics

      • Systemic Factors

        • Diabetes

        • Nicotine Use

        • Steroid Use

        • Malnutrition

        • Prolonged Hospital Stay

        • Pre-operative Colonization by virulent bacteria

      • Local Factors

        • Tissue Ischemia

        • Non-viable tissue

        • Foreign Bodies

        • Hematoma

        • Dead Space

      • Environment Factors

        • Perioperative Transfusion

  • Preoperative Characteristics

    • Antiseptic Showering

    • Preoperative hair removal – razor vs shave

    • Skin Preparation

    • Surgical team antiseptic

    • Antimicrobial Prophylaxis

  • Operative Characteristics

    • Operating Room – Ventilation, Atire, Drapes,

    • Surgical Technique

    • Excessive electrocautery

  • Post-operative

    • Wound Care

    • Post-operative Antibiotics


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    Factors Influencing SSI

    • Patient Characteristics

      • Systemic Factors

        • Diabetes

        • Nicotine Use

        • Steroid Use

        • Malnutrition

        • Prolonged Hospital Stay

        • Pre-operative Colonization by virulent bacteria

      • Local Factors

        • Tissue Ischemia

        • Non-viable tissue

        • Foreign Bodies

        • Hematoma

        • Dead Space

      • Environment Factors

        • Perioperative Transfusion

  • Preoperative Characteristics

    • Antiseptic Showering

    • Preoperative hair removal – razor vs shave

    • Skin Preparation

    • Surgical team antiseptic

    • Antimicrobial Prophylaxis

  • Operative Characteristics

    • Operating Room – Ventilation, Atire, Drapes,

    • Surgical Technique

    • Excessive electrocautery

  • Post-operative

    • Wound Care

    • Post-operative Antibiotics


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    Principle of Prophylaxis

    “Antibiotic Prophylaxis is warranted when a

    surgical procedure or patient susceptibility poses a greater risk than that associated with the administration of the Drug.”

    How do we calculate Infection Risk?

    How do we calculated Drug Risk?


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    Timing and Purpose of Antimicrobial Prophylaxis

    • Three Primary Methods:

      • Pre-operative Antibiotics

        • Dose given prior to incision

        • Reduces burden of bacteria introduced during OR

      • Post-operative Antibiotics

        • Given for varying number of doses post-op

        • Reduce post-operative contamination

          • Thus reduce infection risk

      • Combination


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    Wound Classification

    • Clean

      • Uninfected wound with no inflammation and the respiratory, alimentary or genital tract is not entered.

        • Closed primarily and using closed drainage

  • Clean-Contaminated

    • Operative wound in which respiratory, alimentary, genital/urinary tracts are entered under controlled conditions.

  • Contaminated

    • Open, fresh or accidental wounds or major breaks in sterile technique or gross spillage from GI tract

  • Dirty/Infected

    • Old traumatic wounds or those with clinical infection or perforated viscera.


  • Assessment of surgical site infections l.jpg

    Assessment of Surgical Site Infections

    • Multiple Assessment Scales

      • Purulence vs No purulence

        • Common in Otology

        • Used in all other areas as well

      • Grades of erythema

        • Head and Neck

      • Combination of symptoms and signs

      • Johnson’s Criteria

        • Most common in head and neck


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    Assessment of Surgical Site Infections

    • Johnson`s Criteria (Johnson et al, 1984)

      • 0: Normal Healing

      • 1+: Erythema around suture line limited to 1cm

      • 2+: 1-5 cm of erythema around suture line

      • 3+: Greater than 5cm of erythema/induration

      • 4+: Purulence either spontaneous or through incision

      • 5+: Orocutaneous fistula formation

    • 4+ and 5+ often used as definition of positive “SSI” in studies

      • 1+ to 3+ considered as expected surgical inflammation


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    Otolaryngology Surgical Site Infections

    Head and Neck


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    Head and Neck

    Clean Procedures


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    Clean Procedures

    • Retrospective Studies

      • Johnson et al (1987)

      • Carrau et al (1991)

      • Slattery et al (1995)

  • Prospective Studies

    • Mustafa et al (1993)

    • Seven et al (2004)

    • Penel et al (2004)

  • Meta-analysis - 0

  • Placebo-Controlled RCT - 0


  • Clean head and neck procedures retrospective l.jpg

    Clean Head and Neck Procedures: Retrospective

    • Johnson et al (1987)

      • Retrospective of 438 patients

        • Thyroidectomy, parathyroidectomy , parotidectomy and submandibular gland excision

        • 20% of patients used prophylactic antibiotics (chart review)

      • SSI=0.7% (3/438)

        • 2 - No antibiotics

        • 1 – Received antibiotics

    • Carrau et al (1991)

      • Retrospective review of 192 Clean Neck Dissections

        • Multiple antibiotics dosing and duration utilized

      • SSI = 6% overall with no difference between those with and without antibiotics

        • Study had low power to detect difference

        • Infection correlated with: Flap-use, prior Radiation, length of surgery


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    Clean Head and Neck Procedures: Retrospective

    • Slattery et al. (1995)

      • Retrospective review of 119 Clean Neck Dissections

      • 25% of patients also underwent other clean procedures

        • Parotidectomies (14), Thyroidectomy (7), tracheotomies (8)

    • Compared short (<24h vs Extended >24h) of antibiotics

      • All patients received Ancef

        • 31 patients received <24h

        • 88 patients received >24h

          • 4% for 48-hours and 70% until drains removed (4.3 days average)

        • Johnson’s Criteria used for SSI definition

      • No infections reported

      • Are Tracheotomies Clean?


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    Clean Head and Neck Procedures: Prospective

    • Mustafa et al (1992)

      • Prospective Double-Blind RCT of 60 patients

      • Included: Parotidectomies, Thyroidectomies, Submandibular Gland Excisions

      • Received either 24h or 7 days of cefotaxime (IM)

      • Used Johnson’s Criteria

        • SSI=11.6% with no difference between groups

          • 13% - 24h Group

          • 10% - 7 day Group

        • No Antibiotic Complications

    • Seven et al (2004)

      • Compared Antibiotic to No Antibiotic in 68 patients

        • 1.5g amp-sulbac q6h for 24h: SSI = 1.7% (1/57)

        • No antibiotics: SSI = 13.3% (7/51)

      • Not true prospective study

        • Control group identified retrospectively and compared

      • Both groups had similar definitions of infections

        • Who assessed for infection in past? How were infections recorded?

        • Johnson’s Criteria would be very difficult to apply retrospectively


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    Clean Head and Neck Procedures: Prospective

    • Penel et al. 2004

      • Prospective study:

      • 221 patients with no prophylactic antibiotics

        • Neck Dissection (114), Thyroidectomy (50), Parotidectomy (7), Skin Resections (34)

        • Johnson’s Criteria

        • Multiple Univariate analysis performed

      • Overall SSI Rate=6.6% (14/212)

        • 100% of these in patients with malignant tumors

          • P=0.06 (too few benign cases to reach significance)

          • Only 38 benign cases

      • Risk Factors

        • Prior Chemotherapy (p=0.0001)

          • 93% (14/15) oh those with Prior Chemo developed a SSI

          • 0/197 in those without Prior Chemo


    Chemotherapy and infection l.jpg

    Chemotherapy and Infection

    • Discussion

      • Chemo affects the immune system

        • Reduced number and function of macrophages/neutrophils

        • B-cell and T-cell Function

          • Diminished opsonizing activity

          • Reduced cellular and humoral immunity

        • Increased susceptibility to pyogenic infections

          • Even if not neutropenic (wolf et al, 1987)

      • Adverse effects last up to 6-months

        • Wolf et al (1987)

      • No Mention of when chemo was given


    Clean head and neck procedures conclusions l.jpg

    Clean Head and Neck ProceduresConclusions

    • Overall Low Incidence of SSI

      • 0%-11.6%

        • 6.6% in Penel et al. (2004) in absence of antibiotics

        • No study has shown effect of antibiotics

      • No reported major complications of antibiotics

    • Antibiotics do not appear to be required in Clean Head and Neck Procedures

    • Future study to assess:

      • Coverage for those with clean H/N surgery with Prior Chemotherapy


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    Head and Neck

    Clean-Contaminated


    Clean contaminated procedures l.jpg

    Clean-Contaminated Procedures

    Definition in Otolaryngology Studies:

    “Skin incision in communication with oral cavity or the aerodigestive tract “

    Common Procedures

    Neck Dissection with communication

    Laryngectomy, Pharyngectomy

    Mandibular procedures

    Floor of mouth resections


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    Review of the Literature

    • 3 Risk Factor Assessments

    • 1 Retrospective Study

    • 10 RCT assessed (1979-2008)

      • Multiple antibiotic regimens

        • Class, Dose, Timing, Duration

      • Two studies did not assess for SSI

        • One assessed for pulmonary complications

        • One assessed for prescribing habits

      • 5/8 studies used Johnson’s Criteria

        • Alternate definition include

          • Presence of purulence or fistula

          • “Clinician impression”

          • Erythema around the surgical site

      • Two compared Antibiotic to placebo

    • 1 Meta-analysis


    Ssi risk factors in ent l.jpg

    SSI Risk Factors in ENT

    • Penel et al. (2001, 2004, 2005)

      • Conducted three studies using same population

        • Used “Johnson’s Criteria”

    • Prospective study (2001) 165 patients

      • Received Clindamycin 900mg IV at incision time then 48h

  • Prospective study (2004) 95 patients

    • Received amox/clav 1g at incision time then 48 hours

  • “Prospective” study (2005)

    • Compared prior two studies retrospectively


  • Risk factors for ssi l.jpg

    Risk Factors for SSI

    • Clindamycin Group (2001)

      • Clean-contaminated procedures – communication with aerodigestive tract

        • Over 30 variables assessed at p<0.05

        • True bonferoni adjusted value p<0.0015

      • Overall SSI= 41.8%

    • Positive Risk Factors – Univariate assessment

      • Tumor stage (p=0.044)

      • Prior Chemo (p=0.008)

      • Duration of hospital stay (p=0.022)*Confounding

      • Laryngectomy stoma (p=0.00008)

      • Laryngeal/hypopharyngeal cancer (p=0.008)


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    Risk Factors for SSI

    • Amox/Clav Group (2004)

      • Clean-contaminated procedures

        • Same variables although included some new ones

      • Overall SSI=50.5%

    • Risk Factors

      • High ETOH consumption (p=0.007)

        • Not included in first study or multivariate analysis

      • Larynx/Hypopharynx (p=0.02)

      • Laryngectomy Stoma (p=0.01)


    Risk factors for ssi37 l.jpg

    Risk Factors for SSI

    • Multivariate analysis – (2005)

      • Compared prior two studies

      • Pooled patients to perform multivariate analysis

        • 25 Parameters assessed with p<0.05

        • Adjusted rate p<0.002

    • Overall SSI rate = 45%

      • No difference between therapies (p=0.17)

  • Univariate Risk Factors

    • Male (p=0.003)

    • Prior Chemo (p=0.009)

    • Hypopharyngeal Cancer (p=0.009)

    • Laryngectomy stoma (p=0.00001)

  • Multivariate Risk Factors

    • Laryngectomy Stoma (p=0.001)


  • Risk factors for ssi discussion l.jpg

    Risk Factors for SSI - Discussion

    • Identified risk factors for

      • Clean-contaminated H/N Patients

      • Who received antibiotics

    • What does this say about those who don’t receive Antibiotics?

      • Nothing

    • Why was Male a risk factor in univariate analysis?

      • Comorbidities? ETHO (significant in one assessment)?

      • This was a European Population

    • Why do laryngectomy stoma’s increase risk of infection, even with 2-days of Abx?

      • Improper coverage

      • Should we cover longer in these patients


    Risk factors for ssi discussion39 l.jpg

    Risk Factors for SSI - Discussion

    • Notable Insignificant Risk Factors

      • Prior Radiation

      • Uni or Bilateral Neck

      • Flap vs No-Flap

      • Recurrence vs Primary


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    Clean Contaminated Surgery Placebo Controlled

    • Becker et al (1979)

      • Clean contaminated H/N surgery of 55 patients

      • Cefazolin Pre-op then q6h for 1 day

        • Infection Rate: 38%

      • Placebo

        • Infection Rate: 87%

  • Johnson et al (1984)

    • Clean contaminated H/N of 80 patients

    • Started “Johnson’s Criteria”

    • 24h of cefotaxime or placebo

      • Abx: 10% infection rate

      • Placebo: 78% infection rate

    • Interestingly, this rate is lower than Clean H/N Study by Mustafa (1993)


  • Clean contaminated surgery double blind rct l.jpg

    Clean Contaminated Surgery Double-Blind- RCT

    • Johnson et al (1984) – 107 patients randomized to one of 4 Groups

      • 15% Overall infection rate

        • Ancef rate

          • 24h: 33%

          • 5-days : 20%

        • Clinda-gent rate

          • 24h: 7%

          • 5-days: 4%

      • Small Sample

        • Small sample for 4-factor comparison

    • No complications

      • No difference in Vestibular function between groups (ENG)

      • No changes in auditory function (Pre/post audiogram)

  • Rodrigo et al (1997) – 159 patients randomized to one of 3 groups

    • 23% infection rate after 24h hours of:

      • No difference between 24h of Ancef, Clavulin or Clinda-gent

      • Small sample for 3-factor comparison

  • No reported complications


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    Clean Contaminated Surgery Double-Blind- RCT

    • Skitarelic et al (2007) – 189 patients randomized to one of 2 groups

      • 24h of Clavulin vs Ancef

        • 22% Overall Infection rate

          • No Significant difference between 24h of

            • Clavulin: 21%

            • Ancef: 24%

          • No significant difference in non-wound related infections (12%)

    • Liu et al (2008) – 50 Patients randomized to one of 2 groups

      • 1 vs 2 days of Clindamycin

        • 24.5% infection rate

          • No difference between 72h vs 24h of clindamycin

        • No reported antibiotic related complication


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    Summary of Comparable RCT


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    Summary of Comparable RCT

    • Comparable Studies

      • All used Johnson’s Criteria for SSI assessment

      • All contained a variety of procedures

    • Discussion

      • Trend for improved rates with longer duration?

        • Is there evidence of increased harm with this?

      • Clindamycin ideal for coverage

      • Does adding Gentamycin improve efficacy?


    Gram negative coverage l.jpg

    Gram Negative Coverage

    • Controversial

      • Cummings suggests to add gram negative if:

        • Hospitalized

        • In Nursing Home

      • No RCT or Meta-analysis specifically looking at Gram Negative Coverage


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    Free-Flap StudiesRandomized Controlled Trials

    • Carroll et al (2003) – 74 patients with flap-reconstruction

      • Infection defined as: Red wound, “swollen” or purulence

      • 11% infection rate (8/74)

      • 8% Developed Fistuas (pharyngeocutaneous)

        • No difference between 24h and 5 day clindamycin

      • 1 Patient Developed c. difficilediarrhea

    • Simons et al (2001) – 62 patients with flap reconstruction

      • 8.1% infection rate

        • No difference between 2-days of IV pip-tazovsPiptazo containing Oral mouthwash and IV Piptazo


    Meta analysis l.jpg

    Meta-Analysis

    • Velanovich V, (1990)

      • Included Head and Neck Studies

      • Clean, Clean-Contaminated

    • Results

      • Prophylactic antibiotics compared to placebo

        • Reduced infection by 43.7% (14.9 to 72.5)

      • Multiple antibiotics compared to Ancef alone

        • Reduced infection by 14% (6.2 to 21.2)

      • Multi drug or 3rd Gen Cephlosporin vs. Single drug

        • 8.3% (2.4 to 14.2) relative difference compared to single Abx

      • No difference between single and multiple days

        • 4.1 (-1.4 to 9.6) relative difference


    Meta analysis discussion l.jpg

    Meta-Analysis - Discussion

    • Poor discussion of Search Strategy

      • Key words? MESH?

      • Included articles with “Similar methods” but did not indicated what this meant

    • Quality assessment

      • No mention of who, how many assessed quality

    • Compared “pertinent factors” but no identification of the factors

      • Did not provide explanation on what variables were being assessed

    • Multidrug and 3rd Gen Cephalosporin considered the same

      • May not be as 3rd Gen Ceph have reduced Gram Positive Coverage


    Clean contaminated surgery conclusions l.jpg

    Clean-Contaminated SurgeryConclusions

    • Evidence to recommend antibiotics to reduce infections for head and neck surgery

    • No evidence to recommend >24h of coverage

    • Trend supporting use of gram negative coverage

      • Future studies needed

    • Studies required to assess influence of prior chemotherapy and prophylaxis

    • Clindamycin appears safe and efficacious

    • No evidence suggesting 24h of antibiotics increases complications or side-effects


    Laryngectomy l.jpg

    Head and Neck

    Laryngectomy


    Laryngectomy literature l.jpg

    Laryngectomy - Literature

    • No RCT, prospective trials or meta-analysis

    • Subgroup analysis from larger studies

    • Case Series


    Laryngectomy and pharyngectomy l.jpg

    Laryngectomy and Pharyngectomy

    • Johnson et al. (1984) – Clinda+Gentamycinvs Ancef

      • 12% infection rate (100% in Ancef Groups, )

      • No patients receiving Clinda+Gent developed infection

    • Rodrigo et al (1997) – Ancef, Clavulin, Clinda-Gent

      • 30% Infection rate (Highest procedure)

      • Did not provide data to allow subgroup comparison

        • Compared multiple procedures, rate not correlated with OR time.

    • Skitarelic et al (2007) – Clavulin vsKeflex

      • 61% Infection rate (Highest procedure)

      • Did not provide data to allow subgroup comparison

        • Compared multiple procedures, rate not correlated with OR time.

    • Coskun et al (2000) – Keflex + Tobramycin, Clinda

      • 38% Infection rate

      • Did not provide data to allow subgroup comparison


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    Laryngectomy

    • Grandis et al (1994)

      • Conducted a pilot study on 10-laryngectomy patients

        • All patients received both IV (24h) and clindamycin solution

        • Assessed effects of oral clindamycin solution

          • 1.5g mouthwash administered pre-op and 6h post-op

          • 900mg/L Clindamycin solution irrigated wound/neck intra-op

        • 0% infection rate

      • Authors cultured neck and oral cavity

        • Neck: 90% reduction in total bacteria count

        • Oral Cavity: 99% reduction in total bacteria count

        • Hemophilus species increased by 71%

          • Gram negative aerobic


    Laryngectomy conclusions l.jpg

    Laryngectomy - Conclusions

    • Procedure appears to have high infection risk

      • Stoma is only identified risk factor in multivariate analysis

  • Insufficient Evidence for Recommendations

    • Clindamycin mouthwash/irrigation

      • Case series shows promising results

    • Data suggests gram negative coverage may be required in addition to clindamycin

      • Johnson et al (1984) and growth of hemophilus when treating with clindamycin

        • Johnson et al (1984) did not report causative bacteria in laryngectomy infections

  • More studies required


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    Prophylactic Antibiotics

    Tonsillectomy


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    Tonsillectomy

    • One of most common ENT procedures

    • Tonsillar bed colonized with bacteria (Telian, 1986)

      • Bacteria thought to contribute to Morbidity

      • 25-34% of patients post-tonsillectomy had + Blood Cultures

        • Walsh et al (1997) and Telian et al (1986)

  • Proposed Effects of Bacterial Contamination

    • Increase pain

    • Increase fever

    • Interfere with normal Diet Resumption

    • Increased post-op bleeding rates

  • Prescribing Practices

    • 12% UK Otolaryngologists use antibiotics

    • 79% of US Otolaryngologits use antibiotics

      • Dhiwakar et al. (2005) and Krishna et al. (2004)


  • Tonsillectomy meta analysis l.jpg

    Tonsillectomy - Meta-analysis

    • Four recently published Meta-Analysis and Systematic Reviews

      • Dhiwakar (2005)

      • Dhiwakar (2006)

      • Burkart et al (2005)

      • Iyer et al (2006)


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    Tonsillectomy - Meta-analysis

    • Dhiwakar et al (2005)

      • Assessed 11 RCT

        • Cefonicid - 1

        • Amox-Clav - 2

        • Amoxicillin - 8

    • Findings:

      • Pain:

        • Only 2/7 studies noted significant reduction in pain

        • Inconsistent measures to perform calculations

      • Analgesia Requirements

        • 1/5 noted significant reduction in requirements

      • Hemorrhage (6 RCT with 472 patients)

        • RR=0.92 (0.45-1.87; p=0.85)

      • Fever (2 RCT)

        • RR=0.63 (0.46-0.85; p=0.002)


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    Tonsillectomy - Meta-analysis

    • Burkart el al (2005)

      • Assessed 7-RCT

        • 5 used 1-7 days of Amoxicillin

        • 2 used 7 days of Amox/Clav

    • Findings

      • Post-Op Pain (4 studies used VAS):

        • No difference

      • Time to Normal Diet:

        • Reduction in time with Abx: 4.5 vs 3.5 days (p=0.001)

      • Time to Normal Activity

        • Reduction in time with Abx: 7 vs 6 days (p=0.02)


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    Tonsillectomy - Meta-analysis

    • Iyer et al (2006)

      • 4 RCT were included

        • Only included RCT comparing Antibiotic to placebo

    • Findings

      • Not enough studies to calculate quantitative results


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    Tonsillectomy - Meta-analysis

    • Dhiwakar et al. (2006)

      • 5 RCT assessed

    • Findings

      • Fever:

        • RR=0.62 (0.45-0.85) improved in favour of Abx

      • Time to Normal Activity

        • Days= -0.63 (-1.12 to -0.14) in favour of Abx

      • Time to Normal Diet

        • Days=-0.56 (-1.62 to 0.5) with no difference

      • Pain

        • Score: -0.01 (-0.6 to 0.57) with no difference


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    Tonsillectomy - Meta-analysis

    • Concordant Findings

      • Reduced Fever Post-op (2-studies) with Antibiotics

        • Both studies completed by same author

      • Time to Normal Activity (2-studies) with Antibiotics

        • Two Different authors

      • No effect on Pain (2-studies)

    • Discordant Findings

      • Time to normal Diet

    • Antibiotics not used for “Surgical Infections”


    Tonsillectomy and antibiotics l.jpg

    Tonsillectomy and Antibiotics

    • Conclusions

      • Evidence to suggest

        • Reduce time to normal activity by 1 day

        • Reduced fever

      • No evidence

        • Reduce pain

        • Reduce bleeding

      • Does benefit outweigh risk?

        • Not enough evidence to conclude antibiotics do not harm

        • NNH was 26 in Dhiwaker et al (2005)

          • Mainly minor complications


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    Prophylactic Antibiotics

    Septorhinoplasty


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    Nasal Surgery and Antibiotics

    • American Rhinologic Society Survey (2001)

      • Assessed use of antibiotics after septoplasty (n=473)

      • 70% reported using Prophylactic antibiotics

      • Reasons for use:

        • Infection Control – 60%

          • Mainly older surgeons

        • Prevention of Toxic Shock Syndrome – 31.5%

          • Mainly younger surgeons

        • Medical-Legal – 4.9%

        • Odour control – 3.1%

      • Correlation between procedures performed and nasal packing

        • More surgeries performed, less likely to use nasal packing (p=0.001)

        • Those who used nasal packing, more likely to use Antibiotics (p=0.008)


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    Nasal Surgery and Antibiotics

    • Cosmetic Surgeons in USA (2002)

      • 70% of 1767 use antibiotics regularly for septorhinoplasty

        • (Perrottie et al, 2002)

    • Increase in antibiotic use of 200% from 1985 – 2000

      • (Lyle et al, 2001)


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    Toxic Shock Syndrome

    • Syndrome caused by bacterial toxin

      • Staph aureus and Strep pyogenes

    • Pathophysiology

      • Toxin allows non-specific binding of MCH-II resulting in polyclonal T cell activation

        • Cytokine storm results

    • Estimated Incidence in Nasal Surgery

      • 0.2% estimate in post-Fess patients (Abram et al, 1994)

      • 16.5 cases/100,000 cases (Jacobson et al, 1986)

        • True incidence unknown


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    Prophylactic Antibiotics

    • 5-year Prospective study of Septoplasty

      • (Yoder et al, 1992)

      • 1040 patients with no nasal packing

        • No patients received pre/post-op antibiotics

        • 5 patients developed infection (0.48%)

          • 2 maxillary sinusitis, 2-vestibulitis, 1-cellulitis

          • All responded to antibiotics post-infection diagnosis

      • Very low infection risk when no Packing used


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    Randomized Controlled Trials

    • Very few for Septorhinoplasty surgery

      • 3 identified

        • One is extremely poor quality

      • Two of Moderate Quality

        • Andrews et al. (2006) – Single Blind RCT

        • Rajan et al. (2005) – Singe Blind RCT


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    Andrews et al. (2006)

    • 1-day vs 7-day antibiotics in complex Septorhinoplaty

      • Complex: Revision, tip-work, valve insertion

      • 164 Patients

  • Methods

    • Group 1: Amox-Clav - 3-doses

      • At Anaesthesia and then q6h

  • Group 2: Amox-Clav – 7-Day course TID

    • Starting at Anaesthesia induction

  • Blinded evaluator assessed for infection POD#10


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    Andrews et al. (2006) - Results

    • No statistical Difference in infection rates (p=0.42)

      • 1-Day Course: 7%

      • 7-Day Course: 11%

      • Infections:

        • Vestibulitis: 12

        • Septal/Nasal Cellulitis: 3

  • Discussion

    • 1-day course acceptable

    • No adverse effects were reported

    • Packs used, but no mention of duration or type

      • This severely limits application of study results


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    Rajan et al. (2005)

    • Single dose vs 7-day antibiotics in Septorhinoplaty

      • 200 patients

      • 24 hours of Nasal packing and 5-days splints

      • Used Saline Irrigation QID for 14-days

    • Methods

      • Group 1: Amox-Clav 2.2g single IV 30m pre-incision

      • Group 2: Group 1 + Amox-clav 1000mg po BID for 7 days

      • Patients assessed POD#5 and 1-month

        • Surgeons not aware of group however no placebo used


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    Rajan et al. (2005) - Results

    • No significant difference between groups (p=0.26)

      • Single Dose: 0% with infection

      • 7-day Course: 3% with infection

      • Complications/Side Effects

        • More common in 7-day group

          • 29% vs 2% (p=0.03)

          • Nausea, diarrhea, skin rash, pruritus

    • Discussion

      • Single dose effective with low side-effects

      • Would infection rate change without irrigation?

      • No definition of infection identified


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    Study Comparison

    • Surgery Type

      • Complex vs routine Septorhinoplasty

        • No tip-work, revisions in Rajan Study

      • Evidence that complex Septorhinoplasty (Prisig and Schafer, 1998)

        • Increases infectious agents from 5.5% to 24%

        • Increased risk of post-op infection near 27% if untreated

    • Nasal Packing

      • Only Rajan study indicated specifics of nasal packing

    • Dosing of Antibiotic

      • Rajan used Higher Dose for 1 Injection

        • [2.2g IV x 1] vs[1.2g IV Q6h x 3]

      • 7-day course

        • Rajan: 1000mg PO BID vs Andres: 375mg PO TID

    • Assessment of Infections

      • Rajan: No indication as to how infections were evaluated or defined

      • Andrews: Specific definition of infections, used validated assessment measures


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    Cephalosporins and Nasal Surgery?

    • Only one study assessed Cefazolin

      • RCT with 35 subjects and three treatment groups (Caniello et al. 2005)

        • Low Power

        • “Anterior nasal packing used in some cases”

      • Group 1: No antibiotics

      • Group 2: Cefazolin 1g IV at induction

      • Group 3: Group 2 + 500mg PO QiD for 7 days

    • Results

      • No difference in infections, complications

        • Purulence was definition of infection

        • Authors graded degree of purulence

    • Conclusions

      • Very poor study

      • Should not have been published


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    Antibiotics in Septorhinoplasty - Conclusions

    • Severe complications very rare

      • No reports in any reviewed studies

      • Case reports available

    • Minor complications rare if no Nasal Packing

      • Antibiotics likely not necessary in routine surgery with no nasal packing

    • Short Course antibiotics equal to extended course

      • Amox-Clav

      • Evidence weak given paucity of studies

    • No evidence for 1st Generation Cephlosporins


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    Antibiotic Prophylaxis

    Otology Surgery


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    Studies Assessed

    • Meta-analysis

      • Verschuur et al. (2004) - Clean and clean-contaminated ear surgeries

    • RCT

      • Kocarurk et al (2005) – Ventilation Tube Insertion

      • Govaerts et al. (1998) – Multiple Procedures

    • Prospective Cross-Sectional Study

      • Kumar et al. (2005) – Ventilation Tube Insertion

    • Retrospective Studies

      • Golz et al. (1998) – Ventilation Tube Insertion


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    Verschuur et al. (2004)

    • Assessed efficacy of prophylactic antibiotics

      • Meta-analysis

    • Clean Surgeries

      • Tympanoplasties, stapedotomy, stapedectomy

      • Facial Nerve Decompression

      • Canal-Wall Up with no Middle Ear Infection

    • Clean-Contaminated

      • Surgery with Infected Middle Ear

      • Any surgery with Chronic Otitis Media


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    Results

    • 6-studies identified meeting Inclusion Criteria

    • Findings (OR, fixed-effect)

      • No significant effects of Prophylactic antibiotics for:

        • Post-Op infections within 3-weeks

          • 6 Studies with 1291 Patients: OR=0.73 (0.45-1.2)

        • Graft Failure at 3-weeks Post-op

          • 2 Studies with 2282 patients: OR=0.71 (0.35-1.45)

      • No significant effects of post-op antibiotics for:

        • Post-op infections within 3-weeks

          • 3-studies with 229 patients: OR=1.02 (0.49-5.07)

        • Graft Failure within 3-weeks

          • 31-study with 146 patients: OR=0.21 (0.01-4.36)

      • Adverse Drug Effects

        • 2 Studies with 841 patients

          • OR=7.3 (0.2 – 2.64)


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    Govaerts et al. 1998

    • Placebo-controlled, Double Blind RCT

      • 750 Patients

    • Assessed efficacy of Cefuroxime in Ear Surgery

      • Neuro-otology or cochlear implant surgery patients excluded

  • Two groups:

    • Cefuroxime 1.5g IV at induction and 6h later

    • Placebo (anesthesia was blinded)

  • Postoperative infection defined by one of:

    • fever

    • wound inflammation

    • wound secretion

    • Myringitis

    • otitis media.


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    Results

    • Overall infection Rate of 3.9%

      • No difference between groups

        • 4.7% in Placebo

        • 3.1% in Cefuroxime

    • Longer operating times associated with more infections (p<0.0001)

      • 3.4h vs 2.1h for infected vs non-infected ears

      • Did not stratify groups to determine if antibiotics were more useful in longer surgeries

    • No infections in otosclerosis surgery

    • 100% of infections occurred in tympanoplasties

      • Highest rate when using (both p<0.0001):

        • tympanoossicularallografts

        • fascia graft in underlay

      • No infections in dry-perforation pre-op


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    Early vs Late Infection

    • Cefuroxime results in significantly fewer infections in 1-week post-op (p<0.05)


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    Study Analysis

    • More infections occurred within 1-week in placebo group

    • More infections occurred between week 1 and 2 in Cefuroxime group

      • Does Cefuroxime select for more virulent strains?

    • Severe infections resulting in graft necrosis

      • 1 in Placebo

      • 2 in Cefuroxime group

    • Sample size to small to determine if there is relationship


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    Study Analysis

    • Clean surgeries do not require antibiotics

      • Clean perforations or otosclerosis

    • Cefuroxime protects against early 1-week infections

      • But offer no “overall” protection

      • Authors did not comment on this discrepancy


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    Kocaturk et al (2005)

    • 280 Pediatric patients with serous otitis media

      • Receiving VT insertion

      • Randomly assigned to one of 4 groups

        • Control – VT tube insertion only

        • Isotonic Saline – 1ml syringe used to irrigate middle ear

        • Oral Abx – Sulbac-Amp 25mg/kg for 5 days

        • Topical Abx – Ofloxacin otic drops BID for 5 days


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    Results

    • Post-op Purulent Otorrhea in 48 patients

      • Treatments significantly better than control (p=0.005)

    • Control: 30%

    • Saline: 15.7%

    • Oral Abx: 14.28%

    • Drops: 8.57%

  • No significant difference between treatment groups

  • Cost savings – Cost per successfully treated patient

    • Saline: 0.18 USD

    • Oral Abx: 10.50 USD

    • Drops: 1.65 USD


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    Conclusion

    • Saline appears as effective as antibiotics

      • Significantly less expensive

      • Did not consider cost of treating additional post-op infections in cost calculation

    • Low sample size to conclude Otic Drops Not significantly better than saline

      • Significantly less expensive than oral abx

    • Otic Drops may be ideal given sample size


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    Kumar et al (2005)

    • 488 pediatric patients

      • Received either cipro drops or oxymetazoline drops post-op

        • No randomization, no comment on who or how patient was chosen for group

        • No comment on dose, frequency or duration of drops

    • Results

      • Overall post-op Otorrhea was 8.9%

        • No difference between drops

      • Authors suggest oxymetazoline equivalent to cipro drops

  • Conclusions

    • Insufficient evidence to conclude findings proposed in study

    • Poorly interpreted study

    • Did not distinguish between clear and purulent otorrhea post-op


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    Otology - Recommendations

    • Insufficient evidence to make recommendations

      • Little evidence to recommend antibiotics

      • Topical drops appear as effective as systemic drops

        • Cipro

      • Cefuroxime may not be appropriate prophylaxis in otology surgery

    • More research required


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    Antibiotic Prophylaxis

    Conclusions


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    Final Conclusions

    • Infectious complications are rare in majority of ENT procedures

      • Clean-Contaminated head and neck procedures are exception

    • Prophylactic antibiotics are recommended for Clean-Contaminated Head and Neck Procedures

      • Short term <24h are efficacious

    • There are numerous studies within each sub-specialty of ENT

      • However, answers remain elusive


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    The End

    Any Questions?


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    Risk Factors in Head and Neck

    • Prospective study of 258 (Lotfi et al, 2008)

      • Head and Neck Malignant Neoplasms

      • Antibiotics administered to all patients (24-48h)

        • No consistent antibiotic regimen (3 regimens in total)

        • Significant p<0.05

    • Univariate Positive Risk Factors

      • Smoking: OR=2.96 (p=0.04)

      • Positive Node(s): OR=2.05 (p=0.01)

      • Free flap required: OR=2.2 (p=0.01)

      • Antibiotics >48h: OR=1.89 (p=0.03)

        • Confounding as one would expect prolonged antibiotics if infection present

  • Discussion

    • Vague Definition of “SSI”

      • No mention of when infection started

    • True Significance would be p<0.0125


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