2. ANTIBIOTICS FOR SURGICAL PROPHYLAXIS
Surgical antibiotic prophylaxis is defined as the use of antibiotics to prevent infections at
the surgical site.
The use of peri-operative antimicrobials has become an essential component of the
standard of care for certain surgical procedures and can result in a reduced risk of
post-operative infection when sound and appropriate principles are utilized.
However, the benefit of antimicrobial prophylaxis must be weighed against the risks
of toxic and allergic reactions, emergence of resistant bacteria, drug interactions,
super-infection, and cost.
A single dose of antibiotic is usually sufficient if the duration of surgery is four hours
or less.
The prophylactic agent must be administered in a dose which provides an effective
tissue concentration prior to incision / intra-operative bacterial contamination.
3. In most instances, a single intravenous dose of an antimicrobial agent
provides adequate tissue concentrations around the time of anesthesia
induction and throughout the operation.
1. Antimicrobial agent infusion should begin 15-60 minutes before the
incision with the exception of vancomycin, levofloxacin, ciprofloxacin,
gentamicin, azithromycin and fluconazole. These infusions should begin
45-90 minutes before the incision.
2. In adult patients, cefazolin (2 g if <120 kg, 3 g if ≥120 kg) and
vancomycin (1 g if <80 kg, 1.5 g if ≥80 kg) dosing is based on weight. Adult
patients <50 kg should refer to Patients <50 kg (Adult and Pediatric) Dosing
recommendations for dosing. Weight-based dosing is recommended for all
antibiotics in patients <50 kg.
4. Many antimicrobials require a single dose given within 60 minutes of skin
incision to provide adequate tissue concentration throughout the operation.
Additional doses during the procedure are advisable if surgery is prolonged
(ie, > 4 h), major blood loss occurs, or an antimicrobial with a short half-life
is used.
The antibiotics should be discontinued 24 hours after surgery, as the
prolonged use of prophylaxis leads to bacterial resistance and increased
hospital costs.
The immunocompetency of the patient should also be evaluated, which
includes attentiveness to factors such as history of previous surgery creating
scarring, radiation exposure, malnourishment, or HIV infection, among
others. However, a diagnosis of diabetes mellitus remains controversial in
assessing complication risk specific to head and neck surgery.
5. All prophylactic antimicrobials should be discontinued after the intra-
operative period, unless otherwise specified.
a. Data have not supported subsequent doses after surgical closure
and may increase the risk of Clostridium difficile and antimicrobial
resistance.
b. A longer duration of antimicrobials may be indicated, if concomitant
infection is present at the time of surgery.
Redosing in Patients with Excessive Blood Loss: Most antibiotics should
be redosed in patients who have lost over 1500 mL of blood.
6. Antibiotics are used in addition to appropriate treatment to aid the
host defenses' in the elimination of remaining bacteria. It is indicated
when there is evidence of clinical sign involvement and spread of
infection.
Antibiotics are prescribed in dental practice for treating odontogenic
infections, non-odontogenic infections, as prophylaxis against focal and
local infection.
Special care needs to be addressed to patients with organ transplants,
poorly controlled diabetes and pregnancy. Antibiotics should be used
only as an adjunct to dental treatment and never alone as the first line
of care.
7. SURGICAL SITE INFECTION
Surgical site infection (SSI) is defined as an infection that occurs after a surgical incision
or organ manipulation during surgery.
SSI is an infection that develops within 30 days after an operation or within 1 year of an
implant being placed, where the infection appears to be related to the surgery.
The frequency of SSI reported for clean head and neck surgical procedures without
antimicrobial prophylaxis is <1%.
In contrast, infection rates in patients undergoing complicated cancer surgery are high,
ranging from 24% to 87% of patients without antimicrobial prophylaxis.
for patients with renal or hepatic dysfunction, antimicrobial prophylaxis often does not
need to be modified for these patients when given as a single preoperative dose before
surgical incision.
Almost 80 million surgical procedures are annually performed in the United States. SSI
affects approximately 1.9% of surgical procedures .
8. CLASSIFICATION OF SURGICAL OPERATIONS
Surgical operations can be classified into two groups, according to the
presence or absence or microorganisms in the surgical area.
Some examples in maxillofacial surgery are:
Surgical operations with absence of microorganisms: impacted
teeth, exostosis, torus, odontogenic tumors, cysts (not infected),
epulis, periprosthetic and preorthodontic surgery, closed maxillary
fractures, salivary glands diseases, osteotomies, grafts, flaps…
Surgical operations with presence of microorganisms: third molar
pericoronitis, inflammatory cysts, teeth roots, granulomas,
sialolithiasis, open fractures, traumatisms, contusions, infection inside
a tumor, radionecrosis, etc.
9.
10. THE AMERICAN SOCIETY OF HEALTH-SYSTEM PHARMACISTS
(ASHP) CATEGORIZES SURGERY IN FOUR DIFFERENT CLASSES
clean (e.g., atraumatic procedures or where neither the gastrointestinal,
genitourinary, nor respiratory tracts is violated such as cervical lymph node
excisions)
clean-contaminated (e.g., procedures that violate the gastrointestinal or
respiratory tract such as parotidectomy, submandibular gland excision, third molar
removal)
contaminated (e.g., surgery in acute inflammation situation such as open mandible
fracture repair with osteosynthesis)
dirty (e.g., procedures involving pus or compound/open injuries such as dentogenic
abscess incision)
11. Classification of surgical wounds according to the risk of
contamination-infection
Type I: clean wounds (no disruption of mucosa such as the oral cavity): infection rate 1-4%.
No prophylaxis or prophylaxis no longer than 24 hours with amoxicillin-clavulanate as there is
no benefit in using postoperative antibiotics.
Type II: clean-contaminated wounds (disruption of mucosa such as the opening of mucosa in
the oral cavity, insertion of dental implants, or surgery in an inflamed area): infection rate 5-15%.
Prophylaxis against gram + and anaerobic bacteria
Type III: contaminated wounds (oncological surgery in which both oral cavity and neck
contact): rate infection 16-25%. Prophylaxis against gram +, anaerobic bacteria and also gram
–, which are not covered in clean and clean contaminated surgeries.
Type IV: dirty and infected wounds. infection rate of above 26%. These always need adequate
antibiotic treatment, not prophylaxis. The use of antiseptics in the oral cavity reduces the amount
of the bacteria in the surgical area, but has not demonstrated to be effective in the prophylaxis
of the bacterial colonization.
12. CHOICE OF ANTIBIOTICS AND SPECTRUM
Choosing an antibiotic for prophylaxis is multifactorial and
should be based on the following:
• Type of operation.
• Kinetics and toxicity of the drugs.
• Microbiologic characteristics of the operative site.
• Antibiotic sensitivities specific to the particular hospital
environment.
13. If a number of drugs appear equally acceptable for prophylaxis, the
agent least likely to be used for definitive therapy in postoperative
wound infection should be chosen. This strategy should minimize the
selection of organisms resistant to valuable therapeutic agents. Recent
studies have shown that high dose parenteral first generation
cephalosporins have equal efficacy as third generation options in
patients undergoing a procedure in clean-contaminated oncologic
surgery. This could allow for the opportunity to continue to use first
generation cephalosporins while preserving resistance rates in the third
generation class. Therefore, the need to assess susceptibility profiles
while selecting antibiotics is emphasized.
14. HIGH RISK PATIENTS
Risk factors for surgical site infections in head and neck surgery include
cancer at advanced stages, smoking, comorbidities, major reconstruction of
the surgical wound, tracheotomy procedure, malnourished patients, or those
who were submitted to inadequate antibiotic prophylaxis. Furthermore,
increased duration of prophylaxis has failed to decrease infection in many of
these high risk groups.
The issue of diabetic prophylactic efficacy remains controversial, as studies
have failed to show a correlation between diabetes and increased surgical site
infection post head and neck surgery. However, postoperative complications in
free tissue transfer flaps have increased in diabetic patients, at a rate
equivocal to patients treated with immunosuppressive drugs. The majority of
these diabetic patients had concomitant peripheral vascular disease, allowing
us to appreciate the impact that short and long-term glycemic control have on
post surgical morbidity. The reported increases in diabetic complications have
been attributed to decreased innate and acquired immunity and even renal
failure with uremia-induced immunosuppression. Regardless, the topic of
diabetic head and neck surgical outcomes, opposed to well documented
15. FACIAL FRACTURES
Open fractures have an increased incidence of infection in the
absence of antibiotic prophylaxis when compared to closed
or open fractures treated with prophylactic antibiotics.
The infection rates of mandible fractures treated with closed
or open reduction are similar, provided that antibiotics are
used in the perioperative period.
Studies have concluded that antibiotic prophylaxis
significantly reduce the incidence of postoperative infections
in facial fractures, especially mandible fractures of the body
or parasymphyseal region.
The infection rates in zygoma fractures, LeFort fractures,
and mandibular subcondylar fractures are similar.
16. 1- Patients with impaired renal function need individualized initial and secondary
antibiotic dosing based on GFR and case type
2- For antimicrobials with a short half-life (e.g., cefazolin, cefoxitin) used before long
procedures , re -dosing in the operating room is recommended at an interval of
approximately two times the half -life of the agent in patients with normal renal
function . Recommended re-dosing intervals marked as “not applicable” (NA) are based
on typical case length; for unusually long procedures , re -dosing may be needed.
3- While fluoroquinolones have been associated with an increased risk of tendinitis
/tendon rupture in all ages , use of these agents for single-dose prophylaxis is generally
safe.
4- Vancomycin prophylaxis should be considered for patients with known MRSA
colonization or at high risk for MRSA colonization in the absence of surveillance data
(e.g., patients with recent hospitalization, nursing home residents , hemodialysis
patients). ASHP guidelines.
17.
18.
19. NATURE OF OPERATION No Penicillin Allergy
Option in
penicillin/cephalosporin
allergy
No incision through mucosal (oral,
nasal, pharyngeal, esophageal)
surface
Cefazolin 2g IV (child: 30 mg/kg up to 2 g)
High risk of MRSA: ADD vancomycin 1 g IV
infusion (1,5 g for patients >80 kg actual
body Weight)
Clindamycin 600 mg IV
infusion (child:15 mg/kg up to
600 mg
High risk of MRSA: Add
vancomycin 1 g IV infusion
(1.5 g for patients >80 kg
actual body weight)
15 to 30 minutes before
surgical incision
With incision through mucosal
(oral, nasal, pharyngeal,
esophageal) surface
Cefazolin 2g IV (child: 30 mg/kg up to 2 g)
+Metronidazole
500 mg IV infusion (child: 12.5 mg/kg up to
500 mg)
High risk of MRSA: ADD vancomycin 1 g IV
infusion (1.5 g for patients >80 kg actual
body Weight)
15 to 30 minutes before surgical incision
Uncontaminated neck dissection: Prophylaxis NOT recommended
(South Australian expert Advisory Group on Antimicrobial Resistance in 2017
20. NATURE OF OPERATION No Penicillin Allergy
Option in
penicillin/cephalosporin
allergy
Thyroidectomy—para thyroidectomy Prophylaxis NOT required
Clean-contaminated surgery
involving head and
neck cancers (breach in oral cavity,
elderly patient, complex or previous
surgery
Cefazolin 2 g and metronidazole 500 mg
Gentamicin (1.5 to 3 mg/kg)
Just one dose (max: 240 mg
Or vancomycin
Contaminated/dirty/complex
surgery:
Cefazolin 2 g and metronidazole 500 mg
MRSA colonized/infected
add vancomycin 15 mg/kg (ABW) (Max 2.5
g) or clindamycin 600 mg to regimen
ADHB (Auckland District Health Board) 2015 New Zealand
21. SADI (Sociedad Argentina de Infectología 2017
Recommended prophylaxis penicillin/cephalosporin allergy
32. China (Chinese Society of Surgery) 2006
Recommended prophylaxis penicillin/cephalosporin allergy
33. SURGICAL QUALITY AND PATIENT PREPARATION
Antibiotic prophylaxis cannot compensate incorrect surgical safety protocols. Hand
scrub, correct handling of the surgical site, strict application of asepsis measures, a
clean environment in the operating room and decontamination of medical devices
and surgical instrument, careful management of surgical instruments during
surgery, as well as a proper surgical technique to minimize the duration of surgery
are all important.
From the patient's perspective, a shower before surgery using either normal or
antimicrobial soap may be beneficial.
Shaving hair is strongly discouraged, either preoperatively or in the operating
room. If absolutely necessary, hair should be removed only with clippers.
34. HABITS AND PATIENTS' COMORBIDITIES
Habits like smoking, tobacco or alcohol abuse, hypothyroidism, exposed hardware
(eg, plates and screws), and methicillin-resistant Staphylococcus aureus
colonization are known factors that can affect wound healing and represent a risk
factor for SSI in H&N surgical oncology. Diabetes is also a well-known risk factor for
SSI in the surgical literature. However, the role of diabetes in H&N oncologic
surgery SSI is controversial.
Glycemic control:
Optimal glycemic control is important to avoid SSI by implementing perioperative
glycemic control and using blood glucose target levels <200 mg/dL in patients with
and without diabetes.
36. OPTIMAL TIMING OF PREOPERATIVE ANTIBIOTIC ADMINISTRATION
AND CORRECT ANTIBIOTIC DOSE
Preoperative antibiotics need to be given within 60 min before the surgical incision,
so that a bactericidal concentration of the antibiotics is present in the serum and
tissues when the incision is made. Some agents such as fluoroquinolones and
vancomycin require administration over 1 to 2 h; therefore, the administration of
these agents should begin within 120 min before surgical incision.
Redosing is required to ensure adequate serum and tissue antimicrobial
concentrations, if the duration of the procedure exceeds two half-lives of the drug
or if excessive blood loss is observed.
Obesity has been linked to an increased risk for SSI.
The pharmacokinetics of drugs may be altered in obese patients, so dosage
adjustments based on body weight may be warranted in these patients.
37. DURATION OF PROPHYLAXIS
Prophylactic antimicrobials use involves a single dose or
eventual continuation for less than 24 h postoperatively. In a
recent meta analysis of 340 patients in four randomized
clinical trials (RCT), the authors found no difference in the risk
of SSI between patients randomized to 1 day vs 5 days of
systemic antibiotic therapy.
A previous RCT including 60 patients also showed that
extended courses of antibiotics (<7 days) are not superior to a
24-h postoperative course in clean neck dissection.
38. WHICH IS THE BEST ANTIBIOTIC FOR HEAD AND NECK PROPHYLAXIS?
There are insufficient data to compare different antibiotic regimens.
Yet, several retrospective studies suggest that clindamycin may be
inferior to other antibiotic regimens. A recent large retrospective
database study of over 8,800 patients showed that among patients
receiving ampicillin/sulbactam, clindamycin, cefazolin/metronidazole,
cefazolin only, or no prophylactic antibiotics, for either the day of
surgery only or for 1 day after surgery, the group at highest risk were
those receiving clindamycin through postoperative 1 day.
39. IS ANTIBIOTIC PROPHYLAXIS REQUIRED FOR H&N SURGERY WITH
FREE FLAP RECONSTRUCTION?
Evidence consistently supports the use of antibiotics when free flap microvascular
reconstruction is performed. Osteocutaneous flaps are more prone to develop wound
infection compared with soft tissue-only flaps.
Other factors related to free flap microvascular reconstruction and associated with SSI
include duration of surgery, operative blood loss, postoperative flap failure, return to the
operating room, and need for microsurgical revision.
Amoxicillin/sulbactam has been found to be superior to cefuroxime and other penicillin's
when a free flap is done.
Different groups of researchers have attempted to define the optimal type and duration of
antibiotics without finding a perfect duration. Studies have not found any benefit from
prolonged duration of antibiotics in reducing postsurgical infections. However, these studies
have compared either 1- or 2-day regimens to longer durations, and it remains unclear if a 2-
day period of treatment is superior to a 1-day course. As such, some have advocated 48-h
postoperative antibiotic prophylaxis for free flap cases.
40.
41. DO PREVIOUS SURGERY OR PREVIOUS RADIATION THERAPY
INCREASE THE RISK OF SSI IN H&N SURGERY?
Several studies show an association between previous radiotherapy
and increased risk of SSI, being worse in patients exposed to irradiation
doses greater than 60 Gy.
Suh et al found an association between previous surgery and the risk of
developing SSI. Despite the available evidence that shows an increased
risk for infection, there is no enough scientific evidence in regard to
antibiotic prophylaxis in these cases, neither to support or to refuse.
42. WHAT ALTERNATIVE OPTIONS ARE THERE FOR PATIENTS WITH TRUE
Β-LACTAM ALLERGIES?
Antimicrobial prophylaxis guidelines for H&N surgery recommend prophylaxis with
clindamycin as monotherapy as an alternative agent for patients with trueβ-lactam
allergies, but it is important to consider the significant difference in the spectrum
of activity between the first- and second-line recommendations. Moreover, recent
data suggest that clindamycin use is associated with an increased risk of SSI.
Prophylaxis with clindamycin monotherapy in patients with trueβ-lactam allergies
should therefore be avoided.
Other options can be the combination with gentamycin or tobramycin, the use of
clarithromycin + metronidazole or vancomycin alone, or in combination with
teicoplanin. However, more data about this second-line option is necessary.
43. CEFAZOLIN + METRONIDAZOLE OR AMINOPENICILLIN +
BETALACTAMIC INHIBITOR?
The two most common recommended antibiotic prophylaxis protocols
among different guidelines was cefazolin + metronidazole or
aminopenicillin + betalactamic inhibitor. Cefazolin is useful against
gram-positive and gram-negative bacteria, and metronidazole is useful
against anaerobic bacteria. On the other hand, aminopenicillin is useful
against aerobic, gram-positive, and some gram-negative bacteria, while
the combination with a betalactamic inhibitor improve the spectrum
covering gram positive, gram-negative aerobic and anaerobic bacteria.
46. RATIONALE FOR AP IN DENTISTRY
The term antibiotic prophylaxis indicates the administration of antibiotics before surgical
and non-surgical procedures with the aim of preventing local and systemic bacterial
infective complications. The oral cavity is one of the most contaminated regions of the
human body, with a microflora including over 700 different microbial species, with about
100 of them able to grow in culture and to infect distant sites.
in order to optimize the risks/benefits ratio of AP, the antimicrobial agent should be:
1. Given only in conjunction with a dental procedure with a significant risk of infection.
2. Administered in appropriate dosage and timing to ensure adequate concentration at the
incision/wound site during the period of potential contamination.
3. Prescribed for a period as short as possible in order to minimize adverse effects (i.e.
hypersensitivity, toxicity, superinfection, development of microbial resistance and public
health costs).
47. DISADVANTAGES OF ANTIBIOTICS
The use of antibiotics may encourage laxity of good surgical
technique. It promotes antibiotic resistance and contributes to
superinfection. Antibiotic use is also costly and associated with
allergic reactions, toxic reactions, and adverse effects. Studies
have shown increased hospital stay and morbidity with extended
oral prophylaxis; which could be attributed to adverse side effects
of the antibiotic regimen or opportunistic infection such
as Clostridium Difficile.
Dental procedures can cause a transient bacteremia of various degrees, with
higher values in oral surgery (third molar extraction, periodontal surgery)
However, bacteremia also occurs in conjunction with several daily activities,
such as tooth brushing and chewing and it has been estimated that the
cumulative bacteremia induced by routine activities is about six million
times higher than bacteremia occurring after a dental extraction.
48. The majority of oral surgical procedures result in clean-contaminated wounds, characterized by
the spread of Gram-negative organisms. Nevertheless, the need for AP is still debated For example,
post-operative infections reported after third molar surgery are infrequent, with incidence rates
ranging from 1% to 11.8% In addition, they are usually circumscribed, auto-limiting and easily
curable by means of drainage and anti-inflammatory/antibiotic therapy.
Similar findings have been obtained also for dental implant placement. A recent review of the
literature conducted by Cochrane reviewers concluded that there is no evidence recommending or
discouraging the use of AP to reduce dental implant complications and failures, due to the
absence of controlled randomized clinical trials Most of authors agree that reduction of
postoperative complications is mostly correlated to improvement in surgical technique and major
control of intra-operating contamination rather than AP administration.
Taking into account the reported findings, there is a very low level of recommendation around the
routine use of AP in oral surgery performed on healthy patients for local infection prevention.
AP AND PREVENTION OF LOCAL INFECTIONS
49. In the presence of further systemic diseases, administration of AP should
be considered based on a careful evaluation of risks and benefits, after a
multi-specialist consultation (i.e. general practitioner, cardiologist,
nephrologist, diabetologist, immunologist, orthopaedist, neurologist).
Conversely, no evidence supports the prescription of AP in healthy
individuals; in the same way, prophylactic administration of antibiotics
immediately after oral surgery or even in the succeeding days is not sustained
by any scientific evidence and it has to be absolutely avoided.
50. Bacterial contamination during implant placement is thought to be
responsible for early implant losses and infected dental implants are
difficult to treat, and 2% eventually will be removed.
Prophylactic antibiotic treatment is the use of antibiotics before,
during or after therapeutic, diagnostic or surgical procedures with the
aim of preventing infectious complications. This differs to therapeutic
antibiotic treatment which aims to clear infection caused by a
colonizing micro-organism.
According to the World Health Organization (WHO), antibiotics are the
most misused of all medicines due to ease of access, being inexpensive,
familiar and with generally good safety profiles. This has led to the
growing problem of antimicrobial resistance (AMR) which is becoming
a global threat that could cause an eventual loss of antibiotic efficacy.
51. Antibiotics are however appropriate for oral infections where there is
evidence of spreading infection (swelling, lymph node involvement and
cellulitis) or systemic involvement such as malaise and fever according
to the Scottish Dental Clinical Effectiveness Programme.
No statistically significant evidence was found to support the routine
use of prophylactic antibiotics in reducing the risk of implant failure or
post-operative complications under normal conditions.
Prophylactic antibiotics probably reduce the risk of implant failure by
57% based on 711 patients under normal conditions.
There is also little conclusive evidence favouring the routine use of
prophylactic antibiotics for third molar extractive surgery requiring
bone removal in healthy young adults.