Showing posts with label azithromycin. Show all posts
Showing posts with label azithromycin. Show all posts

Thursday, May 4, 2017

CDC releases ‘long awaited’ guidelines for preventing surgical site infections.

courtesy: cpsi

The Center for Disease Control released it’s much awaited update to its 1999 guidelines for the prevention of surgical site infections (SSIs). The guidelines were published online May 3, 2017 in JAMA.

As the number of surgeries performed worldwide rise, so does the human and financial cost of treating this infection also rises as reimbursements for SSIs are often reduced or denied. It is estimated that 50% of SSIs are preventable.

A targeted systematic review of the literature conducted from 1998 through April 2014 identified nearly 5750 studies and abstracts, out of which 896 underwent detailed review by 2 independent reviewers. After review, about 170 studies were finally used to construe the final guidelines.

Each recommendation was graded based on the standard GRADE approach (Grading of Recommendations, Assessment, Development, and Evaluation) as strong 1A to no recommendation depending on strength of evidence for benefit and harm to the patient.

The recommendations are:

In elective surgeries, the patients should take a shower or full body bath with antimicrobial or nonantimicrobial soap, antiseptic agent not earlier than night before the day of surgery. (Category IB)

Preoperative antimicrobial agents should only be administered when indicated according to clinical practice guidelines, at such time that the bactericidal levels of agent is achieved at the time of tissue incision. No specific timing recommendation is possible at this stage because of insufficient evidence at present.

In cesarean section, parenteral prophylactic antimicrobial agent is indicated before the skin incision is given. (Category IA–strong recommendation; high-quality evidence.)

At this time no recommendation is made for weight-adjusted parenteral antimicrobial prophylaxis dosing or redosing of parenteral antibiotics during the surgical procedure.  

Skin preparation should be done with alcohol based antiseptic agents. (Category IA–strong recommendation; high to moderate–quality evidence.)

No recommendation is made for intraoperative antimicrobial irrigation (eg, intra-abdominal, deep, or subcutaneous tissues) for the prevention of SSIs.

A recommendation is made for NOT to apply any antimicrobial cream, ointment or powder to the surgical incision. (Category IB–strong recommendation; low-quality evidence.)

Applying antimicrobial dressings after primary closure is also not recommended because of lack of strong evidence.

All patients who are diabetic or non-diabetic should have blood glucose levels less than 200 mg/dL during and after surgery. (Category IA–strong recommendation; high to moderate–quality evidence.)

Evidence also suggest for maintaining perioperative normothermia to reduce the risk of SSIs. (Category IA–strong recommendation; high to moderate–quality evidence.)

Patients undergoing surgery under general anesthesia, should be given high fraction oxygen during surgery and after extubation in the immediate postoperative period.

Evidence does not favor the application of microbial sealant or plastic adhesive drapes with or without antimicrobial properties after intraoperative skin preparation.


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.)

Insufficient evidence also exist about repeat application of antiseptic agents to the patient’s skin immediately before closing the surgical incision.

The recommendation also advise to not to withhold giving of necessary blood products from surgical patients as a means to prevent SSIs.

The recommendations provided a total of 42 statement, with 8 category 1A, 4 category 1B, 5 category II and 25 issues for which no recommendation was made because of insufficient evidence of benefit or harm.

The authors agree that “The number of unresolved issues in this guideline reveals substantial gaps that warrant future research. Nonetheless, the thoroughness and transparency achieved using a systematic review and the GRADE approach to address clinical questions of interest to stakeholders are critical to the validity of the clinical recommendations.”

"Adequately powered, well-designed studies that assess the effect of specific interventions on the incidence of SSIs are needed to address these evidence gaps," they further add.

An invited commentary by Pamela A. Lipsett, MD, MHPE, MCCM, from the Department of Surgery, Anesthesiology, and Critical Care Medicine at the Johns Hopkins University School of Medicine, Baltimore, Maryland, and section editor of JAMA Surgery was also published in the journal.

Dr Lipsett opined that 25 unresolved issues, specifically in areas of orthopedics and joint replacement surgery shows that we need to focus more on clinical trials.

She also said that "There is a lot of opportunity to learn how we can provide more effective care to our patients."

She further added that the guidelines are useful for telling surgeons "what we should do and what we do not know."

The full text of the article in JAMA can be accessed here.
The commentary in JAMA can be accessed here.

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Monday, February 13, 2017

Maternal clinical risk factors for increased rate of post cesarean infection identified.

Pixabay.com

Preincisional extended antibiotic prophylaxis does not prevent occurrence of maternal infections that significantly contributes to increased maternal morbidity in cesarean sections.

Maternal BMI, rupture of membranes to delivery interval, race and duration of surgery are important contributing factors towards maternal infection even after prophylactic antibiotics were given according to a study published online ahead of print in Journal of obstetrics and gynecology.

This was a secondary analysis Cesarean Section Optimal Antibiotic Prophylaxis trial (C/SOAP),that concluded that pairing Azithromycin with standard pre-incisional prophylaxis reduced the surgical site infection by nearly 50%.  Dr. Alan Tita presented the paper  at the 36th Annual Pregnancy Meeting 2016 sponsored by the Society for Maternal-Fetal Medicine.

The secondary analysis of the data was done in an effort to further identify maternal clinical risk factors that can further reduce the risk of maternal infections.

The primary outcome studied was maternal infection and consists of  a composite of endometritis, wound infection (superficial or deep), or other infections occurring up to 6 weeks postpartum.
Data from all 2013 patients in the primary study was included in the secondary analysis.

After controlling for Azithromycin: maternal age, duration of ROM, duration of surgery, vertical or non-transverse skin incision, staple skin closure, BMI and labor induction significantly influenced the incidence of maternal morbidity.

After parsimonious regression model, in which those variables that were statistically non-significant were removed from the analysis, showed that black race, duration of rupture of membranes more than 6 hours and duration of surgery more than 49 minutes were significantly associated with increased maternal infection.

If duration of rupture of membrane exceeds 6 hours than the rate of maternal infection increases by 1.9 to 3.4-fold.

In addition, in unadjusted analysis patients with BMI more than 30 had 2.5 times higher risk of infection as compared to those with BMI< 25 in whom the risk of infection  was minimal.

The researchers advocate need of additional studies in patients with these risk factors to formulate guidelines for further reduction in infectious morbidity.


Tuesday, June 7, 2016

Preincisional Azithromycin cuts postcesarean maternal infection by half.

The CesareanSection Optimal Antibiotic Prophylaxis (C/SOAP) study is a large pragmatic multi-center randomized clinical trial designed to evaluate the comparative effectiveness and safety of azithromycin-based extended-spectrum antibiotic prophylaxis (azithromycin plus standard narrow-spectrum cephalosporin) relative to standard single-agent cephalosporin (preferably prior to surgical incision) to prevent post-cesarean infection.

Paired with standard prophylactic antibiotics, broad-spectrum intravenous azithromycin was highly effective, with a number needed to treat of 17 to prevent one postsurgical infection, and 43 to prevent one case of endometritis, Dr. Alan Tita reported at the 36th annual Pregnancy Meeting sponsored by the Society for Maternal-Fetal Medicine.

“We also saw fewer maternal adverse events, and the protocol was safe for the newborn,” said Dr. Tita, who is a professor of obstetrics and gynecology at the University of Alabama, Birmingham.
This trial enrolled 2,013 women at 14 sites, who had singleton pregnancy of at-least 24 weeks, not scheduled for elective LSCS and underwent surgery after being in active labor for at-least 4 hours or 4 hours after rupture of membranes.

All women received standard preoperative antibiotic prophylaxis with either cefazolin or clindamycin. The women were than randomized to receiving either preincisional intravenous azithromycin 500 mg or a placebo.

As the study was multicentric, skin preparation was done according to standard protocols at each center.

The primary outcome measures were composite of endometritis and/or wound infection and/or other post-cesarean infections (occurring within 6 weeks of delivery) and the secondary outcomes were individual post-cesarean infections: Endometritis, wound infection (including necrotizing fascitis), other infections including abscess, septic thrombosis, pneumonia, pyelonephritis and breast infection.

The neonatal outcome was a composite of death; primary or suspected sepsis; and serious neonatal morbidities, including respiratory distress syndrome, necrotizing enterocolitis, periventricular leukomalacia, intraventricular hemorrhage of grade 3 or higher, and bronchopulmonary dysplasia.

It was seen that the rate of primary composite outcome was reduced by half in the study group (6% vs. 12%; relative risk, 0.49). Wound infection decreased by 65% (2.4% vs. 6.6%; RR, 0.35). 

Azithromycin significantly improved the maternal outcome like fever, readmission, revisit also.

The use of azithromycin was safe for neonates too and the researchers did not see much difference for the composite neonatal safety outcome in study vs the placebo group.   The rates for treatment and placebo groups were not different for suspected or confirmed sepsis (11.8% vs. 12.5%), serious neonatal morbidities (4.4% vs. 3.4%), or NICU admission (16.8% vs. 17%).

No maternal deaths were reported, 11 patients had allergic reaction, while five women admitted to intensive care, and five other had suspected cardiac events.

Concerns regarding the alteration of the fetal microbiome by brief systemic exposure to azithromycin were raised at the conference.

“We have collected additional information and specimens and we will be looking at these to try and answer this. We also hope to get funding to do a long-term evaluation of these kids. I will say that we collected adverse event data on them for 3 months and we did not see anything concerning, but I agree more needs to be done,” he said. “Having said that, azithromycin is something we already use quite a lot in obstetrics, and overall it has been shown to be safe for the newborn.”

Dr. Tita reported having no financial disclosures.

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