Showing posts with label SSI. Show all posts
Showing posts with label SSI. Show all posts

Thursday, September 20, 2018

Use of alternative antibiotics during C-section increase the odds of wound infection


Use of alternative antibiotics other than the standard recommendation of the first-generation cephalosporin is associated with increased risk of infection and other adverse events, according to a new analysis of more than 6500 cesarean section deliveries. Cephazolin in the drug of choice for surgical prophylaxis in C-section deliveries.

"Use of both standard alternative and inappropriate alternative antibiotics was associated with higher odds of surgical site infections compared with the use of cefazolin for prophylaxis at the time of cesarean delivery," conclude the authors in the study published September 7 in Journal Obstetrics & Gynecology.

The American College of Obstetricians and Gynecologists (ACOG) recommend an infusion of intravenous 1 g cefazolin within 60 min before skin incision. For women with (BMI >30 kg/m 2 or weight > 100 kg, a dose of 2 g cefazolin intravenous infusion is recommended.

In women who are allergic to cephalosporin ACOG recommends alternative antibiotics, such as clindamycin combined with an aminoglycoside.

In this retrospective cohort study conducted over a period of 5 years (2012 – 2017), Tetsuya Kawakita, MD, Department of Obstetrics and Gynecology, MedStar Washington Hospital Center, Washington, DC, and colleagues analyzed data from 6584 women who had cesarean delivery in their center.

Majority of women, 6163(93.6%) received standard cefazolin, 274 (4.2%) received the standard alternative, while 147 (2.2%) received inappropriate alternatives— mostly clindamycin or gentamycin.

Propensity score adjusted logistic regression showed that use of alternative antibiotic was not associated with increased risk of the composite primary outcome namely endometritis, cellulitis, deep-wound infection, abdominopelvic abscess, and sepsis. But a subgroup analysis revealed that use of alternative antibiotic increased chances of cellulitis by 93% as compared to use of cephalosporins (adjusted odds ratio [OR], 1.93; 95% CI, 1.03 - 3.31).

Patient receiving alternative antibiotic faced nearly twice the risk of visiting the ER for wound complication (adjusted OR, 2.34; 95% CI, 1.19 - 4.18) compared with cefazolin.

Similarly, use of inappropriate antibiotics increased the odds of primary outcome nearly 4 times as compared to cephazolin (adjusted OR, 4.13; 95% CI, 2.59 - 6.36), while odds of endometritis (adjusted OR, 6.68; 95% CI, 3.69 - 11.44) and cellulitis (adjusted OR, 3.23; 95% CI, 1.63 - 5.81) also increased drastically.

The authors speculated that the difference in sensitivity of skin bacterial flora to the alternative antibiotics might be responsible for increased odds of having cellulitis after the C-section. More studies are warranted on alternate antibiotics other than those recommended by ACOG.

Besides, the authors also stressed that physicians should validate the patients claim of allergy to beta-lactam antibiotics and should not only rely on history given by the patients. They found that only 10-20% of patients documented true allergy on skin testing.

If patients gave a history of nonsignificant beta-lactam allergies, use of cefazolin in such patients might lower the risk of adverse event during cesarean delivery.


More on prevention of sepsis during cesarean deliveries:

Thursday, September 13, 2018

CDC encourages healthcare professionals to recognize early signs and symptoms of worsening infection and sepsis


Today is world sepsis day, the Center for Disease Control (CDC) urges healthcare professionals to recognize and educate patients and their families about the early signs and symptoms of worsening infection and sepsis.


Sepsis is a Global health crisis, affecting up to 30 000 000 people a year. Maternal Sepsis is one of the five-leading cause of death during pregnancy. Early recognition and prompt treatment of maternal sepsis is necessary to improve patient outcomes.


ACOG has recently issued guidance on prevention of surgical-site infection in gynecologic surgery. The practice bulletin includes guidelines about pre-operative and intraoperative prophylaxis, procedure-based antibiotic regimen, guidelines for patients with a history of Methicillin-resistant Staphylococcus aureus (MRSA) colonization, and penicillin allergy.

Find the guidelines here. Some other articles about preventing surgical site wound infection in obstetrics and gynecological surgeries are:

Chlorhexidine-Alcohol is not superior to Povidone-Iodine in reducing the rate of surgical site infection in Cesarean section reports the results of Chlorhexidine-Alcohol Versus Povidone-Iodine for Cesarean Antisepsis (CAPICA) Trial published ahead of print in American Journal of Obstetrics and Gynecology.

Results of a randomized controlled trial presented at the ACOG 2017 showed that changing the outer gloves before closing the abdomen decreases the wound complication of infection, cellulitis, and dehiscence.

Preincisional extended antibiotic prophylaxis does not prevent the 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.

Prescient Surgical got the green signal from FDA’s Center for Devices & Radiological health for de novo clearance of its CleanCision wound retraction and protection system.  The clearance could not have come at a better time because "Hospitals are increasingly focusing on infection control to improve patient care as a primary goal. Prescient's success with the CleanCision device bodes well for providers driven towards the 'triple aim' of quality of care, patient satisfaction, and reduced costs," says Brant Heise, Managing Director at Summation Health Ventures.

Use of poliglecaprone 25 (Monocryl) subcutaneous suture for abdominal wound closure in Cesarean Section reduces the wound complication rate by nearly 50 % as compared to use of polyglactin 910 (coated Vicryl) according to a study that will be presented at the 37th  annual meeting of Society for Maternal-Fetal Medicine , January 23-28 , Las Vegas.

A simple and inexpensive intervention of vaginal cleaning with an antiseptic solution before cesarean delivery brings down the rate of endometritis note the results of a Systematic Review and Meta-analysis published August 4 in Journal of Obstetrics and Gynecology.

VIDEO: “WHAT IS SEPSIS? (SEPSIS EXPLAINED IN 3 MINUTES)”






Monday, June 4, 2018

ACOG guidance on prevention of surgical-site infection in gynecologic surgery


Surgical site infection(SSI) after gynecological surgery is a significant cause of postoperative morbidity leading to repeated hospital visits.  These infections also incur heavy social and economic burden on patients and the healthcare system.

Two previous research papers have estimated that each SSI during a hysterectomy is going to add $5000 inpatient cost.

CDC defines SSI as an infection occurring at or near the surgical incision within 30 days of surgery and 12 months if a surgical implant was used.

A number of factors, both modifiable and not modifiable, contribute to the ultimate development of an SSI.

Steiner. Surgical-site infection in gynecologic surgery. Am J Obstet Gynecol 2017.


The recent ACOG practice bulletin is published in the June issue of Journal of Obstetrics and Gynecology and replaces Practice Bulletin Number 104, May 2009, and Committee Opinion Number 571, September 2013.

The practice bulletin includes guidelines about pre-operative and intraoperative prophylaxis, procedure-based antibiotic regimen, guidelines for patients with a history of Methicillin-resistant Staphylococcus aureus (MRSA) colonization, and penicillin allergy.

Preoperative prophylaxis:

Treat any remote infections before any elective gynecological procedure.

It is preferable not to shave the incision site unless it interferes with the procedure. When necessary, do not use a razor, clippers are preferred.

Screen women for diabetes before the procedure and if found hyperglycemic, aim at blood  glucose <200 mg/dL with or without diabetes.

Patients should have a full body shower or bath with Chlorhexidine instead of soap.

Pre-op abdominal skin preparation is preferably done with alcohol-based preparations, and chlorhexidine-alcohol was significantly more effective than a povidone-iodine scrub in preventing superficial and deep incisional infection.

Vaginal cleaning before surgery is done by 4% chlorhexidine gluconate or povidone-iodine, only povidone–iodine is FDA approved for vaginal preparation. Chlorhexidine gluconate with high alcohol concentration (70% isopropyl alcohol) is contraindicated for vaginal prep due to the risk of irritation.

Screen for bacterial vaginosis pre-operatively, if found positive initiate treatment with metronidazole or another CDC recommended regimen.

All members of the surgical team should maintain aseptic techniques and traffic in the OR should be limited

Intraoperative Prophylaxis:

Use excellent surgical techniques gentle tissue handling, good hemostasis, avoid hypothermia and short operative time < 100 minutes.

Use appropriate antimicrobial prophylaxis one hour before the surgery, in obese patients, the dose should be calculated accordingly.

In cases of long surgical procedures (> 4 hours) or blood loss > 1500 ml, repeat Cefazolin

Procedure based antibiotic regimens:

In all types of hysterectomy (abdominal, vaginal, laparoscopic, and robotic), Laparotomy, Vaginal sling, and Colporrhaphy: 2 g IV cefazolin (≤120 kg) and 3 g IV cefazolin (>120 kg)

In Uterine evacuation (suction D&C/D&E): 200 mg doxycycline orally or IV, Metronidazole is an effective second line of therapy.

No antibiotics are recommended: Colposcopy, Cervical tissue excision procedures (LEEP/biopsy/ECC), Endometrial biopsy, Cystoscopy, HSG, Hysteroscopy (operative/diagnostic), endometrial adhesions, IUD insertion, Oocyte retrieval and embryo transfer, D&C for nonpregnancy indications, and laparoscopic procedures.

History of MRSA Colonization or Infection:

It is recommended to follow the hospital protocol for MRSA antibiotic prophylaxis or a single preoperative intravenous dose of vancomycin (15 mg/kg) is included in the preoperative antibiotic prophylaxis regimen

Penicillin allergy:

In case of Immediate hypersensitivity reaction or Stevens-Johnson syndrome use Clindamycin 900 mg or metronidazole 500 mg PLUS Gentamicin 5mg/kg or aztreonam 2 g 

If there is no immediate hypersensitivity reaction (anaphylaxis, urticaria, bronchospasm) cephalosporins can be used. If there is a history of allergy to cephalosporins use Clindamycin 900 mg or metronidazole 500 mg PLUS Gentamicin 5mg/kg or aztreonam 2 g 



  


Wednesday, December 20, 2017

Novel CleanCision™ Wound Retraction system won FDA clearance for its abdominal wound Retraction and Protection System



Prescient Surgical, Inc., a medical device innovator based in San Carlos, California  just won FDA clearance for commercializing its novel CleanCision wound retraction and protection system.

This system is one of its kind, advanced surgical protection system designed by surgeons and infection control specialists. It is used by surgeons during abdominal surgery to retract the surgical incision, providing easy access to the surgical site while protecting the edges with an impermeable barrier thereby reducing the chances of wound infection. 


The device is placed in the wound and pulled apart, to open the radial fan like expanding system that is suitable for incisions ranging from 7-16 cm. The wound edges are continuously irrigated by an irrigant fluid of surgeon’s choice with the help of gravitational force from an external fluid bag and the excess is drained via a suction connected to the device. The impermeable inner layer of retractor prevents the wound contamination by fluids in the operative field.

Studies have shown a 61% reduction in rates of SSI using this device. The product is initially promoted for abdominal surgery and particularly colorectal surgery, where the risk, frequency and severity of surgical site infection is high, and the need is acute. But, it is useful in other specialties like Oncology and Ob/Gyn also.

The clearance could not have come at better time because "Hospitals are increasingly focusing on infection control to improve patient care as a primary goal. Prescient's success with the CleanCision device bodes well for providers driven towards the 'triple aim' of quality of care, patient satisfaction, and reduced costs," says Brant Heise, Managing Director at Summation Health Ventures.

The 2016 Surgical Site Infection updated guidelines, published by the American College of Surgeons and Surgical Infection Society, report that the risk of SSI is generally 2 to 5 percent with an estimated 160,000 to 300,000 SSIs occurring annually in the U.S.2 The rate of SSI can be as high as 15 to 30 percent in certain high-risk, clean-contaminated, and contaminated procedures such as colorectal surgery.3 National focus on SSI is increasing due to public reporting of surgical site infection rates and significant financial penalties imposed on hospitals, brought about by the Centers for Medicare and Medicaid Service's (CMS) Hospital-Acquired Condition Reduction Program.





Saturday, February 4, 2017

FDA clears CleanCision Wound Retractor to reduce surgical site infections.



http://www.prescientsurgical.com/

Prescient Surgical got green signal from FDA’s Center for Devices & Radiological health for de novo clearance of its CleanCision wound retraction and protection system.  The clearance could not have come at better time because "Hospitals are increasingly focusing on infection control to improve patient care as a primary goal. Prescient's success with the CleanCision device bodes well for providers driven towards the 'triple aim' of quality of care, patient satisfaction, and reduced costs,"says Brant Heise, Managing Director at Summation Health Ventures.

This system is used by surgeons during abdominal surgery to retract the surgical incision, providing easy access to the surgical site while protecting the edges with an impermeable barrier thereby reducing the chances of wound infection.

http://www.prescientsurgical.com/

 The CleanCision is a novel device, first of its kind and aids in the prevention of wound edge contamination. The device has a radial fan like expanding system that is suitable for incisions ranging from 7-16 cm.

http://www.prescientsurgical.com

Irrigant fluid is delivered to the wound edges by gravitational force from an external fluid bag and excess is drained via a suction connected to the device. The impermeable inner layer of retractor prevents the wound contamination by fluids in the operative field.

Wound irrigation and barrier wound protections are two strategies that have proved to reduce surgical site infection (SSI) are combined effortlessly in this one of its kind device.

Prescient Surgical CEO Jonathan Coe said in a statement "This news from the FDA marks a crucial milestone for Prescient Surgical and validates the hard work put in by our team and clinical partners towards our mission of reducing the risk of SSI. Most importantly, we can now look toward extending the promising results we've seen in recent clinical trials to the broader patient population."

Surgical site infections are the most common reason behind nosocomial infection, accounting for 31% of all Hospital Acquired Infections (HAIs) among hospitalized patients.[1]

The full product brochure can be accessed  here.



[1] Magill, S.S., et al., "Prevalence of healthcare-associated infections in acute care hospitals in Jacksonville, Florida". Infection Control Hospital Epidemiology, 33(3): (2012): 283-91.

Sunday, December 11, 2016

New Consensus statement to prevent surgical site infections after major gynecological surgery released.

image courtesy: http://www.3m.co.uk/3M/en_GB/company-uk/

Surgical site infections are the most common complications following surgery in United States. A recent prevalence study found that SSIs were the most common healthcare-associated infection, accounting for 31% of all HAIs among hospitalized patients.[1] The Estimated cost is $3.5 – 10 billion per year.[2]

Hysterectomy is the most common surgery performed in women, second to Cesarean section. A study by Uppal S et al, published in Journal of Obstetrics and Gynecology concluded that rate of SSI after gynecological surgery varies between 1.4 to 3.9%.

Implementation of recommendations provided by patient safety bundle can reduce the incidence of SSI by about 40-60% in any surgical environment.[3] Care Bundles are a set of evidence based practices that when performed collectively and reliably improves standard of care and patient outcome.[4]

Council on Patient Safety in Women's Health released a new consensus statement ‘the safety bundle’ that emphasizes good communication, standardization, maintaining a checklist and cooperation among team members to decrease the surgical site infection after major gynecological surgeries.[5]

The council’s working group include many major groups notably Society for Maternal Fetal Medicine, Society of Gynecologic Oncology and American College of Obstetricians and Gynecologists.

Published on line on December 2, 2016 and January 2017 issue of Obstetrics & Gynecology the consensus bundle mainly consists of four main domains readiness, recognition and prevention, response, and reporting and systems learning. 

Besides the usual recommendations and encouraging standardization of institutions the bundle emphasizes very good communications and spirit of teamwork between the surgical team members in each of its domain.

The main recommendations are:

  • Establishing standard for maintaining ambient operating room temperature and patient’s temperature. ( Normothermia)
  • Standardizing the time, choice and discontinuation of prophylactic antibiotics with proper records.
  • Uniformity in skin preparations preoperatively and postoperatively.
  • Each patients risk for SSI should be assessed before surgery based on BMI, Blood Glucose, smoking habits, nutritional status, methicillin resistant staphylococcus aureus (MRSA) and immunodeficiency status. Members of the surgical unit huddling to identify patients that are high risk for SSIs.
  • Continue to assess patient risk for SSI during operation based on blood loss, duration of surgery and contamination of surgical field.
  • Allocation of specific time during surgery to discuss antibiotic dose, prophylaxis and other specific issues pertaining to the patient.
  • Education of the patient and other family members regarding postoperative care especially in patients undergoing hysterectomy.
  • Developing a sound reporting system to collect, analyze and share infection data among different physician as a part of ongoing learning process.


A study conducted at Mayo clinic reported a significant and sustained reduction in SSI after implementation of the evidence based bundle in gynecological cancer surgeries. The rate for SSI before and after the intervention was 6.0%  and  1.1% (P = .01)[6]

The WHO also released first ever Global guidelines for the prevention of surgical site infection on 3 November 2016. They include a list of 29 concrete recommendations distilled by 20 of the world’s leading experts from 26 reviews of the latest evidence. The recommendations have also been published in The Lancet Infectious Diseases. [7] [8]




[1] Magill, S.S., et al., "Prevalence of healthcare-associated infections in acute care hospitals in Jacksonville, Florida". Infection Control Hospital Epidemiology, 33(3): (2012): 283-91
[2] Kirkland KB, Briggs JP, Trivette SL, et al. The impact of surgical-site infections in the 1990s: attributable mortality, excess length of hospitalization, and extra costs. Infection Control and Hospital Epidemiology. 1999;20:725-30.
[3] https://www.mnhospitals.org/Portals/0/Documents/patientsafety/SSI/Handout-Slashing-SSI-Raising-the-Bar-to-Lower-the-Rate.pdf
[4] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3218985/
[5] http://safehealthcareforeverywoman.org/wp-content/uploads/2016/09/Surgical-Site-Infections-Bundle-01-04-16.pdf
[6] http://journals.lww.com/greenjournal/Citation/2016/06000/Using_Bundled_Interventions_to_Reduce_Surgical.22.aspx
[7] http://www.thelancet.com/journals/laninf/article/PIIS1473-3099(16)30402-9/fulltext
[8] http://www.thelancet.com/journals/laninf/article/PIIS1473-3099(16)30398-X/fulltext