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 

ACOG Practice Bulletin 195: Prevention of Infection After Gynecologic Procedures (login required)

JAMA Full Text: Centers for Disease Control and Prevention Guideline for the Prevention of Surgical Site Infection, 2017

Ob/Gyn Updated Facebook page

  

Yet another warning from FDA against Removal of Uterine Fibroids with Ultrasonic Aspirators

FDA issued a guidance against use of Ultrasonic Surgical Aspirators for removal of uterine fibroids because of risk of unintended spread of uterine cancer in the process of suction by the aspirators, thereby, worsening the patient’s odds for survival.

Ultrasonic aspirators are multifunctional devices that break up and emulsify both hard and soft tissues with ultrasound energy and then suck them out of the body through a small incision. They're used by a wide variety of surgeons in both open and laparoscopic procedures, including the cytoreduction of advanced malignancies that can't be removed completely.

The FDA said that the device’s oscillating tip can disperse the tissue that it breaks up with ultrasonic waves, despite the fact that it is designed to suck up the tissue, and the risk of disseminating cancer cells is outweighed by the aspirator’s benefits, which include “more extensive tumor debulking, little or no collateral thermal damage, and the ability to avoid organ resection.”

However, when it comes to removing uterine fibroids, the risk of spreading occult cancer is not outweighed by the benefits, "particularly since there are alternative treatment options available," the FDA stated. The agency noted that there is "no reliable preoperative screening procedure to detect uterine sarcoma in women with presumed benign fibroids."

Under this guidance, the FDA also requires the manufacturers to add a contraindication label to labeling of the devices, with or without 510(k) clearances, within 120 days of the Oct. 30 release of the guidance: CONTRAINDICATION: This ultrasonic surgical aspirator device is not indicated for and should not be used for the fragmentation, emulsification, and aspiration of uterine fibroids.

ACOG has however openly opposed the FDA guidance against use of ultrasonic aspirators for fibroid removal by stating it to be “too rigid and eliminates patient choice.” ACOG also disagrees with FDA regarding existence of other safer alternatives to remove the fibroids and claims that abdominal hysterectomy carries more risk.

The US FDA  has already issued a communication discouraging the use of power morcellator was issued on April 17, 2014 and have resulted in 4% decline in rate of laparoscopic hysterectomies, says the results of cross sectional study published in forthcoming issue of Journal Obstetrics and Gynecology.

FDA issued the statement because of advocacy and anti-morcellator campaign by Amy Reed, MD, PhD, an anesthesiologist who died because of uterine leiomyosarcoma on Wednesday, May 24 at age of 44.

She underwent a laparoscopic hysterectomy in October 2013 for fibroid, but her undiagnosed, occult uterine leiomyosarcoma was upstaged because of dispersion in abdominal cavity by the use of power morcellator. Since then, the power morcellator is the focal point of a four-year debate that has divided the surgical field.

Based on an analysis of currently available data, the FDA has estimated that approximately 1 in 350 women who undergo hysterectomy or myomectomy for fibroids is found to have an unsuspected uterine sarcoma. 

FDA guidance PDF

Related articles:

Laparoscopic hysterectomies forleiomyomas on decline after FDA communication discouraging the use of power morcellator.

Debate escalates over morcellation ofuterine and fibroid specimens in Minimal Invasive Surgeries after FDA permits the marketing of PneumoLiner!

Power Morcellator: A Boon or Curse?Dr. Amy Reed, a staunch opponent of power morcellator loses battle to uterine cancer.

Laparoscopic hysterectomies for leiomyomas on decline after FDA communication discouraging the use of power morcellator.

The US FDA communication discouraging the use of power morcellator was issued on April 17, 2014 and have resulted in 4% decline in rate of laparoscopic hysterectomies, says the results of cross sectional study published in forthcoming issue of Journal Obstetrics and Gynecology.

FDA issued the statement because of advocacy and anti-morcellator campaign by Amy Reed, MD, PhD, an anesthesiologist who died because of uterine leiomyosarcoma on Wednesday, May 24 at age of 44.

She underwent a laparoscopic hysterectomy in October 2013 for fibroid, but her undiagnosed, occult uterine leiomyosarcoma was upstaged because of dispersion in abdominal cavity by the use of power morcellator. Since then, the power morcellator is the focal point of a four-year debate that has divided the surgical field.

The researchers examined data from 4 states inpatient and ambulatory surgery database for year 2013 to 2014, and compared the rates of laparoscopic hysterectomy 15 months before and 9 months after the FDA announcement.

Women with a diagnosis of leiomyomas who underwent hysterectomy or myomectomy were included in the analysis.

Total 77,637 hysterectomies and myomectomies were performed during that period. The rate of laparoscopic hysterectomies declined from 62% of all hysterectomies before to 58% afterward with an accompanying increase in abdominal hysterectomies of 8% from 71% to 79%.

The rate of myomectomies in women with leiomyoma remained the same as compared to hysterectomies.

On April 7, 2016 The U.S. Food and Drug Administration today permitted the marketing of the first tissue containment system for use with certain laparoscopic power morcellators to isolate uterine tissue that is not suspected to contain cancer.

"PneumoLiner is intended to contain morcellated tissue in the very limited patient population for whom power morcellation may be an appropriate therapeutic option - and only if patients have been appropriately informed of the risks," FDA deputy director William Maisel said in a news release.

"This new device does not change our position on the risks associated with power morcellation. We are continuing to warn against the use of power morcellators for the vast majority of women undergoing removal of the uterus or uterine fibroids," Dr Maisel added.

Based on an analysis of currently available data, the FDA has estimated that approximately 1 in 350 women who undergo hysterectomy or myomectomy for fibroids is found to have an unsuspected uterine sarcoma. 

ACOG statement on power morcellator 

Abstract