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

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FDA approves Senhance Surgical Robotic System to facilitate minimally invasive surgery

FDA today approved Senhance Systems, by TransEnterix, Inc., a medical device company that is pioneering the use of robotics to improve minimally invasive surgery.

Robotically-assisted surgical device (RASD) is a type of computer assisted surgical system, which helps surgeon to control, view and move the surgical devices through small ports of minimal invasive surgery in a variety of surgical procedures. It specifically has gynecological and colorectal applications.

The system enables the surgeon to sit in a console or a cockpit of some sort, which provides him or her with a 3D, high-definition view of the surgical field and allows for the control of the system’s 3 robotic arms. At the end of each of the 3 arms are mounted surgical instruments that are based on traditional laparoscopic instrument designs. This increases the surgeon’s comfort and reduces strain.

The system allows the surgeon to “feel” the stiffness of tissue during operation with its force feedback technology. It also features eye-tracking to allow for comparative movement of instruments to standard operations. It facilitates highly efficient operations with minimal additional docking time or change to technique.

 It allows for the visualization and endoscopic manipulation of human tissue, such as grasping, cutting, blunt and sharp dissections, approximation, ligation, electrocautery, suturing, mobilization and retraction in laparoscopic colorectal surgery and laparoscopic gynecological surgery," according to the FDA. 

“Minimally invasive surgery helps reduce pain, scarring and recovery time after surgery,” said Binita Ashar, M.D., director of the Division of Surgical Devices in the FDA’s Center for Devices and Radiological Health. “RASD technology is a specialized innovation in minimally invasive surgery designed to enhance the surgeon’s access and visualization within confined operative sites.” 

The clearance was based on results of a pilot study in which 150 patients underwent various gynecological operations with the Senhance System. The clinical outcomes were compared with outcomes of nearly 8000 surgeries in real world settings using another RASD.

In addition to gynecological surgeries, 45 colorectal sureries were also performed by Senhance system and compared to outcomes of other real-world surgeries.

Based on the study results, real world evidence and simulations, the FDA concluded that the  Senhance System is substantially equivalent to the da Vinci Si IS3000 device for gynecological and colorectal procedures.

Here is a  video of Senhance Surgical Systems. 


Senhance Surgical Robotic System - Functional Overview from TransEnterix, Inc on Vimeo.