Applied Medical Release: Study Shows Statistically Significant Reduction In Mothers’ Pain Following Cesarean Section With Use Of Innovative Retractor

RANCHO SANTA MARGARITA, Calif.--(BUSINESS WIRE)--Cesarean section (C-section) is the most common operation performed on women of reproductive age worldwide, totaling an estimated one in three U.S. births. A recent study published in the European Journal of Obstetrics & Gynecology and Reproductive Biology showed significantly lower pain scores when the Alexis O C-Section Retractor from Applied Medical was used, with 81 percent of mothers rating pain at discharge as 0 or 1 compared to 4 percent of mothers in the metal retractor group (scale of 0-10). In addition, the need for extra post-operative pain treatment was half as frequent in the Alexis O C-Section Retractor group.¹ The study further showed that the use of the Alexis O C-Section Retractor resulted in a statistically significant reduction in the rate of surgical site infections (SSI) (1 percent vs. 8 percent).

Additional findings showed 77 percent of women in the Alexis O C-Section Retractor group did not need their uterus exteriorized for post-delivery suturing,² a technique that is associated with increased nausea and discomfort post-delivery. Furthermore, a greater majority of women experienced minimal blood loss³ in the Alexis O C-Section Retractor group.

“Since I began using the Alexis O C-Section Retractor in my cesarean sections, I have seen a drastic improvement in the new mom’s ability to begin breastfeeding her newborn. The Alexis O C-Section Retractor has also decreased the need for strong, painful pressure to be exerted on the uterine fundus to deliver the baby. My cesarean section patients usually go home on post-op day #2 and the use of opiate medications by my patients has significantly decreased,” said Dr. Jamie Lipeles of Marina Obstetrics and Gynecology. “Any new mother will tell you that pain following delivery, depending on its severity, can significantly impact her ability to quickly bond with her new baby. This new data, showing the wide ranging benefits of using the Alexis O C-Section Retractor in patients requiring a cesarean delivery, demonstrates clear benefits for not only my patients, but their newborns as well.”

“As a mother who has delivered both of her children through cesarean section, the first with traditional metal retractors and the second with the Alexis O C-Section Retractor, I have first-hand experience with the dramatic reduction in post-procedure pain when using the Alexis retractor. We’ve heard the same feedback from so many surgeons over the years, so it’s exciting to have these findings validated in this study,” said Serene Wachli, president of Horizon II Division at Applied Medical. “In my professional role, working closely with surgeons to help develop innovative solutions that improve patient care, I’m equally pleased with the benefits the researchers experienced. That balance of meeting surgical needs and delivering patient benefits is always Applied’s ultimate goal.”

The researchers for the study also gathered surgeon input, with surgeons agreeing that the Alexis O C-Section Retractor provided easier placement, improved visualization of the operative field and enabled greater freedom of surgical movement.

Study Design

The study was a single center, prospective, randomized, controlled trial comparing the use of Alexis O C-Section Retractors with traditional Collins metal retractors in low-risk women having their first C-section at the Department of Obstetrics, Charité University Hospital Berlin in Berlin, Germany. Ninety-eight women were in the Alexis O C-Section Retractor group and 100 were in the traditional metal retractor group.

About the Alexis O C-Section Retractor

Developed and manufactured by Applied Medical, the Alexis O C-Section Retractor provides 360° of atraumatic retraction and protection during cesarean delivery. By offering hands-free retraction, the Alexis O C-Section Retractor delivers maximum intra-abdominal exposure, which increases operating room (OR) efficiency and may reduce OR time, while also reducing point trauma and post-operative pain. Additionally, the Alexis O C-Section Retractor protects the wound margin from contamination, which has been shown to reduce surgical site infection.⁴

About Applied Medical

Applied Medical is dedicated to providing innovative solutions that enhance patient outcomes and enable the advancement of minimally invasive surgery. As a new generation medical device company, Applied is proud to have a significant and sustainable impact on healthcare by delivering breakthrough technologies that enhance clinical care and satisfy the pressing economic needs of our customers.

Founded in 1987 and headquartered in Southern California, Applied Medical is a rapidly growing, global organization with approximately 3,500 team members. We are proud to provide our products and unique business model to more than 75 countries.

For additional information, please visit www.appliedmedical.com.

1. 19% of women required extra post-operative pain treatment in the Alexis O C-Section Retractor group versus 43% in the metal retractor group.
2. 77% of women did not need their uterus to be exteriorized in the Alexis O C-Section Retractor group versus 31% in the metal retractor group.
3. 19% of women experienced blood loss of <500 ml in the Alexis O C-Section Retractor group versus 3% in the metal retractor group.
4. Hinkson L, Siedentopf J-P, Weichert A, Henrich W. Surgical site infection in cesarean sections with the use of a plastic sheath wound retractor compared to the traditional self-retaining metal retractor. Eur J Obstet Gynecol Reprod Bio. 2016;203:232-238. (Level of Evidence 1).