Study Shows Statistically Significant Reduction in Mothers’ Pain Following Cesarean Section with Use of Innovative Retractor

Use of Applied Medical’s Alexis® O C-Section
Protector/Retractor Has Shown Statistically Significant Reduction in
Mothers’ Surgical Site Infections, Bleeding and Postoperative Pain

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).

Contacts

Applied Medical
Loree Bowen, 949-713-7920
lbowen@appliedmedical.com