Alexis® O™ C-Section Retractor

A member of the Reviews in Obstetrics & Gynecology editorial board has reviewed the following devices. The views of the author are personal opinions and do not necessarily represent the views of Reviews in Obstetrics & Gynecology or MedReviews, LLC.

Companies can submit a product for review by e-mailing molson@medreviews.com.

• Design/Functionality Scale

  • 1 = Poor design; many deficits
  • 2 = Solid design; many deficits
  • 3 = Good design; few flaws
  • 4 = Excellent design; few flaws
  • 5 = Excellent design; flaws not apparent
• Value Scale

  • 1 = Added cost with limited benefit
  • 2 = Added cost with some benefit
  • 3 = Added cost but significant benefit
  • 4 = Marginal added cost but significant benefit
  • 5 = Significant cost savings
• Overall Scale

  • 1 = Don’t bother
  • 2 = Niche product
  • 3 = Worth a try
  • 4 = Must try
  • 5 = Must have

Evaluation

Design/Functionality: 4

Value: 1.5

Overall Score: 2.5

Background

In the United States, cesarean delivery has become one of the most frequently performed operations, with over 30% of births delivered abdominally. In addition to the numerous papers written to determine the cause of this rate increase, much attention has been focused on the surgical techniques of the procedure. In particular, the past 10 years have seen resurgence in the debate over exteriorization of the uterus for hysterotomy repair. Proponents of the exteriorization have extolled the ease with which the uterine incision is closed, whereas opponents have opined that the technique increases both infectious morbidity and postoperative pain. Muddying the waters further, a 2004 Cochrane Review concluded,” [t]here is no evidence from this review to make definitive conclusions about which method of uterine closure [extra-abdominal versus intra-abdominal] offers greater advantages, if any. However, these results are based on too few and too small studies to detect differences in rare, but severe, complications.”¹ A more recent randomized study by Coutinho and colleagues² from Brazil, published in Obstetrics & Gynecology in March 2008, was able to demonstrate no difference in infection morbidity. Procedures were shorter with exteriorization, but there was less pain at 6 hours with in situ repairs. The extraabdominal versus intra-abdominal debate appears reduced to surgeon preference. For those inclined towards in situ hysterotomy closures, exposure is an issue and, to this end, Applied Medical Resources Corporation (Rancho Santa Margarita, CA) offers the Alexis® O™ C-Section Retractor.

Design/Functionality

Alexis O C-Section Retractor is a disposable, single-use device that consists of a flexible polymer membrane formed into the shape of a cylinder. Attached to each end of the cylinder are 2 semirigid polymer rings. It is available in 2 sizes: large (for 9- to 14-cm incisions) and extra large (for 11- to 17-cm incisions). It is simple to set up and easy to use. After an abdominal incision is made, the Alexis O C-Section Retractor is placed in position through the incision with 1 ring inside the abdomen. The external ring is placed in traction and folded over itself until it contacts the abdomen. Once securely in place, the Alexis® wound retractor keeps the incision open during the procedure.³ With the uterus exposed, a hysterotomy is then performed and the infant is delivered through the retractor.

In testing by the author, the device performed as intended. It provided excellent exposure through a Pfannenstiel incision and closing the uterus in situ was easier than without it. On the downside, delivering the infant through the ring was a bit more cumbersome than without it and did raise an eyebrow of concern about the device’s use when difficult deliveries are encountered. The company claims the device provides wound “protection” in addition to hands-free retraction. Specifically, they claim the Alexis O C-Section Retractor “[s]ignificantly decreases wound infection.” This claim is based on a nicely done Japanese study of 221 patients that demonstrated a statistically significant reduction in surgical site infections in patient randomized to retraction with the Alexis O C-Section retractor.⁴ Unfortunately, the study was performed in patients undergoing colorectal surgery where perioperative infectious morbidity is about 25% to 40%, as compared with cesarean delivery, where the risk is closer to 5%.⁵ This fact, when taken in conjunction with the failure of intra-abdominal uterine closure to demonstrate a reduction in infections, renders this possible benefit less significant.

Design/Functionality Score: 4

Value

Priced at $75 per piece, the Alexis O C-Section Retractor is not cheap. For high-volume institutions such as Brigham and Women’s Hospital, in which upwards of 3000 cesarean deliveries are performed a year, this could yield a $225,000 per year increase in expenses. This added cost would be reasonable if there were demonstrable counterbalancing savings, but there are none. Thus, this device seems like added cost for only a marginal benefit at best.

Value Score: 1.5

Summary

The Alexis O C-Section Retractor is the Alexis wound retractor repackaged to try to appeal to the growing cesarean delivery market. Although the Alexis wound retractor occupies a helpful niche in open abdominal surgery (particularly for minilaparotomies), Alexis O C-Section Retractor does not appear to add a lot to operative obstetrics. Even for those in situ hysterotomy repair diehards, the benefits do not seem to justify the cost.

Overall Score: 2.5

Alexis® O™ C-Section Retractor (Applied Medical Resources Corporation, Rancho Santa Margarita, CA). Photo courtesy of Applied Medical Resources Corporation.