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HomeCLINICAL TRIALS, STUDIES, DATAClinical Study Shows Efficacy of Dual-Ring Alexis Wound Protector in Lowering Surgical...

Clinical Study Shows Efficacy of Dual-Ring Alexis Wound Protector in Lowering Surgical Site Infection in Pancreaticoduodenectomy Procedures

Use of Applied Medical’s Alexis® Wound Protector Shows Statistically Significant Reduction in Incisional SSI Among Patient Group

July 17, 2018

Clinical study shows new clinical evidence demonstrates the value of Applied Medical’s Alexis wound protector/retractor in pancreaticoduodenectomy (PD) procedures, also known as Whipple procedures.

A study published this month in the Annals of Surgery showcases a significant reduction in PD surgical site infection (SSI) when the dual-ring Alexis wound protector/retractor was used. The Alexis wound protector/retractor lowered incisional SSI in PD procedures by 52 percent compared to cases that did not utilize a wound protector.

The volume of PD cases has been increasing over the past two decades,1 yet postoperative morbidity remains high, up to 40 percent in high-volume pancreatic centers,2 with a substantial amount resulting from SSI. The risk of incisional SSI is even higher in cases requiring biliary drainage prior to the procedure.1

In addition to reducing incisional SSI in PD procedures, the Alexis wound protector/retractor has been clinically proven to reduce incisional SSI across multiple surgical specialties.3-5 “It’s our company’s mission to make a meaningful, positive difference by enhancing surgical outcomes,” said Serene Wachli, president of the Horizon II Division at Applied Medical. “We’re proud to design, develop and manufacture our Alexis wound protectors, which have been shown to be effective in helping reduce SSI in a wide variety of procedures.”

Study Design: The study was a multicenter, parallel, dual-arm, double-blind, randomized controlled trial that evaluated the efficacy of the Alexis wound protector/retractor to reduce the risk of incisional SSI among patients with a biliary stent undergoing an elective PD. The study compared the use of the dual-ring wound protector to the current standard of care at the Foothills Medical Centre and The Ottawa Hospital in Calgary and Ottawa, Canada, respectively. The Alexis wound protector/retractor group was comprised of 57 patients and the no-wound-protector group was comprised of 50 patients. After observing that the risk of incisional SSI was significantly lower with the use of dual-ring wound protectors, the data safety panel stopped the trial at the first planned interim analysis due to the dramatically positive treatment effect and the understanding of the economic impact associated with addressing incisional SSI occurrence.1

SSI: SSI accounts for 20 percent of healthcare-associated infections,6 resulting in approximately $3.5 billion to $10 billion annual healthcare expenditures in the United States.7 Additionally, incisional SSI may lead to increased postoperative pain, poor wound healing and incisional hernias.8-12

Alexis Wound Protector: Developed and manufactured by Applied Medical, the Alexis wound protector/retractor features a dual-ring design in a wide range of sizes for use within multiple specialties. The Alexis wound protector/retractor features 360-degree protection to help reduce surgical site infection,1, 3-5, 13-14 shield incision sites from bacterial invasion15-16 and maintain moisture to promote healing.17


References

1. Bressan AK, Aubin J-M, Martel G, et al. Efficacy of a dual-ring wound protector for prevention of surgical site infections after pancreaticoduodenectomy in patients with intrabiliary stents: A randomized clinical trial. Ann Surg. 2018;268(1):35-40. (Level of Evidence 1)

2. Ceppa EP, Pitt HA, House MG, et al. Reducing surgical site infections in hepatopancreatobiliary surgery. HPB (Oxford). 2013;15(5):384-391. (Level of Evidence 3)

3. Reid K, Pockney P, Draganic B, Smith SR. Barrier wound protection decreases surgical site infection in open elective colorectal surgery: A randomized clinical trial. Dis Colon Rectum. 2010;53(10):1374-1380. (Level of Evidence 1)

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 Biol. 2016;203:232-238. (Level of Evidence 1)

5. Lee P, Waxman K, Taylor B, Yim S. Use of wound-protection system and postoperative wound-infection rates in open appendectomy: A randomized prospective trial. Arch Surg. 2009;144(9):872- 875. (Level of Evidence 1)

6. Klevens RM, Edwards JR, Richards CL Jr, et al. Estimating health care-associated infections and deaths in U.S. hospitals, 2002. Public Health Rep. 2007;122(2):160-166. (Level of Evidence 4)

7. Scott RD. The direct medical costs of healthcare-associated infections in U.S. hospitals and the benefits of prevention. https://www.cdc.gov/hai/pdfs/hai/scott_costpaper.pdf. Published March 2009. Accessed May 21, 2018. (Level of Evidence 4)

8. Horan TC, Culver DH, Gaynes RP, et al. Nosocomial infections in surgical patients in the United States. January 1986-June 1992. National Nosocomial Infections Surveillance (NNIS) System. Infect Control Hosp Epidemiol. 1993;14:73–80. (Level of Evidence 4)

9. Le Huu Nho R, Mege D, Quaissi M, et al. Incidence and prevention of incisional hernia. J Visc Surg. 2012;149:e3–e14. (Level of Evidence 4)

10. Alfonso JL, Pereperez SB, Canoves JM, et al. Are we really seeing the total costs of surgical site infections? A Spanish study. Wound Repair Regen. 2007;15:474–481. (Level of Evidence 4)

11. Perencevich EN, Sands KE, Cosgrove SE, et al. Health and economic impact of surgical site infections diagnosed after hospital discharge. Emerg Infect Dis. 2003;9:196–203. (Level of Evidence 4)

12. Cruse PJE, Foord R. A five-year prospective study of 23,649 surgical wounds. Arch Surg. 1973;107:206–210. (Level of Evidence 2)

13. Horiuchi T, Tanishima H, Tamagawa K, et al. Randomized, controlled investigation of the anti-infective properties of the Alexis retractor/protector of incision sites. J Trauma. 2007;62(1):212-215. (Level of Evidence 1)

14. Cheng KP, Roslani AC, Sehha N, et al. ALEXIS O-Ring wound retractor vs conventional wound protection for the prevention of surgical site infections in colorectal resections. Colorectal Dis. 2012;14(6):e346-e351. (Level of Evidence 1)

15. Mohan HM, McDermott S, Fenelon L, et al; Members of the University College Dublin Wound Retractor Study Group. Plastic wound retractors as bacteriological barriers in gastrointestinal surgery: A prospective multi-institutional trial. J Hosp Infect. 2012;81(2):109-113. (Level of Evidence 2)

16. Horiuchi T, Tanishima H, Tamagawa K, et al. A wound protector shields incision sites from bacterial invasion. Surg Infect (Larchmt). 2010;11(6):501-503. (Level of Evidence 4)

17. Horiuchi T, Nakatsuka S, Tanishima H, et al. A wound retractor/protector can prevent infection by keeping tissue moist and preventing tissue damage at incision sites. Helix Review Series: Infectious Diseases. 2007;(3):17-23. (Level of Evidence 5)

Medical Device News Magazinehttps://infomeddnews.com
Medical Device News Magazine is a division of PTM Healthcare Marketing, Inc. Pauline T. Mayer is the managing editor.

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