Alexis WOUND PROTECTORS/RETRACTORS. 360 o Wound Protection 360 o Atraumatic Retraction

Transcription

1 Alexis WOUND PROTECTORS/RETRACTORS 360 o Wound Protection 360 o Atraumatic Retraction

2 Applied Medical is dedicated to providing innovative products that improve patient outcomes and enable the advancement of minimally invasive surgery. As a new generation medical device company, we are equally committed to improving the affordability and accessibility of high-quality healthcare. To further our dedication to improving both hospital and patient outcomes, we are committed to being a part of the overall solution to reduce surgical site infection (SSI). Stopwoundinfection.com is a comprehensive resource for healthcare professionals interested in learning more about the prevention of SSI. Our mission is to improve patient outcomes by providing an educational forum to discuss clinically proven methods to reduce the incidence of SSI.

3 Programs that reduce the incidence of SSI can substantially decrease morbidity and mortality and reduce the economic burden for patients and hospitals. 4 Healthcare Impact SSI has added $3 to $10 billion to the cost of healthcare 5 2% to 5% of patients undergoing inpatient surgery will develop an SSI 6 there were over 290,000 cases of SSI in 2002, which resulted in over 8,000 deaths 7 Patient Impact On average, surgical site infection patients: spend an additional 7-10 days in the hospital 6 are 60% more likely to spend time in ICU 4 are 5 times more likely to be readmitted to the hospital 4 have a 2-11 times higher risk of death than patients without an SSI 6 require an additional cost of $11,087 to $34,670 per infection 5 References: 1. Reid K., B.Med., et al. Barrier Wound Protection Decreases Surgical Site Infection in Open Elective Colorectal Surgery: A Randomized Clinical Trial. Dis Colon Rectum Oct; 53(10): Lee P., MD., et al. Use of Wound-Protection System and Postoperative Wound-Infection Rates in Open Appendectomy. Arch Surg Sep; 144(9): Horiuchi T., MD. PhD., et al. Randomized Controlled Investigation of the Anti-Infective Properties of the Alexis Retractor/Protector of Incision Sites. J Trauma Jan; 62(1): Kirkland K., MD., et al. The Impact of Surgical-Site Infections in the 1990s: Attributable Mortality, Excess Length of Hospitalization, and Extra Costs. Infect Control Hosp Epidemiol 1999; 20: Scott, R. Douglas. The Direct Medical Costs of Healthcare-Associated Infections in U.S. Hospitals and the Benefits of Prevention. March Anderson DJ, et al. Strategies to Prevent Surgical Site Infections in Acute Care Hospitals. Infect Control Hosp Epidemiol 2008;29:S51-S61 for individual references. 7. Klevens RM, et al. Estimating Healthcare-Associated Infections and Deaths in U.S. Hospitals, Public Health Rep2007;122:

4 Alexis - [ä-lek-sĭs] Origination: Greek. Definition: Protector of Human-kind. Contents: Product Information Clinical Support Procedural Photos Product Lines For more information Applied Medical Resources Corporation. All rights reserved. Applied Medical, the Applied Medical logo design and marks designated with a are trademarks of Applied Medical Resources Corporation, registered in one or more of the following countries: Australia, Canada, Japan, the United States and/or the European Union. SC01366M

5 Product Information Protection Reduces superficial surgical site infection following colorectal surgeries 1, of wound protection Maintains moisture at the incision site 2 1

6 Product Information Retraction 360 of circumferential retraction Distributes force evenly, eliminating point trauma and associated pain 2

7 Product Information Exposure Maximizes exposure, minimizes incision size Allows visualization of wound margins Frees up valuable hands in the Operating Room 3

8 Guidelines for Laparoscopic Resection of Curable Colon and Rectal Cancer. SAGES Publication #32, February

9 IS ALEXIS PART OF YOUR BRAND STANDARD OF CARE? Rate of Superf icial Incisional SSI 22.7% (15/66) Alexis Wound Protector/Retractor Standard Retractors P = % RRR* 4.69% (3/64) 14.6% (7/48) P = % P = RRR* 100% 8.1% RRR* (9/110) 1.6% (1/61) 0% (0/111) Reid, et al. 1 Lee, et al. 2 Horiuchi, et al. 3 *RRR (relative risk reduction) was defined as the proportion of the control group (standard retractors) experiencing a given outcome minus the proportion of the treatment group (Alexis protector) experiencing the outcome, divided by the proportion of the control group (standard retractors) experiencing the outcome. 5

10 Edwards J. P., MD. MPH. CPH., et al. Wound Protectors Reduce Surgical Site Infection: A Meta- Analysis of Randomized Controlled Trials. Ann Surg Jul; 256(1):

11 Mohan H. M., et al. Plastic wound retractors as bacteriological barriers in gastrointestinal surgery: a prospective multi-institutional trial. J Hosp Infect Jun; 81(2): Epub 2012 May 11. 7

12 Cheng K. P., et al. ALEXIS O-Ring wound retractor vs conventional wound protection for the prevention of surgical site infections in colorectal resections. Colorectal Dis Jun; 14(6):

13 Lee K.-W., et al. Use of an Upper Midline Incision for Living Donor Partial Hepatectomy: A Series of 143 Consecutive Cases. Liver Transpl Aug; 17(8):

14 Horiuchi T., MD. PhD., et al. A Wound Protector Shields Incision Sites from Bacterial Invasion. Surg Infect (Larchmt) Dec; 11(6): Epub 2010 Sep. 10

15 Reid K., B.Med., et al. Barrier Wound Protection Decreases Surgical Site Infection in Open Elective Colorectal Surgery: A Randomized Clinical Trial. Dis Colon Rectum Oct; 53(10):

16 Lee P., MD., et al. Use of Wound-Protection System and Postoperative Wound-Infection Rates in Open Appendectomy. Arch Surg Sep; 144(9):

17 Horiuchi T., MD. PhD., 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:

18 Horiuchi T., MD. PhD., et al. Randomized Controlled Investigation of the Anti-Infective Properties of the Alexis Retractor/Protector of Incision Sites. J Trauma Jan; 62(1):

19 Emerging Technology Posters - SAGES 2012 Wound Infection After Colorectal Surgery In The Laparoscopic Era G Nassif DO, D Ortiz MD, J Frenkel MD, S Berman BS, D Keller MD, G Marks MD, J Marks MD Lankenau Hospital and Institute for Medical Research, Wynnewood, PA, USA 15

20 16 Clinical Support

21 Emerging Technology Posters - SAGES 2008 A NOVEL APPROACH TO PREVENTING WOUND INFECTIONS IN LAPAROSCOPIC ROUX-EN-Y GASTRIC BYPASS PATIENTS Andre Nunn, MD, FACS S. Perdue, PA-C Wayne State University, Harper Hospital, Detroit, Michigan Wound infections following laparoscopic Rouxen-Y gastric bypass (LRYGB) surgery are a wellknown and potentially serious complication. In our practice, the left upper quadrant trocar (LUQ) site through which the circular stapler is inserted is the most often infected wound. A new barrier method for protecting this particular wound is presented. Methods: A wound retractor (Applied Medical, figure 1) was inserted in the lateral 15mm trocar site (figure 2) prior to introduction of the circular stapler (figure 3). Retrospective data was analyzed, comparing patient groups in which the wound retractor was utilized (n=26) and in which the device was not (n=11) Results: Wound infection rates were compared between patients undergoing LRYGB between June and November 2007 (n=37). The wound infection rate of the LUQ trocar site was significantly decreased when utilizing the wound retractor (18% to 0%) Conclusion: Although the number of patients in this retrospective study is limited, the wound retractor has proven beneficial in preventing wound infections. This is likely secondary to the prevention of contamination of the wound by the circular stapler. A randomized prospective study would be needed to confirm and validate these results. Figure 1 Figure 2 Figure 3 17

22 The American College of Obstetricians and Gynecologists Use of a Hands-Free Abdominal Retractor During Cesarean Delivery: A Randomized, Controlled Trial John Robert Conatser, MD Medical University of South Carolina, Charleston, South Carolina Ana Panduro, MD; Angela M. Savatiel, MD; Cecil H. Nelson, III; Scott Allan Sullivan, MD Objective: To determine whether use of a hands-free retraction device during cesarean delivery reduced operative time, blood loss, wound complications, or improved physician satisfaction. Design: This was a randomized, prospective, controlled clinical trial. Patients undergoing cesarean delivery from 2007 to 2009 were randomized to cesarean delivery performed either with traditional metal retractors or a hands-free abdominal retraction device. (Alexis retractor, Applied Medical) Patients were blinded to their assignment, but surgeons were not. The primary outcomes were operative time, estimated blood loss, and primary surgeon satisfaction with visualization during the surgery. Secondary outcomes included wound complications, change in hemoglobin, and assistant surgeon satisfaction. Results: 220 subjects were enrolled into the trial, 108 in the control group and 112 in the hands-free retractor group. The groups did not differ in age (P<.24), parity (P<.73) race (P<.82) or indication for cesarean delivery (P<.66). There was a significantly decreased operating time (54.5 minutes versus 62.3 minutes P<.04). There was no difference in estimated blood loss (P<.63) There were decreased overall wound complications with the hands-free retractor, but this difference was not significant (P<.20). Primary assistant surgeons reported higher overall satisfaction with the use of the hands-free retractor (P<.0001 and P<.0001) and with visualization during the surgery (P<.0001 and P<.003). Conclusion: Use of a hands-free abdominal retractor during cesarean delivery significantly reduced operative time compared with traditional retractors. Surgeons and assistants reported that use of the hands-free retractor resulted in greater visualization and higher satisfaction with the surgery. 18

23 Procedural Photos COLECTOMY GASTRIC BYPASS THORACOTOMY THYROIDECTOMY 19

24 Procedural Photos HYSTERECTOMY MYOMECTOMY POSTPARTUM TUBAL LIGATION C-SECTION 20

25 Product Lines Product Lines The Alexis wound protectors are indicated for soft tissue and thoracic retraction. Suggested uses: General Surgery Inguinal Hernia Repair (XS, S) Thyroidectomy (XS, S) Appendectomy (S, M) Pancreatectomy (L, XL) Splenectomy (L, XL) Whipple (XXL) Bariatric Lap Sleeve Gastrectomy (XXS) Lap Gastric Bypass (XS, S) Open Gastric Bypass (L, XL) Colon & Rectal Stoma Formation (XXS) Lap Colectomy (S, M) Open Colon (L, XL) Cardiothoracic Video-Assisted Thoracoscopic Surgery (VATS) (XXS, XS, S) Mitral Valve Repair/Replacement (S, M) Thoracotomy (S, M) OB/GYN Postpartum Tubal Ligation (XXS, XS) Bilateral Salpingo Oophorectomy (XS, S) Mini-Laparotomy (S, M) Myomectomy (S, M) Total Abdominal Hysterectomy (S, M) Lap Hysterectomy (S, M Lap System) Cesarean Section (L, XL) Orthopaedic Total Shoulder Arthroplasty (S/S) Total Hip Arthroplasty (S/M, M/L) *The product size recommendations above are meant as a guideline. XXL XL S XXS L M XS 21

26 Product Lines Product Lines Alexis O Wound Protector/Retractor Featuring a rigid retraction ring for superior exposure C8401 Small 2.5-6cm incisions C8402 Medium 5-9cm incisions C8403 Large 9-14cm incisions C8404 X-Large 11-17cm incisions C8405 XX-Large 17-25cm incisions Alexis Wound Protector/Retractor Featuring a flexible retraction ring for maximum conformity C8313 XX-Small 1-3cm incisions C8312 X-Small 2-4cm incisions C8301 Small 2.5-6cm incisions C8302 Medium 5-9cm incisions C8303 Large 9-14cm incisions C8304 X-Large 11-17cm incisions Alexis Laparoscopic System with Kii Fios First Entry C8701 Small 2.5-6cm incisions C8702 Medium 5-9cm incisions Alexis O C-Section Protector/Retractor G6313 Large 9-14cm incisions G6314 X-Large 11-17cm incisions Alexis Orthopaedic Protector HR001 Small/Small 2.5-8cm incisions HR004 Small/Medium 2.5-8cm incisions HR005 Medium/Large 5-13cm incisions 22

27 A New Generation Medical Device Company A New Generation Medical Device Company