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Alexis®

Wound Protectors/Retractors

360o Wound Protection360o Atraumatic Retraction• Maximizes exposure, minimizes incision size

• Offers ultimate versatility© 2013 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. SC01531H

REORDER NO. SIZE QUANTITYFeaturing a rigid retraction ring for superior exposure

C8401C8402C8403C8404 C8405

Small, 2.5 - 6cmMedium, 5 - 9cm Large, 9 - 14cmX-Large, 11 - 17cm XX-Large, 17 - 25cm

5/BOX5/BOX 5/BOX5/BOX 5/BOX

Alexis® O Wound Protector/Retractor

REORDER NO. SIZE QUANTITYFeaturing a flexible retraction ring for maximum comformity

C8313C8312 C8301 C8302 C8303 C8304

XX-Small, 1 - 3cmX-Small, 2 - 4cm Small, 2.5 - 6cm Medium, 5 - 9cm Large, 9 - 14cm X-Large, 11 - 17cm

5/BOX5/BOX 5/BOX5/BOX 5/BOX5/BOX

Alexis Wound Protector/Retractor

REORDER NO. SIZE QUANTITY

C8701C8702

Small, 2.5 - 6cmMedium, 5 - 9cm

5/BOX5/BOX

Alexis Laparoscopic System with Kii® Fios® First Entry

REORDER NO. SIZE QUANTITY

G6313G6314

Large, 9 - 14cm X-Large, 11 - 17cm

5/BOX5/BOX

Alexis O C-Section Retractor

REORDER NO. SIZE QUANTITY

HR001HR004 HR005

Small/Small, 2.5 - 8cm Small/Medium, 2.5 - 8cm Medium/Large, 5 - 13cm

5/BOX5/BOX 5/BOX

Alexis Orthopaedic Protector

For more information www.appliedmedical.com/alexis

Provides 360o Atraumatic Circumferential Retraction· Distributes force evenly for optimal field of view

· Allows for maximum exposure with a minimum incision size

· Provides unparalleled exposure without trauma associated with prolonged point retraction

Provides 360o Protection· Maintains moisture at the incision site

· Allows visualization of wound margins

Offers Ultimate Versatility· Multiple sizes accommodate a wide range of surgeries

· Unique design facilitates rapid and effortless setup

Procedural Applications

CARDIOTHORACIC

BARIATRICLap Sleeve Gastrectomy (XXS) Lap Gastric Bypass (XS, S) Open Gastric Bypass (L, XL)

OB/GYN

GENERALInguinal Hernia Repair (XS, S) Thyroidectomy (XS, S) Appendectomy (S, M)

Video-Assisted Thoracoscopic Surgery (VATS) (XXS, XS, S) Mitral Valve Repair/Replacement (S, M) Thoracotomy (S, M)

Postpartum Tubal Ligation (XXS, XS)Bilateral Salpingo Oophorectomy (XS, S) Lap Hysterectomy (S, M Laparoscopic System) Mini-Laparotomy (S, M)

COLON & RECTAL

ORTHOPAEDIC

Stoma Formation (XXS) Lap Colectomy (S, M Laparoscopic System)Open Colectomy (L, XL, XXL)

Total Shoulder Arthroplasty (S/S) Total Hip Arthroplasty (S/M, M/L)

Myomectomy (S, M) Total Abdominal Hysterectomy (S, M, L) Cesarean Section (L, XL)

Splenectomy (L, XL) Pancreatectomy (L, XL)Whipple (XXL)

IS ALEXIS® PART OF YOUR STANDARD OF CARE?

BRAND

Reid, et al. 1 Lee, et al. 2 Horiuchi, et al. 3

Alexis Wound Protector/Retractor

Standard Retractors

4.69% (3/64)

79% RRR*

P = 0.004

89% RRR* 100%

RRR*

1.6% (1/61) 0%

(0/111)

P = 0.02P = 0.0021

22.7% (15/66)

14.6% (7/48)

8.1% (9/110)

Rate of Superf icial Incisional SSI

1. Reid K., et al. Barrier Wound Protection Decreases Surgical Site Infection in Open Elective Colorectal Surgery: A Randomized Clinical Trial. Dis Colon Rectum. 2010 Oct; 53(10): 1374-1380.2. Lee P., et al. Use of Wound-Protection System and Postoperative Wound-Infection Rates in Open Appendectomy. Arch Surg. 2009 Sep; 144(9): 872-875.3. Horiuchi T., et al. Randomized Controlled Investigation of the Anti-Infective Properties of the Alexis Retractor/Protector of Incision Sites. J Trauma. 2007 Jan; 62(1): 212-215.

*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.

Provides 360o Atraumatic Circumferential Retraction· Distributes force evenly for optimal field of view

· Allows for maximum exposure with a minimum incision size

· Provides unparalleled exposure without trauma associated with prolonged point retraction

Provides 360o Protection· Maintains moisture at the incision site

· Allows visualization of wound margins

Offers Ultimate Versatility· Multiple sizes accommodate a wide range of surgeries

· Unique design facilitates rapid and effortless setup

Procedural Applications

CARDIOTHORACIC

BARIATRICLap Sleeve Gastrectomy (XXS) Lap Gastric Bypass (XS, S) Open Gastric Bypass (L, XL)

OB/GYN

GENERALInguinal Hernia Repair (XS, S) Thyroidectomy (XS, S) Appendectomy (S, M)

Video-Assisted Thoracoscopic Surgery (VATS) (XXS, XS, S) Mitral Valve Repair/Replacement (S, M) Thoracotomy (S, M)

Postpartum Tubal Ligation (XXS, XS)Bilateral Salpingo Oophorectomy (XS, S) Lap Hysterectomy (S, M Laparoscopic System) Mini-Laparotomy (S, M)

COLON & RECTAL

ORTHOPAEDIC

Stoma Formation (XXS) Lap Colectomy (S, M Laparoscopic System)Open Colectomy (L, XL, XXL)

Total Shoulder Arthroplasty (S/S) Total Hip Arthroplasty (S/M, M/L)

Myomectomy (S, M) Total Abdominal Hysterectomy (S, M, L) Cesarean Section (L, XL)

Splenectomy (L, XL) Pancreatectomy (L, XL)Whipple (XXL)

IS ALEXIS® PART OF YOUR STANDARD OF CARE?

BRAND

Reid, et al. 1 Lee, et al. 2 Horiuchi, et al. 3

Alexis Wound Protector/Retractor

Standard Retractors

4.69% (3/64)

79% RRR*

P = 0.004

89% RRR* 100%

RRR*

1.6% (1/61) 0%

(0/111)

P = 0.02P = 0.0021

22.7% (15/66)

14.6% (7/48)

8.1% (9/110)

Rate of Superf icial Incisional SSI

1. Reid K., et al. Barrier Wound Protection Decreases Surgical Site Infection in Open Elective Colorectal Surgery: A Randomized Clinical Trial. Dis Colon Rectum. 2010 Oct; 53(10): 1374-1380.2. Lee P., et al. Use of Wound-Protection System and Postoperative Wound-Infection Rates in Open Appendectomy. Arch Surg. 2009 Sep; 144(9): 872-875.3. Horiuchi T., et al. Randomized Controlled Investigation of the Anti-Infective Properties of the Alexis Retractor/Protector of Incision Sites. J Trauma. 2007 Jan; 62(1): 212-215.

*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.

http://contact.appliedmedical.com/

Alexis®

Wound Protectors/Retractors

360o Wound Protection360o Atraumatic Retraction• Maximizes exposure, minimizes incision size

• Offers ultimate versatility© 2013 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. SC01531H

REORDER NO. SIZE QUANTITYFeaturing a rigid retraction ring for superior exposure

C8401C8402C8403C8404 C8405

Small, 2.5 - 6cmMedium, 5 - 9cm Large, 9 - 14cmX-Large, 11 - 17cm XX-Large, 17 - 25cm

5/BOX5/BOX 5/BOX5/BOX 5/BOX

Alexis® O Wound Protector/Retractor

REORDER NO. SIZE QUANTITYFeaturing a flexible retraction ring for maximum comformity

C8313C8312 C8301 C8302 C8303 C8304

XX-Small, 1 - 3cmX-Small, 2 - 4cm Small, 2.5 - 6cm Medium, 5 - 9cm Large, 9 - 14cm X-Large, 11 - 17cm

5/BOX5/BOX 5/BOX5/BOX 5/BOX5/BOX

Alexis Wound Protector/Retractor

REORDER NO. SIZE QUANTITY

C8701C8702

Small, 2.5 - 6cmMedium, 5 - 9cm

5/BOX5/BOX

Alexis Laparoscopic System with Kii® Fios® First Entry

REORDER NO. SIZE QUANTITY

G6313G6314

Large, 9 - 14cm X-Large, 11 - 17cm

5/BOX5/BOX

Alexis O C-Section Retractor

REORDER NO. SIZE QUANTITY

HR001HR004 HR005

Small/Small, 2.5 - 8cm Small/Medium, 2.5 - 8cm Medium/Large, 5 - 13cm

5/BOX5/BOX 5/BOX

Alexis Orthopaedic Protector

For more information www.appliedmedical.com/alexis

Clinical Evidence

“Only the use of a wound protector was found to significantly reduce the risk of wound infections in an adjusted analysis.”

Lee K.-W., et al. Use of an Upper Midline Incision for Living Donor Partial Hepatectomy: A Series of 143 Consecutive Cases. Liver Transpl. 2011 Aug; 17(8): 969-975.

Supporting the use of the Alexis® wound protector/retractor

“Superficial incisional SSI was significantly diminished in the ALEXIS wound retractor group (P=0.006).”...“The ALEXIS wound retractor is more effective in preventing SSI in elective colorectal resections compared with conventional methods.”

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. 2012 Jun; 14(6): 346-351.

“[E]nteric organisms were cultured twice as often from the inside surface of the retractor compared with the outside surface of the retractor (49% vs 26%, respectively; P < 0.0001).”...“[U]se of a plastic wound retractor may result in reduced enteric bacterial colonization of the surgical incision site during gastrointestinal surgery. Reduced colonization of the surgical incision site by enteric bacteria due to the use of a plastic wound retractor should result in a reduction in SSI following gastrointestinal surgery.”

Mohan H. M., et al. Plastic wound retractors as bacteriological barriers in gastrointestinal surgery: a prospective multi-institutional trial. J Hosp Infect. 2012 Jun; 81(2): 109-113. Epub 2012 May 11.

“Laparoscopic colon and rectal resection using a clean and dirty technique, with sterile specimen extraction, re-gowning procedure and wound protection have proven to reduce the incidence of wound infections, for an overall SSI rate of 5.1% compared to previously reported rates of up to 30%.”

Nassif G., et al. Wound Infection After Colorectal Surgery In The Laparoscopic Era. SAGES Poster Session 2012.

“Impervious plastic wound protectors reduce the risk of SSI when employed in non-trauma-related gastrointestinal and biliary tract surgery. Wound protectors represent a safe and simple intervention that may reduce postoperative morbidity and mortality.”...“There was a nonsignificant trend toward greater protective effect in studies using a dual ring protector (RR = 0.31, 95% Cl 0.14-0.67, P = 0.003), rather than a single ring protector (RR = 0.83, 95% Cl 0.38-1.83, P = 0.64).”

Edwards J. P., et al. Wound Protectors Reduce Surgical Site Infection: A Meta-Analysis of Randomized Controlled Trials. Ann Surg. 2012 Jul; 256(1): 53-59.

“These results suggest that the [wound protector] protects an incision site from bacterial invasion.”...“[W]e consider that the low incidence of SSI may have resulted from the protective effects of the [wound protector].”

Horiuchi T., et al. A Wound Protector Shields Incision Sites from Bacterial Invasion. Surg Infect (Larchmt). 2010 Dec; 11(6): 501-503. Epub 2010 Sep.

“Our data demonstrate that a statistically significant reduction in the incidence of wound infection was achieved with the use of a wound-protection device. This device provides a simple intervention that may eventually have a large impact on the incidence of surgical wound infection and therefore annual health care expenditures.”

Lee P., et al. Use of Wound-Protection System and Postoperative Wound-Infection Rates in Open Appendectomy. Arch Surg. 2009 Sep; 144(9): 872-875.

“In this study the use of barrier wound protection in elective open colorectal resectional surgery resulted in a clinically significant reduction in incisional surgical site infections.”...“There was a significant reduction in the incidence of incisional surgical site infections when the wound protector was used: 3 of 64 (4.7%) vs 15 of 66 (22.7%).”

Reid K., et al. Barrier Wound Protection Decreases Surgical Site Infection in Open Elective Colorectal Surgery: A Randomized Clinical Trial. Dis Colon Rectum. 2010 Oct; 53(10): 1374-1380.

“The wound infection rate of the [left upper quadrant] trocar site was significantly decreased when utilizing the wound retractor (18% to 0%).”

Nunn A., et al. A Novel Approach to Preventing Wound Infections in Laparoscopic Roux-En-Y Gastric Bypass Patients. SAGES Poster Session 2008.

“We found that the wound retractor/protector prevented the incision site from drying, decreased tissue damage, and facilitated the migration of neutrophils, suggesting a preventive effect of the device with respect to wound infection.”...“The studied wound retractor/protector effectively protects wound tissue from damage due to environmental factors experienced during surgery.”

Horiuchi T., 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.

“The results of this study demonstrate that wound infection decreased significantly in the With Alexis retractor group.”...“It was suggested that the use of the Alexis wound retractor would protect surgical wounds from contamination by bacteria and thus prevent infection.”

Horiuchi T., et al. Randomized Controlled Investigation of the Anti-Infective Properties of the Alexis Retractor/Protector of Incision Sites. J Trauma. 2007 Jan; 62(1): 212-215.

“We have noticed a decrease in the incidences of wound infection after using the wound protector at our trocar site.”

Im A., et al. Infection Rates Using Protectors in Laparoscopic Gastric Bypass. SAGES Poster Session 2005.

Visit www.stopwoundinfection.com to learn more about surgical site infection prevention.