Alexis®

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Alexis ウーンドプロテクター/リトラクターの使用による創部保護
表層SSIの発生率 － Alexis ウーンドプロテクター/リトラクター vs 標準開創器
22.7%(15/66)

Alexis ウーンドプロテクター/リトラクター20%(6/30)

P = 0.004
79%
RRR*

標準開創器

P = 0.006
100%
RRR*

4.69%
(3/64)

Reid, et al.1

14.6%(7/48)

0%(0/34)

Cheng, et al.2

P = 0.02
89%
RRR*
1.6%
(1/61)

Lee, et al.3

8.1%
(9/110)

P = 0.0021
100%
RRR*0%(0/111)

Horiuchi, et al.4

P = 0.035
87%
RRR*†8%(8/100)

1%(1/98)

Hinkson, et al.5

＊RRP（相対リスク低下）はコントロール群（標準開創器）の発生率からトリートメント群（Alexis ウーンドプロテクター/リトラクター）の発生率を引き、それをコントロール群（標準開創器）の発生率で割ったもの。
データは皮膚表層切開創 /切開部深層及び臓器・体腔のSSIを示す。

360°の創部保護
手術部位の感染を抑制します。1-5
創部をバクテリアの侵入から防ぎます。6,7
湿潤を維持して創部の治癒を促します。8360°の低侵襲な開創
必要最小限の切開長で大きく開創します。
局所的な開創に伴う侵襲や疼痛を軽減し、優れた開創を提供します。
ハンズフリーで開創ができるため、手で持つタイプの開創器で起こりうる煩わしさや不快感、疲れを軽減することが可能です。9圧迫止血効果が得られます。5

多様な手技に対応様々な専門分野、患者様の体型、切開長に対応する保護と開創が得られます。
迅速かつ容易なセットアップが可能です。

術式適用例結腸および直腸手術
腹腔鏡下結腸切除術（ラパロスコピックシステムS, M)
結腸切除術(L, XL, XXL)

肥満手術
腹腔鏡下胃バイパス術(XS, S)
胃バイパス術(L, XL)

一般外科手術
鼠径ヘルニア修復術(XS, S)
甲状腺摘出術(XS, S)
虫垂切除術(S, M)

脾摘出術(L, XL)
膵腫瘍切除術(L, XL)
膵頭十二指腸切除術（Whipple）(L, XL, XXL)

心胸郭手術
胸腔鏡補助下手術(XXS, XS, S)
僧帽弁修復術/置換術(S, M)
開胸術(S, M)

産婦人科手術
分娩後卵管結紮術(XXS, XS)
子宮筋腫摘出（核出）術(S, M)
子宮付属器切除術(XS, S)
子宮全摘出術(S, M, L)
腹腔鏡下子宮全摘出術（ラパロスコピックシステムS, M) 帝王切開術(C-セクション
小切開術(S, M)
プロテクター/リトラクター L, XL)

乳腺手術
乳房部分切除術(XS, S)
乳房切除術(S, M)
センチネルリンパ節生検(XXS, XS, S)

整形外科手術
人工肩関節置換術(オーソペディックプロテクター S/S, S/M)
人工股関節置換術(オーソペディックプロテクター S/M, M/L)

文献
“Our meta-analysis found that dual-ring wound protectors reduce the odds of SSI in patients undergoing lower
gastrointestinal surgery.”...

“We demonstrated evidence of a subgroup difference where dual-ring wound protectors reduced SSIs while single-ring
retractors did not, which provides greater insight in the choice of wound protection devices.”
Zhang L, Elsolh B, Patel SV. Wound protectors in reducing surgical site infections in lower gastrointestinal surgery: An updated metaanalysis. Surg Endosc. 2018;32(3):1111-1122. (Level of Evidence 1)“Among adult patients with intrabiliary stents, the use of a dual-ring wound protector during[pancreaticoduodenectomy] significantly reduces the risk of incisional SSI.”
Bressan AK, Aubin J-M, Martel G, et al. Efficacy of a dual-ring wound protector for prevention of surgical site infections afterpancreaticoduodenectomy in patients with intrabiliary stents: A randomized clinical trial. Ann Surg. 2018;268(1):35-40. (Level ofEvidence 1)“[T]he use of plastic-sheath wound retractors such as the Alexis® O C-Section Retractor compared to the traditional Collins
self-retaining metal retractor in low-risk women, having the first cesarean is associated with a significantly reduced risk ofsurgical site infection.”...

“There is significant reduction in the use of electric cautery for subcutaneous bleeding, bowel handling and postoperative
pain. Operator satisfaction is improved and postoperative pain is less.”
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 ofEvidence 1)“Impervious plastic wound protectors reduce the risk of SSI when employed in non-trauma-related gastrointestinal andbiliary tract surgery. Wound protectors represent a safe and simple intervention that may reduce postoperative morbidity
and mortality.”
Edwards JP, Ho AL, Tee MC, Dixon E, Ball CG. Wound protectors reduce surgical site infection: A meta-analysis of randomized controlled
trials. Ann Surg. 2012;256(1):53-59. (Level of Evidence 1)“Superficial incisional SSI was significantly diminished in the ALEXIS wound retractor group (P=0.006).”
Cheng KP, Roslani AC, Sehha N, et al. ALEXIS O-Ring wound retractor vs conventional wound protection for the prevention of surgicalsite infections in colorectal resections. Colorectal Dis. 2012;14(6):346-351. (Level of Evidence 1)“[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 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)

“These results suggest that the [wound protector] protects an incision site from bacterial invasion.”
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)“In this study the use of barrier wound protection in elective open colorectal resectional surgery resulted in a clinicallysignificant reduction in incisional surgical site infections.”...

“There was a significant reduction in the incidence of incisional surgical site infections when the wound protector wasused: 3 of 64 (4.7%) vs 15 of 66 (22.7%); P = .004.”
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)“Our data demonstrate that a statistically significant reduction in the incidence of wound infection was achieved with theuse 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, 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)“We found that the wound retractor/protector prevented the incision site from drying, decreased tissue damage, andfacilitated the migration of neutrophils, suggesting a preventive effect of the device with respect towound infection.”...

“The studied wound retractor/protector effectively protects wound tissue from damage due to environmental factors
experienced during surgery.”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)“Wound infection was significantly diminished in the With Alexis retractor group (p=0.0021).”
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)

Alexis O ウーンドプロテクター/リトラクター
広い術野確保のためのリジッドリング

製品番号

サイズ

シース長(cm)

切開長（cm） 販売単位

C8401*

S

162.5-65個/箱

C8402

M

165-95個/箱C8403

L

219-145個/箱

C8404

XL

3111-175個/箱

C8405

XXL

3117-255個/箱

Alexis ウーンドプロテクター/リトラクター
柔軟な適合性を備えたフレキシブルリング

製品番号

サイズ

シース長(cm)

切開長（cm） 販売単位

C8313*

XXS

171-35個/箱C8323*XXS ショート

81-35個/箱C8312*

XS

162-45個/箱C8322*

XS ショート102-45個/箱C8301*

S

162.5-65個/箱C8302

M

165-95個/箱C8303

L

219-145個/箱C8304

XL

3111-175個/箱

Alexis O C-セクション プロテクター/リトラクター
（帝王切開用)広い子宮露出のためのリジッドリング

製品番号

サイズ

シース長(cm)

切開長（cm） 販売単位

G6313

L

219-145個/箱G6314

XL

3111-175個/箱

Alexis ラパロスコピックシステム

組織回収前後の腹腔鏡的アプローチを可能にするラップキャップを付属

製品番号

サイズ

シース長(cm)

切開長（cm） 販売単位

C8501*

S

162.5-66個/箱

C8502

M

165-96個/箱＊使用後の取り外しを容易にするためのテザー付きの製品です。

Alexis オーソペディックプロテクター
広い術野確保のためのリジッドリングと柔軟な適合性を備えたフレキシブルリング

製品番号サイズシース長(cm)

切開長（cm） 販売単位

HR000

XS/M

102.5-75個/箱

HR001

S/S

102.5-85個/箱

HR004

S/M

102.5-85個/箱

HR005

M/L

145-135個/箱

リジッドリング

フレキシブルリング

HR100XS/M

102.5-75個/箱

HR101

S/S

102.5-85個/箱

HR104

S/M

102.5-85個/箱

HR105

M/L

145-135個/箱

1. 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 ColonRectum. 2010;53(10):1374-1380. (Level of Evidence 1)
2. 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)
3. 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. ArchSurg. 2009;144(9):872-875. (Level of Evidence 1)
4. 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)
5. 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)
6. 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)
7. Mohan HM, McDermott S, Fenelon L, et al; Members of the University College Dublin Wound Retractor Study Group. Plastic wound retractors as bacteriological barriers ingastrointestinal surgery: A prospective multi-institutional trial. J Hosp Infect. 2012;81(2):109-113. (Level of Evidence 2)
8. 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)
9. Spera P, Lloyd JD, Hernandez E, et al. AORN ergonomic tool 5: Tissue retraction in the perioperative setting. AORN J. 2011;94(1):54-58.

詳しくはhttps://appliedmedical.co.jp/Products/Alexisをご覧ください
販売名：Alexis・ウーンドプロテクター/リトラクター
医療機器製造販売認証番号：302ACBZX00028000
販売名：Alexis・オーソペディックプロテクター
医療機器製造販売認証番号：302ACBZX00029000★単回使用★添付文書を必ずお読みになってからご使用ください© 2022 Applied Medical Resources Corporation. All rights reserved.
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■製造販売元■製造業者

Applied Medical Japan株式会社

アプライドメディカル リソーサズ社 アメリカ合衆国〒101-0047

www.appliedmedical.com

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