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文献 Alexis ウーンドリトラクターの使用が下記文献で推奨されています “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).” “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. 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. “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.” “Superficial incisional SSI was significantly diminished in the ALEXIS wound retractor group (P=0.006).” ... 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. “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).” ... 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.” ... 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. “The studied wound retractor/protector effectively protects wound tissue from damage due to environmental factors experienced during surgery.” Nassif G., et al. Wound Infection After Colorectal Surgery In The Laparoscopic Era. SAGES Poster Session 2012. 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.” ... “Only the use of a wound protector was found to significantly reduce the risk of wound infections in an adjusted analysis.” “It was suggested that the use of the Alexis wound retractor would protect surgical wounds from contamination by bacteria and thus prevent infection.” 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. 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. “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. Wound Protectors/Retractors “The wound infection rate of the [left upper quadrant] trocar site was significantly decreased when utilizing the wound retractor (18% to 0%).” “[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.” “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%.” Alexis® 360° の創部保護 360° の低侵襲な開創 Visit www.stopwoundinfection.com to learn more about surgical site infection prevention. • 最小の切開サイズで、最大の開創を提供 • 多様な手技に対応 IS ALEXIS® PART OF YOUR STANDARD OF CARE? Alexis O ウーンドリトラクター BRAND 製品番号 サイズおよび対応切開長 販売単位 より広い術野確保のためのハードタイプリングが特徴 C8401 C8402 C8403 C8404 C8405 S M L XL XXL 2.5-6cm 5-9cm 9-14cm 11-17cm 17-25cm 1箱 (5個入) 1箱 (5個入) 1箱 (5個入) 1箱 (5個入) 1箱 (5個入) 術式適用例 表層切開創の感染率 Alexis ウーンドリトラクター 22.7% 標準開創器 (15/66) P = 0.004 79% RRR* 14.6% (7/48) 4.69% (3/64) Reid, et al. 1 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) 8.1% 100% サイズと対応切開長 販売単位 C8313 C8323 C8312 C8322 C8301 C8302 C8303 C8304 XXS XXS ショート XS XS ショート S M L XL 1箱(5個入) 1箱(5個入) 1箱(5個入) 1箱(5個入) 1箱(5個入) 1箱(5個入) 1箱(5個入) 1箱(5個入) 1-3cm 1-3cm 2-4cm 2-4cm 2.5-6cm 5-9cm 9-14cm 11-17cm RRR* (9/110) 0% (1/61) Lee, et al. 2 製品番号 最大の適応力をもつソフトタイプリングが特徴 乳腺腫瘤摘出術 (XS, S) 乳房切除術 (S, M) センチネルリンパ節生検 (XXS, XS, S) P = 0.0021 89% 1.6% 脾臓摘出術(L, XL) 膵腫瘍切除(L, XL) 肝切除術(XL, XXL) 乳腺手術 P = 0.02 RRR* Alexis ウーンドリトラクター 一般外科手術 (0/111) Horiuchi, et al. 3 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. Alexis ラパロスコッピックシステム 産婦人科手術 分娩後卵管結紮術(XXS, XS) 両側卵管卵巣摘出術(XS, S) 腹腔鏡下子宮摘出術 (S, M ラパロスコ ピックシステム) 小開腹術(S, M) 子宮筋腫摘出(核出)術(S, M) 腹式子宮全摘術(S, M, L) 帝王切開術(L, XL) 製品番号 サイズ対応切開長 販売単位 C8501 C8502 S M 1箱(6個入) 1箱(6個入) 2.5-6cm 5-9cm *RRR(相対危険度減少)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プロテクター)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。 360° の創部保護 · 創部の湿潤を維持します。 肥満手術 腹腔鏡下袖状胃切除術(XXS) 腹腔鏡下胃バイパス術(XS, S) 胃バイパス術(L, XL) · 創縁部の確認が可能です。 360° の低侵襲の円形開創を提供 · 力が均等に分散され、最適な術野を提供します。 · 最小の切開サイズで、最大の開創を提供します。 結腸および直腸手術 人工肛門造設術(XXS) 腹腔鏡下結腸切除術(S, M ラパロスコ ピックシステム) 結腸切除術(L, XL, XXL) 直腸切除術(L, XL, XXL) · 局所的外傷を軽減しながら、 より円形に近い開創を提供します。 多様な手技に対応 · 多様なサイズ展開で、様々な手技に対応します。 · 迅速、簡単なセットアップが可能な独自の設計です。 Alexis O C-セクションリトラクター (帝王切開用) 製品番号 サイズおよび対応切開長 販売単位 G6313 G6314 L XL 1箱(5個入) 1箱(5個入) 9-14cm 11-17cm ■製造販売元 販売名:Alexis ウーンド リトラクター 医療機器製造販売認証番号:223ACBZX00085000 心胸郭手術 胸腔鏡下手術(XXS, XS, S) 僧房弁修復/置換術(S, M) 開胸術(S, M) ◆本社・東京営業所 〒113-0034 東京都文京区湯島4-2-1 杏林ビル5F ★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 TEL: 03-5803-9271 FAX: 03-5803-9275 http://www.leaders.co.jp © 2015 Applied Medical Resources Corporation. 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