{"id":741,"date":"2023-07-05T15:45:50","date_gmt":"2023-07-05T07:45:50","guid":{"rendered":"http:\/\/longmed-medical.com\/?p=741"},"modified":"2023-12-21T14:17:16","modified_gmt":"2023-12-21T06:17:16","slug":"zip-stitch-longmed-wound-closure-device","status":"publish","type":"post","link":"https:\/\/longmed-medical.com\/tr\/longmed-cilt-kapatma-cihaz-randomize-calisma\/","title":{"rendered":"Zip Stitch Longmed Yara Kapatma Cihaz\u0131 Randomize \u00c7al\u0131\u015fma"},"content":{"rendered":"
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Zip Stitch Longmed Yara Kapatma Cihaz\u0131 Randomize \u00c7al\u0131\u015fma<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t
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Konjenital Kalp Ameliyatlar\u0131ndan Sonra Kullan\u0131m \u0130\u00e7in Yeni Bir Noninvaziv Zip Stitch Cilt Kapatma Cihaz\u0131n\u0131n Randomize \u00c7al\u0131\u015fmas\u0131<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t
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Yuki Tanaka, MD, Takashi Miyamoto, MD, PhD, Yuji Naito, MD, PhD, <\/b><\/strong><\/p>

Shuichi Yoshitake, MD, Akihiro Sasahara, MD ve Kagami Miyaji, MD, PhD <\/b><\/strong><\/p>

Kardiyovask\u00fcler Cerrahi B\u00f6l\u00fcm\u00fc, Gunma \u00c7ocuk T\u0131p Merkezi, Shibukawa; ve Kalp ve Damar Cerrahisi Anabilim Dal\u0131,<\/p>

Kitasato \u00dcniversite Hastanesi, Sagamihara, Japonya<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t

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Arka plan:<\/p>

Yeni bir Zip Stitch Longmed noninvaziv rapor ediyoruz yara kapatma cihaz\u0131<\/a> (ZheJiang Longmed Medical Technology Co.,Ltd.,).Bu cihaz\u0131n ameliyatlardan sonra iyi kozmetik sonu\u00e7lar\u0131 oldu\u011fu kabul edilir ve ameliyat s\u00fcresini azalt\u0131r. Bu \u00e7al\u0131\u015fmada, Kapatma cihaz\u0131 kullan\u0131larak yap\u0131lan cilt kapatma, cilt alt\u0131 diki\u015flerle kar\u015f\u0131la\u015ft\u0131r\u0131lm\u0131\u015f ve bu yeni cihaz\u0131n kullan\u0131\u015fl\u0131l\u0131\u011f\u0131 ve g\u00fcvenli\u011fi de\u011ferlendirilmi\u015ftir.<\/p>

Y\u00f6ntemler\uff1a<\/p>

Bu, Haziran 2014 ile Aral\u0131k 2015 aras\u0131nda medyan sternotomi ile kalp ameliyat\u0131 ge\u00e7iren 214 hastan\u0131n yer ald\u0131\u011f\u0131 prospektif, randomize bir \u00e7al\u0131\u015fmayd\u0131. hastalara cilt alt\u0131 s\u00fct\u00fcr uyguland\u0131 (diki\u015f grubu). 78 hastada bu reoperasyon grubuydu, bunlar\u0131n 42'si Kapatma grubunda, 36's\u0131 s\u00fct\u00fcr grubundayd\u0131. Kozmetik sonu\u00e7lar birinci operasyon grubu ve reoperasyon grubunda ayr\u0131 ayr\u0131 Vancouver Skar Skalas\u0131 kullan\u0131larak de\u011ferlendirildi.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t

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Sonu\u00e7lar:<\/p>

Birinci ameliyat grubu (p < 0.001) ve yeniden ameliyat grubu (p [ 0.007) aras\u0131nda toplam Vancouver Skar Skalas\u0131 skorunda anlaml\u0131 farkl\u0131l\u0131klar vard\u0131. Cilt kapatma s\u00fcresi, Kapatma grubunda s\u00fct\u00fcr grubuna g\u00f6re anlaml\u0131 olarak daha k\u0131sayd\u0131 (113.0 \u00b1 9.1 saniye vs 375.9 \u00b1 60.2 saniye, p < 0.001). Gruplar aras\u0131nda cerrahi alan enfeksiyonu oran\u0131 a\u00e7\u0131s\u0131ndan anlaml\u0131 fark bulunmad\u0131. Bu cihaza \u00f6zg\u00fc komplikasyonlar ciltte renk de\u011fi\u015fikli\u011fini i\u00e7ermektedir.(0.9%), epidermoliz (0.9%) ve cihaz\u0131n pul pul d\u00f6k\u00fclmesi (1.8%); ancak ciddi bir komplikasyon geli\u015fmedi.<\/span><\/p>\n

<\/p>\n

Sonu\u00e7lar:<\/p>

Medyan sternotomi yoluyla yap\u0131lan do\u011fu\u015ftan kalp ameliyatlar\u0131nda, yara kapatma cihaz\u0131 bir kozmetik g\u00f6r\u00fcn\u00fcm\u00fc iyile\u015ftirmek ve yara kapanma s\u00fcresini azaltmak i\u00e7in m\u00fckemmel bir se\u00e7imdir. Ayr\u0131ca g\u00fcvenle kullan\u0131labilecek bir cihaz oldu\u011funu kan\u0131tlad\u0131.<\/span><\/p>\n

(Ann Thorac Surg 2016;102:1368\u201374) 2016, The Society of Thoracic Surgeons<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t

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Cerrahi alan enfeksiyonlar\u0131 ve hipertrofik skarlar, cerrahi sonras\u0131 en \u00f6nemli yara komplikasyonlar\u0131d\u0131r ve bunlar bazen kardiyovask\u00fcler operasyonlardan sonra ortaya \u00e7\u0131kabilir [1-3]. Siyanoakrilat yap\u0131\u015ft\u0131r\u0131c\u0131 ve cerrahi z\u0131mbalar gibi \u00e7e\u015fitli cilt kapatma cihazlar\u0131n\u0131n kullan\u0131m\u0131 bildirilmi\u015ftir [4-6] ve bu cihazlar\u0131n cilt kapatma s\u00fcresini k\u0131saltma, kozmetik g\u00f6r\u00fcn\u00fcm\u00fc iyile\u015ftirme ve enfeksiyon oran\u0131n\u0131 azaltma konusunda iyi bir potansiyele sahip oldu\u011fu g\u00f6sterilmi\u015ftir. . Yara kapama cihaz\u0131 (ZheJiang Longmed Medical Technology Co.,Ltd.), yara kapama potansiyelini azaltan yeni, noninvaziv bir son tabaka cilt kapatma cihaz\u0131d\u0131r.\u00a0yara komplikasyonlar\u0131 i\u00e7in [7, 8].<\/span><\/p>

Zip Stitch Longmed yara kapatma cihaz\u0131n\u0131n geli\u015ftirme konsepti, cilt kapatma s\u00fcresini k\u0131saltmak ve ameliyattan sonra hipertrofik bir yara izini \u00f6nlemekti. Kapatma cihaz\u0131n\u0131n Kardiyovask\u00fcler cerrahi d\u0131\u015f\u0131ndaki alanlarda kullan\u0131ld\u0131\u011f\u0131 bildirilmi\u015f olmas\u0131na ra\u011fmen, yara kapatma cihaz\u0131n\u0131n median sternotomi uygulanan do\u011fu\u015ftan hastalar\u0131n cerrahi yaralar\u0131n\u0131 kapatmak i\u00e7in kullan\u0131ld\u0131\u011f\u0131na dair herhangi bir rapor bulunmamaktad\u0131r. Bu \u00e7al\u0131\u015fmada, yara kapatma cihaz\u0131n\u0131n yaray\u0131 kapatmak i\u00e7in kullan\u0131\u015fl\u0131 ve g\u00fcvenli bir cihaz olup olmad\u0131\u011f\u0131n\u0131 de\u011ferlendirdik.\u00a0cerrahi kesikler<\/a> medyan sternotomi yoluyla kardiyovask\u00fcler operasyonlardan sonra konjenital hastalarda.<\/span><\/p>

\u00a0<\/p>

23 Mart 2016'da yay\u0131na kabul edilmi\u015ftir.<\/p>

Dr Tanaka, \u00c7ocuk Kalp Cerrahisi B\u00f6l\u00fcm\u00fc, Gunma \u00c7ocuk T\u0131p Merkezi, 779 Shimohakoda,Hokkitsumati, Shibukawa, Gunma 377-8577, Japonya; e-posta: tfjgp484@yahoo.co.jp.<\/span><\/p>

2016 The Society of Thoracic Surgeons 0003-4975\/$36.00 Yay\u0131nlayan Elsevier<\/span><\/p>

\u00a0<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t

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Hastalar ve Y\u00f6ntemler<\/p>

Bu yara kapatma cihaz\u0131 \u00e7al\u0131\u015fmas\u0131n\u0131n ara\u015ft\u0131rma protokol\u00fc, Helsinki Bildirgesi'ne uygun olarak kurumumuzdaki \u00c7al\u0131\u015fma \u0130nceleme Kurulu taraf\u0131ndan onayland\u0131.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t

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Hastalar ve \u00c7al\u0131\u015fma Tasar\u0131m\u0131<\/p>

Yara kapatma cihaz\u0131 \u00e7al\u0131\u015fmas\u0131, Haziran 2014'ten Ekim 2015'e kadar Japonya'n\u0131n Shibukawa kentindeki Gunma \u00c7ocuk T\u0131p Merkezi Kalp ve Damar Cerrahisi B\u00f6l\u00fcm\u00fc'nde medyan sternotomi yoluyla art arda kalp ameliyat\u0131 ge\u00e7iren 238 hastay\u0131 i\u00e7eriyordu. Kay\u0131tl\u0131 hastalar, bilgisayarl\u0131 basit randomizasyon kullan\u0131larak bir yara kapatma cihaz\u0131 grubuna (Kapatma grubu) veya subkutik\u00fcler s\u00fct\u00fcr grubuna (diki\u015f grubu) rastgele atand\u0131 ve bunlar \u00fczerinde \u00e7al\u0131\u015f\u0131ld\u0131.\u00a0ileriye d\u00f6n\u00fck olarak (\u015eekil 1). T\u00fcm hastalar kat\u0131lmak i\u00e7in yaz\u0131l\u0131 bilgilendirilmi\u015f onam verdi.<\/span><\/p>

Gecikmi\u015f sternum kapanmas\u0131 ge\u00e7irmi\u015f olan ve trizomi 21 d\u0131\u015f\u0131nda kromozomal anormalli\u011fi olan hastalar, bu denemedeki de\u011ferlendirmeyi basitle\u015ftirmek amac\u0131yla \u00e7al\u0131\u015fmadan \u00e7\u0131kar\u0131ld\u0131. Gecikmi\u015f sternum kapanmas\u0131 olan 20 hasta, trizomi 21 d\u0131\u015f\u0131nda kromozomal anormalli\u011fi olan 1 hasta ve operasyondan sonraki 3 ay i\u00e7inde \u00f6len 3 hasta \u00e7al\u0131\u015fma d\u0131\u015f\u0131 b\u0131rak\u0131ld\u0131 ve bu \u00e7al\u0131\u015fmada 214 hasta kald\u0131.Yeniden ameliyat edilen hastalar ve trizomi 21 hastalar\u0131 dahil edildi.<\/p>

Cinsiyet, ya\u015f, v\u00fccut a\u011f\u0131rl\u0131\u011f\u0131, hastan\u0131n Down sendromlu olup olmad\u0131\u011f\u0131, bebek veya yenido\u011fan olup olmad\u0131\u011f\u0131, cerrahi yaran\u0131n uzunlu\u011fu, toplam ameliyat s\u00fcresi ve kanama miktar\u0131n\u0131 i\u00e7eren demografik veriler ve klinik \u00f6zellikler topland\u0131. Bu \u00e7al\u0131\u015fmada analiz edilen sonu\u00e7lar aras\u0131nda kozmetik g\u00f6r\u00fcn\u00fcm, cilt kapanma s\u00fcresi ve komplikasyon oran\u0131 yer almaktad\u0131r.<\/p>

214 hasta ilk ameliyat (FO) grubuna veya yeniden ameliyat (RO) grubuna ayr\u0131ld\u0131 ve her grup kozmetik g\u00f6r\u00fcn\u00fcm a\u00e7\u0131s\u0131ndan analiz edildi. Ancak Kapatma grubu ile s\u00fct\u00fcr grubu aras\u0131ndaki cilt kapatma s\u00fcrelerini ve komplikasyon oranlar\u0131n\u0131 kar\u015f\u0131la\u015ft\u0131rmak i\u00e7in t\u00fcm hastalar bir araya getirildi. \u00d6nceden yara kapatma cihaz\u0131na \u00f6zg\u00fc cilt rengi de\u011fi\u015fikli\u011fi, epidermoliz, cihaza kar\u015f\u0131 alerjik reaksiyon gibi potansiyel komplikasyonlar\u0131 analiz ettik.<\/p>

cihaz\u0131n hasar g\u00f6rmesi ve pul pul d\u00f6k\u00fclmesi. Bu komplikasyonlar \u015firket taraf\u0131ndan sa\u011flanan bilgiler ve ki\u015fisel deneyimler temel al\u0131narak analiz edilmi\u015f ve cihaz\u0131n g\u00fcvenli\u011finin de\u011ferlendirilmesi amac\u0131yla cihazdaki hasarlar da dahil edilmi\u015ftir.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t

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Cihaz ve Teknik<\/p>\n

Bu \u00e7al\u0131\u015fmaya dahil edilen 214 hasta, kardiyopulmoner baypasl\u0131 veya baypass\u0131z medyan sternotomi ile kardiyovask\u00fcler ameliyat ge\u00e7irdi. Hem kapatma hem de s\u00fct\u00fcr gruplar\u0131nda cilt alt\u0131 dokular 4-0 Vicryl (Ethicon, Cincinnati,OH) emilebilir multifilament s\u00fct\u00fcrler kullan\u0131larak dikildi. Kapatma grubunda cerrahi yaran\u0131n en d\u0131\u015f y\u00fczeyi yara kapatma aparat\u0131 ile kapat\u0131ld\u0131 (\u015eekil 2). S\u00fct\u00fcr grubunda kontin\u00fc subk\u00fctik\u00fcler s\u00fct\u00fcrler konvansiyonel olarak 5-0 Prolene s\u00fct\u00fcrler (Ethicon) kullan\u0131larak cerrahi klips bir s\u00fct\u00fcr ucunda olacak \u015fekilde yerle\u015ftirildi.<\/span><\/p>\n

Ter veya ef\u00fczyonla lekelenmesi durumunda dezenfektans\u0131z yeni gazl\u0131 bez ile de\u011fi\u015ftirilen steril gazl\u0131 bez kullan\u0131larak yara korumas\u0131 sa\u011fland\u0131. T\u00fcm hastalarda operasyondan 7 g\u00fcn sonra cihaz\u0131n \u00e7\u0131kar\u0131lmas\u0131 veya diki\u015flerin al\u0131nmas\u0131 ger\u00e7ekle\u015fti. Yara kapatma cihaz\u0131n\u0131n \u00e7\u0131kar\u0131lmas\u0131, cildi korumak i\u00e7in bir adezyon giderici (Nichiban, Bunkyo, Tokyo, Japonya) kullan\u0131larak sa\u011fland\u0131. Cihaz veya diki\u015fler al\u0131nd\u0131ktan sonra hastalar\u0131n banyo yapmas\u0131na izin verildi.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t

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Takip ve Veri Toplama<\/p>

Elektronik t\u0131bbi kay\u0131tlar ve Japon konjenital kardiyovask\u00fcler cerrahi veri taban\u0131, klinik verileri kaydetmek i\u00e7in ara\u00e7lar olarak kullan\u0131ld\u0131. T\u00fcm demografik veriler ve klinik \u00f6zellikler verileri ameliyat \u00f6ncesi kaydedildi ve\u00a0intraoperatif olarak. Cilt kapanma s\u00fcreleri intraoperatif olarak kronometre ile kaydedildi. yara y\u00f6netimi\u00a0<\/span>protokol t\u00fcm hastalara uyguland\u0131. Takip ve komplikasyon verileri, ameliyattan 1, 2, 4, 8 ve 12 hafta sonra 3 kardiyovask\u00fcler cerrah taraf\u0131ndan topland\u0131. Kozmetik g\u00f6r\u00fcn\u00fcm ameliyattan 3 ay sonra kaydedildi. Hastalar taburcu olduktan sonra kurumumuzda ayaktan takip edildi.<\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t

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Yara De\u011ferlendirmesi<\/p>

Kozmetik sonu\u00e7lar\u0131n de\u011ferlendirilmesi, kullan\u0131lan cilt kapatma tipini bilmeyen 2 plastik cerrah taraf\u0131ndan operasyondan 3 ay sonra yap\u0131ld\u0131. Kozmetik g\u00f6r\u00fcn\u00fcm, ilk olarak 1990 y\u0131l\u0131nda Sullivan taraf\u0131ndan tan\u0131mlanan, yayg\u0131n olarak kabul g\u00f6ren bir yan\u0131k izi de\u011ferlendirme \u00f6l\u00e7e\u011fi olan Vancouver Skar Skalas\u0131 (VSS) kullan\u0131larak de\u011ferlendirildi. VSS, cerrahi skarlar i\u00e7in en s\u0131k kullan\u0131lan de\u011ferlendirme \u00f6l\u00e7e\u011fidir [9-11] ve d\u00f6rt taneden olu\u015fur vask\u00fclarite, pigmentasyon, esneklik ve y\u00fcksekli\u011fe dayal\u0131 kategoriler [12]. Toplam puan 0 ile 13 aras\u0131nda de\u011fi\u015fir, burada 0 puan\u0131 normal cildi yans\u0131t\u0131r (Tablo 1).<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t

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\u0130statistiksel Y\u00f6ntemler<\/p>

StatView 5.0 yaz\u0131l\u0131m\u0131 (SAS Institute Inc, Cary, NC) ve Excel 2013 (Microsoft Corp, Redmond, WA) kullan\u0131ld\u0131.\u00a0veri analizi. Sonu\u00e7lar, niceliksel de\u011fi\u015fkenler i\u00e7in aral\u0131klarda 95% g\u00fcven ile ortalama SD veya medyan ve \u00e7eyrekler aras\u0131 aral\u0131k olarak sunulur ve kategorik de\u011fi\u015fkenler mutlak frekanslar ve ya\u015f y\u00fczdeleri ile \u00f6zetlenir. S\u00fcrekli de\u011fi\u015fkenler \u00f6\u011frenci testi ve Mann-Whitney U testi kullan\u0131larak kar\u015f\u0131la\u015ft\u0131r\u0131ld\u0131. Kategorik de\u011fi\u015fkenler, beklenen frekanslar 5'ten k\u00fc\u00e7\u00fck oldu\u011funda Pearson X\u00b2 testi veya Fisher kesin testi kullan\u0131larak kar\u015f\u0131la\u015ft\u0131r\u0131ld\u0131. P de\u011ferlerinin 0,05 veya alt\u0131nda olmas\u0131 istatistiksel olarak anlaml\u0131 kabul edildi.<\/span><\/p>

\u00a0<\/p>

Sonu\u00e7lar<\/span><\/p>

FO grubunda 136 hasta (Kapatma grubu: 71 hasta; diki\u015f grubu: 65 hasta) ve RO grubunda 78 hasta (Kapatma grubu: 42 hasta; diki\u015f grubu: 36 hasta) vard\u0131. Poliklinik b\u00f6l\u00fcm\u00fcm\u00fcz 3'ten fazla hastay\u0131 takip etti. kalp ameliyat\u0131ndan aylar sonra. Demografik verilerin ve klinik \u00f6zelliklerin analizi, hi\u00e7bir\u00a0grup ve s\u00fct\u00fcr grubu aras\u0131nda anlaml\u0131 farklar (Tablo 2). Ayr\u0131ca \u00f6nemli bir fark yoktu\u00a0<\/span>ameliyat \u00f6ncesi RO grubundaki toplam ortalama VSS skorlar\u0131nda (Kapan\u0131\u015f: VSS 3,2 1,2; s\u00fct\u00fcr:VSS 3,3 1,3; p = 0,57). Ortalama ya\u015f ve v\u00fccut a\u011f\u0131rl\u0131\u011f\u0131 RO grubunda FO grubuna g\u00f6re daha y\u00fcksekti ve ortalama toplam ameliyat s\u00fcresi RO grubunda anlaml\u0131 olmamakla birlikte daha uzundu.<\/span><\/p>

\u00a0<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t

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Kozmetik G\u00f6r\u00fcn\u00fcm<\/p>

Kozmetik g\u00f6r\u00fcn\u00fcm ameliyattan 3 ay sonra VSS ile de\u011ferlendirildi (\u015eekil 3). FO grubunda Kapatma grubunun VSS'si t\u00fcm VSS de\u011fi\u015fkenleri i\u00e7in s\u00fct\u00fcr grubuna g\u00f6re anlaml\u0131 derecede d\u00fc\u015f\u00fckt\u00fc (Tablo 3). RO grubunda vask\u00fclarite, pigmentasyon ve toplam VSS skoru Kapatma grubunda s\u00fct\u00fcr grubuna g\u00f6re anlaml\u0131 olarak daha d\u00fc\u015f\u00fckt\u00fc. Ayr\u0131ca trizomi 21 hastalar\u0131nda total VSS skoru Kapatma grubunda s\u00fct\u00fcr grubuna g\u00f6re anlaml\u0131 olarak daha d\u00fc\u015f\u00fckt\u00fc (Tablo4). Ayr\u0131ca bebeklerde total VSS skoru Kapatma grubunda s\u00fct\u00fcr grubuna g\u00f6re anlaml\u0131 olarak daha d\u00fc\u015f\u00fckt\u00fc (Tablo 4). 5). Benzer \u015fekilde, yenido\u011fanlarda Kapatma grubunun toplam VSS skoru, s\u00fct\u00fcr grubundan \u00f6nemli \u00f6l\u00e7\u00fcde daha d\u00fc\u015f\u00fckt\u00fc (3,0 \u00b1 2,0 - 5,2 \u00b7 2,3, p < 0,017). 2 cerrah aras\u0131nda yara kapatma (p= 0.96) ve s\u00fct\u00fcr (p= 0.79) i\u00e7in VSS skorlar\u0131nda anlaml\u0131 fark yoktu.<\/p>

\u00a0<\/p>

Yara Kapatma Cihaz\u0131 Cilt Kapanma S\u00fcresi<\/p>

Kapatma grubu ile s\u00fct\u00fcr grubu aras\u0131ndaki toplam ameliyat s\u00fcresi fark\u0131 (340,3 127,1 dakika vs 328,2 120,7 dakika) anlaml\u0131 de\u011fildi (p= 0,70). Ancak, kapatma grubundaki cilt kapatma s\u00fcresi anlaml\u0131 olarak daha k\u0131sayd\u0131. s\u00fct\u00fcr grubu (113,0 9,1 saniye vs 375,9 60,2 saniye, p <0,001; \u015eekil 4). Medyan cilt kapatma s\u00fcreleri Kapatma grubunda 113 saniye (98-135 saniye) ve s\u00fct\u00fcr grubunda 389 saniye (256-470 saniye) idi.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t

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Komplikasyonlar ve Fiziksel Bulgular<\/p>

Komplikasyon oran\u0131 Kapatma grubu (n= 113) ile s\u00fct\u00fcr grubu (n= 101) aras\u0131nda kar\u015f\u0131la\u015ft\u0131r\u0131ld\u0131. Kapatma grubunda 1 hastada, s\u00fct\u00fcr grubunda 2 hastada cerrahi yara enfeksiyonu geli\u015fti. Kapatma grubu ile s\u00fct\u00fcr grubu aras\u0131nda cerrahi enfeksiyon oran\u0131 anlaml\u0131 olarak farkl\u0131 de\u011fildi (0.9%'ye kar\u015f\u0131 2.0%, p= 0.50). \u00dc\u00e7 hastada ciddi olmayan cerrahi alan enfeksiyonu vard\u0131 ve bunlar antibiyotik ve tuzlu suyla y\u0131kama ile d\u00fczeldi. Kapatma grubunda 2 hastada, s\u00fct\u00fcr grubunda 3 hastada cerrahi yara a\u00e7\u0131lmas\u0131 meydana geldi. \u0130ki grup aras\u0131nda cerrahi yara ayr\u0131lmas\u0131nda anlaml\u0131 bir fark yoktu (1.8%'ye kar\u015f\u0131 3.0%, p = 0.56). Yara ayr\u0131lmas\u0131 meydana gelen t\u00fcm hastalar yenido\u011fan veya trizomi 21'li idi. Kapatma cihaz\u0131na \u00f6zg\u00fc meydana gelen komplikasyonlar aras\u0131nda ciltte renk de\u011fi\u015fikli\u011fi (0.9%), epidermolizis (0.9%) ve cihaz\u0131n pul pul d\u00f6k\u00fclmesi (1.8%) vard\u0131. Yap\u0131\u015fkan band\u0131n patlamas\u0131 nedeniyle renk de\u011fi\u015fikli\u011fi meydana geldi ve bu, steroid merhem uygulanmas\u0131yla d\u00fczeldi. Epidermoliz ayr\u0131ca merhem ile tedavi edildi. Cihazlar\u0131 soyulan hastalara yeni cihazlar yap\u0131\u015ft\u0131r\u0131ld\u0131.<\/p>

Ancak, cihazlara alerji veya hasar gibi ciddi bir komplikasyon geli\u015fmedi. Bebekleri de i\u00e7eren pediatrik hastalar\u0131m\u0131z bu semptomlardan \u015fikayet\u00e7i olamad\u0131\u011f\u0131ndan ka\u015f\u0131nt\u0131 veya a\u011fr\u0131y\u0131 de\u011ferlendiremedik.<\/p>

Bununla birlikte, yara kapatma cihaz\u0131n\u0131n veya diki\u015flerin al\u0131nmas\u0131 s\u0131ras\u0131nda, Diki\u015f grubuna k\u0131yasla Kapatma grubunda \u00f6nemli \u00f6l\u00e7\u00fcde daha az hasta a\u011flad\u0131 veya \u015fikayet etti (7,1% vs 52,5%, p < 0,001).<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t

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Yorum
Bu \u00e7al\u0131\u015fma, kalp ameliyat\u0131 ge\u00e7iren pediatrik hastalarda yara kapatma cihaz\u0131n\u0131n ilk randomize kontroll\u00fc \u00e7al\u0131\u015fmas\u0131d\u0131r. Yara kapatma cihaz\u0131yla ilgili baz\u0131 yeni vaka raporlar\u0131 sunulmas\u0131na ra\u011fmen, hi\u00e7biri median sternotomi ile kardiyak operasyon bildirmedi [7, 8]. Ayr\u0131ca, pediatrik hastalardaki faydalar veya komplikasyon riskleri bilinmemektedir. \u00c7al\u0131\u015fmam\u0131zda medyan sternotomi ile kalp ameliyat\u0131 ge\u00e7irmi\u015f \u00e7ocuk hastalar\u0131 de\u011ferlendirdik. Sonu\u00e7lar\u0131m\u0131z, diki\u015f grubuna k\u0131yasla Kapatma grubunda \u00f6nemli \u00f6l\u00e7\u00fcde daha iyi bir sonu\u00e7 g\u00f6sterdi. Elektrokoter kullan\u0131m\u0131, enfeksiyon, yakla\u015f\u0131m ve diki\u015f materyali gibi cerrahi yaralar\u0131n kozmetik g\u00f6r\u00fcn\u00fcm\u00fcn\u00fc etkileyen bir dizi fakt\u00f6r g\u00f6z \u00f6n\u00fcne al\u0131nd\u0131\u011f\u0131nda [13-15] , tutarl\u0131 bir cerrahi insizyonel yakla\u015f\u0131m ve s\u00fct\u00fcr materyali kulland\u0131k ve t\u00fcm hastalarda median sternotomi yapmak i\u00e7in elektrokoter kullan\u0131ld\u0131. Sonu\u00e7lar\u0131m\u0131z, yara kapatma cihaz\u0131n\u0131n, ister ilk ameliyat, ister tekrar ameliyat olsun, kozmetik yararlar\u0131 oldu\u011funu g\u00f6sterdi. Pediatrik kalp cerrahisinde bir\u00e7ok hastada trizomi 21 vard\u0131r [16]. Ayr\u0131ca, kardiyak defektleri olan pediatrik hastalarda kalp ameliyatlar\u0131 s\u0131kl\u0131kla bebeklik d\u00f6neminde uygulanmaktad\u0131r [17, 18].<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t

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Bu \u00e7al\u0131\u015fman\u0131n sonu\u00e7lar\u0131na dayanarak, bu yara kapatma cihaz\u0131n\u0131n geni\u015f bir hasta yelpazesinde ba\u015far\u0131yla kullan\u0131labilece\u011fine inan\u0131yoruz.
Kapatma s\u00fcresi a\u00e7\u0131s\u0131ndan, yara kapatma cihaz\u0131 kullan\u0131larak kapat\u0131lan cerrahi yaralar, diki\u015f kullan\u0131larak kapat\u0131lan yaraya k\u0131yasla a\u00e7\u0131k\u00e7a m\u00fckemmel bir performansa sahipti. Benzer \u015fekilde, 2-oktilsiyanoakrilat yap\u0131\u015ft\u0131r\u0131c\u0131n\u0131n kullan\u0131m\u0131 da cerrahi yara kapanma s\u00fcresini azaltabilir [4, 19]. Bununla birlikte, medyan sternotomi i\u00e7in oktilsiyanoakrilat kullan\u0131ld\u0131\u011f\u0131na dair hi\u00e7bir rapor yoktur, bu da g\u00fcvenli\u011finin ve kapanma s\u00fcrelerinin yara kapatma cihaz\u0131yla kar\u015f\u0131la\u015ft\u0131r\u0131lmas\u0131n\u0131 zorla\u015ft\u0131r\u0131r. Bu \u00e7al\u0131\u015fmada,
Kapatma grubunda cilt kapatma s\u00fcresinin zamansal da\u011f\u0131l\u0131m\u0131 son derece k\u00fc\u00e7\u00fckt\u00fc, bu da bu cihaz\u0131n kullan\u0131m\u0131n\u0131n yaran\u0131n uzunlu\u011fundan veya farkl\u0131 cerrahlardan etkilenmedi\u011fi anlam\u0131na geliyor. Bu nedenle, yara ne kadar uzun olursa, o kadar b\u00fcy\u00fck nispi fayda beklenebilir.
Kapatma grubu ile s\u00fct\u00fcr grubu aras\u0131nda cerrahi yara enfeksiyonu oran\u0131 a\u00e7\u0131s\u0131ndan fark anlaml\u0131 olmasa da Kapatma grubunda daha az yara enfeksiyonu meydana geldi. Pediatrik kalp operasyonlar\u0131ndan sonra cerrahi alan enfeksiyonu insidans\u0131n\u0131n 2.3% ile 8% aras\u0131nda de\u011fi\u015fti\u011fi rapor edilmi\u015ftir [20-23]. Bu \u00e7al\u0131\u015fmada Kapatma grubunda ameliyat sonras\u0131 yara enfeksiyonu insidans\u0131 0,9% olarak hesaplanm\u0131\u015f olup, Kapatma grubunda epidermiste herhangi bir kal\u0131nt\u0131 olmad\u0131\u011f\u0131 g\u00f6z \u00f6n\u00fcne al\u0131nd\u0131\u011f\u0131nda bu son derece d\u00fc\u015f\u00fck bir enfeksiyon oran\u0131d\u0131r. Cerrahi yara enfeksiyonlar\u0131n\u0131 \u00f6nlemek i\u00e7in silikon jel kullan\u0131m\u0131 veya hipertrofik skarlar sunulmu\u015ftur [24-26]. Bununla birlikte, yara kapatma cihaz\u0131n\u0131n yara kapanma s\u00fcresini k\u0131saltma gibi ek bir faydas\u0131 vard\u0131r.
cerrahi yara enfeksiyonlar\u0131n\u0131 ve cerrahi izleri \u00f6nlemenin yan\u0131 s\u0131ra.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t

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Yara enfeksiyon oran\u0131na benzer \u015fekilde, Z grubundaki cerrahi yara ayr\u0131lma insidans oran\u0131, diki\u015f grubuna e\u015fit veya daha y\u00fcksekti. Bununla birlikte, yara kapatma cihaz\u0131, yaran\u0131n a\u00e7\u0131lmas\u0131 i\u00e7in daha fazla esnekli\u011fe sahiptir ve daha invazif de\u011fildir. Operasyondan 7 g\u00fcn sonra \u00e7al\u0131\u015fma tasar\u0131m\u0131na uygun olarak s\u00fct\u00fcr veya aparat\u0131 \u00e7\u0131kard\u0131k. Ancak yenido\u011fanlarda ve trizomi 21'li hastalarda yaran\u0131n durumuna g\u00f6re cihaz\u0131n \u00e7\u0131kart\u0131lmas\u0131 gerekti\u011fini d\u00fc\u015f\u00fcn\u00fcyoruz \u00e7\u00fcnk\u00fc sadece bu hastalarda yara ayr\u0131\u015fmas\u0131 g\u00f6zlendi. Cihaza \u00f6zg\u00fc komplikasyonlar, hi\u00e7biri y\u00fcksek oranda meydana gelmemesine veya ciddi olmamas\u0131na ra\u011fmen, ciltte renk de\u011fi\u015fikli\u011fi, epidermoliz ve cihaz\u0131n pul pul d\u00f6k\u00fclmesini i\u00e7erir. Sonu\u00e7 olarak yara kapatma aparat\u0131n\u0131n g\u00fcvenle kullan\u0131labilece\u011fi kan\u0131s\u0131na vard\u0131k.
Yara kapatma aparat\u0131n\u0131n \u00fcst\u00fcn bir \u00f6zelli\u011fi, uzunlu\u011funu ve gerginli\u011fini ayarlayabilmesidir. Cihaz\u0131n boyu uygun noktadan kesilerek kolayca ayarlanabilir. Adapt\u00f6rl\u00fc strap-rock sistemi sayesinde cihaz\u0131n gerginli\u011fi s\u0131n\u0131rs\u0131z olarak ayarlanabilmektedir. \u00d6rne\u011fin operasyon sonras\u0131 olu\u015fan \u00f6demin veya yara iyile\u015fmesinin derecesine g\u00f6re cihaz\u0131n tansiyonu birden \u00e7ok kez ayarlanabilmektedir. Dahas\u0131, fermuarlar\u0131n ba\u011flant\u0131s\u0131 kesilerek yaran\u0131n iyile\u015fme derecesi do\u011frulanabilir. B\u00f6ylece cihaz diki\u015fe gerek kalmadan fermuar\u0131 tekrar sallayarak ayr\u0131lmay\u0131 kar\u015f\u0131layabilir.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t

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Bu \u00e7al\u0131\u015fman\u0131n sonu\u00e7lar\u0131ndan, yara kapatma cihaz\u0131 kullanman\u0131n en b\u00fcy\u00fck avantajlar\u0131n\u0131n iyi kozmetik g\u00f6r\u00fcn\u00fcm ve azalt\u0131lm\u0131\u015f kapatma s\u00fcresi oldu\u011funa inan\u0131yoruz. Ayr\u0131ca cihaz\u0131n g\u00fcvenli\u011fi deri alt\u0131 diki\u015fler kadar iyiydi. Bununla birlikte, yara kapatma cihaz\u0131n\u0131n ay\u0131rt edici bir \u00f6zelli\u011fi, \u00e7\u0131kar\u0131ld\u0131\u011f\u0131nda daha az a\u011fr\u0131l\u0131 olmas\u0131yd\u0131, bu da onu \u00f6zellikle pediatrik hastalar i\u00e7in faydal\u0131 k\u0131l\u0131yordu. Asl\u0131nda, diki\u015f grubuna k\u0131yasla Kapatma grubunda \u00f6nemli \u00f6l\u00e7\u00fcde daha az hasta, cihaz\u0131n veya diki\u015flerin \u00e7\u0131kar\u0131lmas\u0131 s\u0131ras\u0131nda a\u011fr\u0131 veya a\u011flama ya\u015fad\u0131. Tersine, yara kapatma cihaz\u0131n\u0131n maliyet performans\u0131 diki\u015fler kadar iyi de\u011fil. Yara kapatma cihaz\u0131n\u0131n maliyeti $85'tir, bu da deri alt\u0131 s\u00fct\u00fcre g\u00f6re yakla\u015f\u0131k \u00fc\u00e7 kat daha fazlad\u0131r. Ancak kozmetik ve kapatma s\u00fcresi etkinli\u011fi a\u00e7\u0131s\u0131ndan bu cihaz\u0131n kullan\u0131lmaya de\u011fer oldu\u011funu d\u00fc\u015f\u00fcn\u00fcyoruz.<\/p>

Bu \u00e7al\u0131\u015fman\u0131n birka\u00e7 s\u0131n\u0131rlamas\u0131 vard\u0131r. \u0130lk olarak bu \u00e7al\u0131\u015fma tek bir kurumda yap\u0131lm\u0131\u015ft\u0131r; bu nedenle, sonu\u00e7lar\u0131m\u0131z\u0131n genelle\u015ftirilmesi s\u0131n\u0131rl\u0131d\u0131r. Bununla birlikte, bu veriler \u00f6nemlidir \u00e7\u00fcnk\u00fc bu, yara kapama cihaz\u0131n\u0131n amedian sternotomi uygulanan pediyatrik hastalarda kullan\u0131m\u0131n\u0131 bildiren ilk prospektif randomize \u00e7al\u0131\u015fmad\u0131r.<\/p>

\u0130kinci olarak, Down sendromlu hastalar\u0131n say\u0131s\u0131 nispeten azd\u0131r ve bu da cihaz\u0131n Down sendromlu pop\u00fclasyondaki etkinli\u011fini de\u011ferlendirmek i\u00e7in istatistiksel g\u00fcc\u00fcn yetersiz kalmas\u0131na neden olur.<\/p>

\u00dc\u00e7\u00fcnc\u00fcs\u00fc, \u00e7al\u0131\u015fma, trizomi 21 d\u0131\u015f\u0131nda kromozomal anormalli\u011fi olan hastalar\u0131 ve gecikmi\u015f sternal kapanmas\u0131 olan hastalar\u0131 d\u0131\u015flad\u0131. Bu nedenle, bu pop\u00fclasyonlardaki sonu\u00e7lar\u0131 inceleyemedik. Alet ve teknikle ilgili olarak, emilmeyen polipropilen s\u00fct\u00fcrler kullan\u0131larak diki\u015flerin \u00e7\u0131kar\u0131lmas\u0131yla s\u00fcrekli subk\u00fctik\u00fcler diki\u015f nadir bir y\u00f6ntem olabilir. Son olarak, bu \u00e7al\u0131\u015fma pediatrik hastalarda randomize bir \u00e7al\u0131\u015fmayd\u0131 ve yeti\u015fkin hastalarda etkinli\u011fini incelemedik. Bu nedenle, cihaz\u0131n yeti\u015fkin pop\u00fclasyonda kullan\u0131m\u0131n\u0131 do\u011frulamak i\u00e7in yeti\u015fkin hastalarda prospektif, randomize bir klinik \u00e7al\u0131\u015fma gereklidir.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t

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Sonu\u00e7 olarak bu, medyan sternotomi ile kalp ameliyat\u0131 ge\u00e7iren pediatrik hastalarda fermuarl\u0131 diki\u015f Longmed yara kapatma cihaz\u0131n\u0131n sonu\u00e7lar\u0131n\u0131 de\u011ferlendiren ilk randomize \u00e7al\u0131\u015fmad\u0131r. \u00c7al\u0131\u015fmam\u0131z, cihaz\u0131n kozmetik g\u00f6r\u00fcn\u00fcm\u00fc iyile\u015ftirmede ve cilt kapanma s\u00fcrelerini azaltmada m\u00fckemmel bir performansa sahip oldu\u011funu g\u00f6sterdi. Basit ve g\u00fcvenli bir \u015fekilde kullan\u0131labilen invaziv olmayan bir cihazd\u0131r ve daha az a\u011fr\u0131l\u0131 oldu\u011fu i\u00e7in pediatrik hastalar i\u00e7in uygun olabilir.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t

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              Zip Stitch Longmed Yara Kapatma Cihaz\u0131 Randomize \u00c7al\u0131\u015fma Konjenital Kalp Ameliyatlar\u0131ndan Sonra Kullan\u0131ma Y\u00f6nelik Yeni Noninvazif Zip Stitch Cilt Kapatma Cihaz\u0131n\u0131n Randomize \u00c7al\u0131\u015fmas\u0131 Yuki Tanaka, MD, Takashi Miyamoto, MD, PhD, Yuji Naito, MD, PhD, Shuichi Yoshitake, MD, Akihiro Sasahara, MD ve Kagami Miyaji, MD, Doktora Kalp Damar Cerrahisi B\u00f6l\u00fcm\u00fc, Gunma \u00c7ocuk T\u0131p Merkezi,\u2026<\/p>","protected":false},"author":1,"featured_media":689,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"elementor_header_footer","format":"standard","meta":{"_kad_post_transparent":"","_kad_post_title":"","_kad_post_layout":"","_kad_post_sidebar_id":"","_kad_post_content_style":"","_kad_post_vertical_padding":"","_kad_post_feature":"","_kad_post_feature_position":"","_kad_post_header":false,"_kad_post_footer":false,"footnotes":""},"categories":[2],"tags":[41,10,19,28],"class_list":["post-741","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-blog","tag-longmed-skin-closure-device","tag-wound-closure-device","tag-wound-closure-strips-longmed-zip-stitch-emergency-laceration-closures","tag-zip-stitch"],"_links":{"self":[{"href":"https:\/\/longmed-medical.com\/tr\/wp-json\/wp\/v2\/posts\/741","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/longmed-medical.com\/tr\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/longmed-medical.com\/tr\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/longmed-medical.com\/tr\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/longmed-medical.com\/tr\/wp-json\/wp\/v2\/comments?post=741"}],"version-history":[{"count":0,"href":"https:\/\/longmed-medical.com\/tr\/wp-json\/wp\/v2\/posts\/741\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/longmed-medical.com\/tr\/wp-json\/wp\/v2\/media\/689"}],"wp:attachment":[{"href":"https:\/\/longmed-medical.com\/tr\/wp-json\/wp\/v2\/media?parent=741"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/longmed-medical.com\/tr\/wp-json\/wp\/v2\/categories?post=741"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/longmed-medical.com\/tr\/wp-json\/wp\/v2\/tags?post=741"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}