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Microdacyn® – antybakteryjny roztwór do oczyszczania i irygacji ran

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Microdacyn® to wodny roztwór oksydantów (super-oxidized solution) o działaniu antybakteryjnym. Wspomaga oczyszczanie autolityczne rany z martwicy oraz stwarza optymalne środowisko gojenia.

Jak działa produkt Microdacyn®?

Microdacyn® to roztwór ponadtlenków o udowodnionej skuteczności przeciwdrobnoustrojowej. Skład roztworu oparty jest na naturalnie występujących substancjach, takich jak kwas podchlorawy (HOCl), który jest odpowiedzialny za niszczenie błon komórkowych bakterii. Dzięki temu roztwór zwalcza mikroorganizmy na drodze naturalnych mechanizmów odpornościowych (fagocytoza). Szeroko zakrojone badania pokazały, iż Microdacyn® skutecznie zwalcza bakterie Gram-dodatnie i Gram-ujemne, w tym szczepy oporne takie jak VRE i MRSA, a także grzyby i wirusy.

Dzięki optymalnemu stężeniu substancji aktywnych roztwór nie ma działania cytotoksycznego wobec zdrowych tkanek. Roztwór Microdacyn® jest ponadto hipoalergiczny i charakteryzuje się obojętnym odczynem pH, dzięki czemu nie wywołuje reakcji alergicznych ani podrażnień. Zapewnia również bezpieczeństwo stosowania w obrębie gałki ocznej i jamy ustnej (w leczeniu pacjentów z zapaleniem błony śluzowej jamy ustnej w trakcie chemioterapii).

Roztwór wykazuje właściwości przeciwzapalne. Badania in-vitro wykazały, że 15-minutowa ekspozycja na roztwór ponadtlenkowy powoduje 90-procentową redukcję wydzielania histaminy przez mastocyty. Microdacyn® spowalnia uwalnianie cytokin prozapalnych, co umożliwia wzrost aktywności cytokin przeciwzapalnych inicjujących procesy gojenia.

W licznych kontrolowanych i randomizowanych badaniach wykazano, iż w badanych przypadkach u 90% pacjentów w wyniku stosowania roztworu doszło do wyraźnego wzrostu poziomu granulacji i poprawy otaczającej skóry, jak również efektywnej redukcji biofilmu bakteryjnego (Pseudomonas aeruginosa, E. coli). Dodatkowo wykazano, iż regularne stosowanie roztworu pozwala zapobiec ponownemu namnażaniu się mikroorganizmów. Microdacyn® nie powoduje wykształcenia oporności bakteryjnej.

Microdacyn® wpływa również na wzrost ilości dostępnego tlenu TcPO2 (mmHg). Wskazują na to wyniki badań, w których obserwowano średni poziom natlenienia tkanki po zastosowaniu roztworu u 393 diabetyków insulinoniezależnych z owrzodzeniem podudzi. Poziom dostępności TcPO2 natychmiast po zastosowaniu roztworu podnosił jakość tkanki w ranie i pozostawał na wysokim poziomie do 72 godzin. Dzięki zwiększaniu natlenienia tkanek Microdacyn® przyspiesza gojenie się ran.

Na jakie rany można stosować Microdacyn®?

Microdacyn® stosuje się do odkażania i płukania ran ostrych oraz przewlekłych, takich jak owrzodzenia goleni, owrzodzenia nowotworowe, odleżyny czy rany w przebiegu zespołu stopy cukrzycowej. Ponadto roztwór ten służy do oczyszczania ran oparzeniowych (termicznych, elektrycznych i chemicznych I i II stopnia) oraz odczynów popromiennych.

Stosuje się go również w pielęgnacji ran pooperacyjnych oraz miejsc wprowadzenia cewników urologicznych, gastrostomii, drenów oraz stomii. Jest również odpowiedni do stosowania w ranach bez możliwości drenażu.

Dzięki wysokiej biozgodności Microdacyn® jest produktem pierwszego wyboru do płukania jamy otrzewnej i śródpiersia, jamy brzusznej w leczeniu otwartego brzucha, drenowanych ropni jamy brzusznej, przestrzeni zaotrzewnowej i powłok, protez i łat naczyniowych, pęcherza moczowego oraz loży po stymulatorach serca. Może być stosowany do przepłukiwania ucha zewnętrznego, jamy ustnej, spojówki oka i błon śluzowych. Produkt jest także odpowiedni w przypadku ran z odsłoniętymi tkankami takimi jak więzadła i ścięgna.

Przeciwwskazania w stosowaniu

Stosowanie roztworu Microdacyn® nie jest wskazane u pacjentów z nadwrażliwością na składniki preparatu.

Opinia eksperta – prof. Axel Kramer, wybitny specjalista w dziedzinie leczenia ran

Wywiad pochodzi z listopada 2013 r., mowa jest w nim o produkcie Dermacyn®, który w marcu 2014 r. zmienił nazwę na Microdacyn® i pod taką nazwą występuje na rynku polskim.

Już w październiku na Kongresie D.A.CH. (Niemiecko-Austriacko-Szwajcarska Organizacja Leczenia Ran) w Friedrichshafen przedstawiono nowy roztwór do przemywania ran, który ma ustalać nowe normy w zakresie skuteczności i zgodności. Nasz rozmówca, prof. Axel Kramer z Uniwersytetu w Greifswaldzie, badał produkt pod względem zgodności i na podstawie literatury poddał zróżnicowanej ocenie.

RDG: Panie Profesorze, Dermacyn to w przyszłości kolejna w Niemczech oferta dotycząca roztworu do przemywania ran. Jakie znaczenie ma produkt w porównaniu z wyrobami bazującymi na octenidynie i poliheksanidzie?

Kramer: W badaniu laboratoryjnym Dermacyn osiąga taką samą skuteczność jak środki antyseptyczne na rany opierające się na octenidynie; w zależności od czynnika zakaźnego jest w chwili obecnej nawet skuteczniejszy niż poliheksanid. Należy podkreślić, że zwalcza nie tylko wirusy, grzyby i bakterie, ale także ich szczególnie oporne zarodniki. Jednak decydujące znaczenie dla stosowania na rany ma nie tylko skuteczność mikrobiocydalna, ale przede wszystkim tolerancja. Ona określa zasięg terapeutyczny – terapeuta porusza się przecież ustawicznie po wąskiej przestrzeni między efektywną redukcją mikrobów a możliwie najwyższą ochroną wrażliwej tkanki endogennej.

Tolerancję Dermacynu badaliśmy w szerokim zakresie, między innymi porównując na unaczynionej błonie biologicznej jaja kurzego, uznanym modelu do badań przesiewowych w celu ustalenia tolerancji ran. Okazało się, że Dermacyn jest wyraźnie lepiej tolerowany niż równolegle testowana octenidyna. Studia kliniczne doprowadziły do dalszego potwierdzenia doskonałej tolerancji Dermacynu.

W bezpośrednim klinicznym porównaniu Dermacyn okazał się lepszy tak od jodopowidonu, jak też od srebra jonowego w aspekcie czasu trwania leczenia ran i tolerancji. Znajduje to na przykład wyraz także w tym, że stosowanie octenidyny, poliheksanidu i jodopowidonu do płukania jamy brzusznej nie jest wskazane ze względu na nietolerancję tkanki, natomiast w przypadku Dermacynu w publikowanym badaniu nie wystąpiły żadne problemy. Oczywiście płukanie jamy brzusznej nie jest pierwszorzędowym wskazaniem do użycia Dermacynu, ale daje nam wskazówkę odnośnie doskonałej tolerancji, podobnie jak stosowanie na chrząstki i ścięgna.

RDG: Ze względu na rodzaj produktu Dermacyn uważany jest za „tlen w stadium powstawania“. W naszym kraju na takie produkty patrzy się krytycznie. Czy jest to usprawiedliwione?

Kramer: To rozumowanie powstało w przeszłości, a opiera się na nieporozumieniu. Dawniej do antyseptyki ran stosowano nadtlenek wodoru. Nadtlenek wodoru rzeczywiście jest cytotoksyczny w stężeniach, które są konieczne do skutecznego zwalczania bakterii. Natomiast Dermacyn nie zawiera nadtlenku wodoru. Jego głównymi składnikami są kwas podchlorawy i podchloryn sodu. Obie substancje nie mają nic wspólnego z nadtlenkiem wodoru!

Dermacyn bazuje na tej samej zasadzie działania i takich samych substancjach, jakie codziennie występują w naszych organizmach w procesie fagocytozy. Ponieważ nasze ciało wytworzyło właśnie taką, własną formę obrony przed zarazkami, dysponuje ono różnorakimi mechanizmami dla zapobiegania samouszkodzeniom. W przeciwnym razie, obrazowo mówiąc, każdego dnia samo by się zatruwało. Jednak właśnie do tego nie dochodzi, ponieważ – tu sformułowanie dla laików – dana jest „odporność” na kwas podchlorawy i podchloryn sodu, dlatego substancje biologicznie czynne z Dermacynu są tak doskonale tolerowane.

RDG: Dermacyn został dopuszczony jako produkt medyczny. Produktowi temu przypisuje się jednocześnie wysoki potencjał antyseptyczny; czy nie powinien zostać sklasyfikowany jako lek?

Kramer: Bądźmy szczerzy: 99% wspomagającego leczenie działania roztworów do płukania ran bazuje na czysto fizycznym usuwaniu zarazków chorobotwórczych, detrytu i innych pozostałości z ran. W tym względzie wszystkie roztwory do przemywania ran, o których mówimy, są do siebie podobne. Decydujące znaczenie ma jednak substancja biologicznie czynna zastosowana do stabilizacji roztworu do przemywania ran. Z pewnością możemy tu porównywać Dermacyn z produktami bazującymi na poliheksanidzie. Okazuje się przy tym, że właściwa ciału zasada odporności, taka jak ta, na której opiera się Dermacyn, jest nie tylko znacznie lepiej tolerowana, ale poza tym ma jeszcze ogromną zaletę, bo nie prowadzi do gromadzenia substancji czynnej w tkance. Poliheksanid jest substancją obcą dla organizmu, która ewentualnie przy dłuższym stosowaniu może się nawet nasycać. Substancje czynne Dermacynu po naniesieniu na ranę i zadziałaniu rozkładają się na sól kuchenną i wodę.

W jaki sposób używać produktu Microdacyn®?

Microdacyn® roztwór służy do stosowania zewnętrznego. Nie wymaga rozcieńczania.

W przypadku terapii ran należy nasączyć nim kompres gazowy i położyć go bezpośrednio na ranie. Zaleca się, aby czynność tę powtarzać dwa razy dziennie przez 15 minut, a także podczas każdej zmiany opatrunku. W celu zwiększenia skuteczności autolitycznego oczyszczania rany po przemyciu rany roztworem można dodatkowo zastosować  Microdacyn® w formie hydrożelu.

Preparat ten można również stosować zamiast soli fizjologicznej w celu przemycia ran pourazowych, ran oparzeniowych bądź silnie zanieczyszczonych. Roztwór nie wymaga wypłukiwania z ran głębokich.

Namoczenie rany roztworem Microdacyn® ułatwia również zmianę opatrunku w przypadku kiedy występuje problem z jego usunięciem.

Microdacyn® stosuje się również jako środek antyseptyczny do irygacji podczas zamykania ran po sternotomii. Po zamknięciu klatki piersiowej oraz wprowadzeniu pętli zespalających rany przez 15 minut namacza się roztworem. Po tej procedurze można wykonać rutynowe zamknięcie tkanki podskórnej oraz skóry.

Roztwór może być również stosowany do przedoperacyjnego płukania otrzewnej. W takim przypadku dreny zamykane są na godzinę po wprowadzeniu 1000 ml roztworu ponadtlenkowego.

Microdacyn® może być stosowany w podciśnieniowej terapii ran (NPWT).

Jak długo można używać produktu?

Microdacyn® zachowuje stabilność i jałowość do 60 dni po otwarciu.

Skuteczność produktu Microdacyn® – case study

Badania opublikowane w czasopiśmie „Journal of the American Colllege of Clinical Wound Specjalist” w 2016 r. pod tytułem „Wpływ roztworów Microdacyn® na owrzodzenia żylne kończyn dolnych” dowiodły, iż stosowanie tego roztworu zamiast standardowej soli fizjologicznej w połączeniu z wcześniejszym czyszczenie rany, oczyszczaniem autolitycznym, packingiem i opatrywaniem owrzodzeń żylnych kończyn dolnych skutkowało całkowitym zamknięciem wszystkich owrzodzeń.

W wynikach badania wskazano również, że roztwór Microdacyn® jest w stanie usunąć z rany biofilm. Jak wykazano, lekka abrazja za pomocą sterylnej gazy bawełnianej nasączonej roztworem oraz natychmiastowe przepłukanie rany większą ilością roztworu skutecznie niszczy istniejący biofilm in situ. Kilkukrotne powtórzenie tych czynności przez okres kilku dni pozwala zapobiec ponownemu pojawieniu się biofilmu. Wykazano, iż wodne roztwory Microdacyn® nawet w śladowych ilościach są w stanie zabić większość patogenów w łożysku rany w ciągu 30 sekund od ekspozycji, jak również zmniejszają degranulację mastocytów i aktywną dylatację kapilarną.

„Ten ostatni efekt ma duże znaczenie u chorych na VLU, ponieważ jednym z paradoksów w cukrzycy jest zmniejszenie perfuzji kapilarnej poprzez przetokę tętniczo-żylną na poziomie mikrokrążenia. Rozszerzenie kapilarne z kolei podnosi tepO2 w obrębie rany. Zauważyliśmy, że ta poprawa stężenia tlenu i perfuzja w tkance otaczającej ranę może trwać do 72 godzin po wystawieniu na działanie Microdacyn®” – zaznaczono w badaniu.

Microdacyn® jako środek stosowany w płukaniu otrzewnej i po sternotomii

Pozytywne wnioski dotyczące działania tego roztworu zostały potwierdzone w badaniach klinicznych. Porównano w nich skuteczność działania roztworu Microdacyn® z działaniem jodopowidonu pod kątem zmniejszenia ryzyka zakażenia rany po sternotomii u pacjentów poddawanych zabiegowi pomostowania aortalno-wieńcowego (bypass).

W badaniu wykazano, iż Microdacyn® jest bezpiecznym środkiem antybakteryjnym w irygacji ran po sternotomii i wykazuje skuteczniejsze działanie niż jodopowidon. Właściwości te potwierdzono również w przypadkach zakażenia stopy cukrzycowej.

Jak wykazały badania „Ocena przedoperacyjnego płukania otrzewnej za pomocą roztworu ponadtlenkowego w zapaleniu otrzewnej”, przedoperacyjne płukanie otrzewnej roztworem ponadtlenkowym u chorych z zapaleniem otrzewnej jest korzystne dla zmniejszania zachorowalności pooperacyjnej, niezależnie od przyczyny zapalenia otrzewnej.

Dzięki płukaniu dużą ilością ciepłego izotonicznego roztworu krystaloidalnego w przypadku rozlanego zapalenia otrzewnej usuwane są duże ilości cząstek stałych, krwi i skrzepów fibryny. Ponadto płyn ten rozcieńcza również resztkowe bakterie.

Jakie rodzaje produktu są dostępne?

W sprzedaży dostępny jest następujący asortyment produktów z linii Microdacyn®: 100 ml, 250 ml (atomizer), 500 ml, 990 ml (do terapii NPWT) oraz 5 l. Microdacyn® dostępny jest także w formie amorficznego żelu w butelkach o pojemnościach 120 g i 250 g.

Czy na produkt Microdacyn® przysługuje refundacja?

Microdacyn® w formie hydrożelu podlega refundacji w wysokości 30% we wskazaniu do owrzodzeń i EB (opakowania 120g oraz 250g). Po refundacji cena wynosi odpowiednio 16,12 zł  za opakowanie 120g oraz 24,21 zł za opakowanie 250g.

Microdacyn® roztwór nie podlega refundacji.

Gdzie kupić produkt Microdacyn®?

Microdacyn® dostępny jest w aptekach stacjonarnych i internetowych oraz na stronie kikgel.com.pl.

Wykaz literatury:

[1] Abdul Ramzisham Rahman Mohd, MS, Mohd Khairulasri Ghani i wsp., Irygacja Dermacynem®, a zmniejszanie ryzyka zakażenia rany po sternotomii, Forum Chirurgii Serca #2009-1162 13 (4), 2010 [Epub Sierpień 2010] doi: 10.1532/HSF98.20091162

[2] Wpływ roztworów Microdacyn na owrzodzenia żylne kończyn dolnych (VLU): Doświadczenie z 1249 VLU u 897 Pacjentów, Journal of the American College of Clinical Wound Specialists (2016) 6, 32–7

[3] Javier Aragón-Sánchez, MD, PhD1, Jose Luis Lázaro-Martínez, DPM, PhD2, Yurena Quintana-Marrero, RN1 i wsp., Super-Oxidized Solution (Dermacyn Wound Care) as Adjuvant Treatment in the Postoperative Management of Complicated Diabetic Foot Osteomyelitis: Preliminary Experience in a Specialized Department, The International Journal of Lower Extremity Wounds 12(2) 130–137 © The Author(s) 2013

[4] *Sheeraz M. Khan, A K Verma, Mohd. Shahid i wsp., Ocena przedoperacyjnego płukania otrzewnej za pomocą roztworu ponadtlenkowego w zapaleniu otrzewnej, MIDDLE EAST JOURNAL OF INTERNAL MEDICINE • TOM 2, WYDANIE 3

[5] Fermín R Martínez-De Jesús, Antonio Ramos-De la Medina, José María Remes-Troche i wsp., Skuteczność i bezpieczeństwo stosowania roztworu rodników ponadtlenkowych o neutralnym pH (DERMACYN® / MICRODACYN®) w ciężkich zakażeniach w przebiegu zespołu stopy cukrzycowej, ©2007 Blackwell Publishing Ltd and Medicalhelpines.com Inc. * International Wound Journal * doi: 10.1111/j.1742‐481X.2007.00363.x

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