N- Butil 2 Siyanoakrilatın Biyolojik Etkilerinin Araştırılması
Yıl 2020,
, 20 - 31, 21.04.2020
Oğuz Karahan
,
Mahmut Balkan
,
Erhan Hafız
Emced Khalil
Öz
Amaç: N- Butil 2 Siyanoakrilat kullanılan bir cerrahi yapıştırıcıdır. Bu çalışmada N-Butil 2 siyanoakrilatın biyouyumluluk analizleri deneysel olarak değerlendirilmiştir.
Gereç Yöntem: Wistar Albino cinsi, sağlıklı 16 erkek (250 ± 5 gram) yetişkin rat kontrol ve çalışma gruplarına bölündü. Kontrol grubundan normal histolojik yapının belirlenmesi ve rutin fizyolojik izlem amaçlandı. Çalışma gruplarında 0.3 ml N-Butil 2 siyanoakrilat enjeksiyonu, bel ve sırt traş edilen grupta irritasyon ve sensitizasyon değerlendirmesi için subkutan yoldan, sağ femur bölgesi traş edilen grubunda sitotoksisite değerlendirmesi için intramüsküler yoldan ve vasküler uygulama grubunda sistemik toksisite değerlendirmesi için kuyruk ven enjeksiyonu yoluyla uygulandı. Yetmiş iki saatlik gözlem süresinden sonra ratlar sakrifiye edilerek, venöz endotel, kas, dermal ve epidermal dokular histopatolojik olarak incelendi.
Bulgular: Sadece intravenöz uygulamada belirgin endotel harabiyeti izlendi. Sensitizasyon, irritasyon, sitotoksisite gibi testlerde aşırı reaksiyon ve belirgin histopatolojik değişiklik izlenmedi.
Sonuç: Cerrahi bir yapıştırıcı olarak sadece N-Butil 2 siyanoakrilatın intravasküler olarak uygulanması, lokal ve sistemik etkiler açısından ileri düzeyde doku hasarına yol açtı. Ancak, bu deneysel model klinik kapsamlı çalışmalarla desteklenmelidir.
Destekleyen Kurum
Bu çalışma Dicle Üniversitesi Sağlık Bilimleri Enstitüsü Tıbbi Biyoloji Anabilim Dalınca Oğuz KARAHAN 'a ait doktora tezi olarak hazırlanıp 10319698 numara ile sunulmuş 28.01.2020 tarihinde onaylanarak doktora tamamlandıktan sonra yayın aşamasına getirilmiştir.
Kaynakça
- 1. Ochsner JL. Minimally Invasive Surgical Procedures. Ochsner J. 2000; 2(3): 135–136.
- 2. Ronco V, Dard M. A novel suturing approach for tissue displacement within minimally invasive periodontal plastic surgery. Clin Case Rep. 2016; 4(8): 831–837.
- 3. Silverstein LH, Kurtzman GM. A review of dental suturing for optimal soft-tissue management. Compend Contin Educ Dent. 2005;26(3):163-6, 169-70
- 4. Singh PK, Degala S, Shetty S, Rai VS, Das A. To Evaluate the Efficacy and Effectiveness of N-butyl-2-cyanoacrylate glue (TRU SEAL) in Closure of Oral and Maxillofacial Laceration and Surgical Incisions. J Maxillofac Oral Surg. 2019;18(1):131-138. doi: 10.1007/s12663-018-1111-6.
- 5. Pujari-Palmer M, Guo H, Wenner D, et al., A Novel Class of Injectable Bioceramics that Glue Tissues and Biomaterials. Materials (Basel). 2018 Dec 7;11(12). pii: E2492. doi: 10.3390/ma11122492.
- 6. Balcıoğlu S., Alifatik Yapıdaki İzosiyanatlarla Şeker Temelli Yapıştırıcı Poliüretan Sentezi ve İn-Vitro Biyouyumluluk Özelliklerinin İncelenmesi. Yüksek Lisans Tezi. İnönü Üniversitesi Fen Bilimleri Enstitüsü. Malatya. 2015. http://openaccess.inonu.edu.tr:8080/xmlui/handle/11616/5911
- 7. Çelik D., Tavşanlarda Septal Kartilajın Anterior Nazal Spina’ya Tespiti İçin Kullanılan N-Butil-2 Siyanoakrilat (Histoacryl) Etkinliği ve Histopatolojik Değerlendirilmesi.Doktora Tezi. Şişli Etfal Eğitim Ve Araştırma Hastanesi II.Kulak Burun Boğaz ve Baş Boyun Cerrahisi Kliniği. İstanbul. 2006. http://www.istanbulsaglik.gov.tr/w/tez/pdf/kbb/dr_deniz_celik.pdf
- 8. Bhalla RK, Lesser THC. Simple, painless, cosmetic closure of endaural incisions. The J Laryngol Otol. 2003;117:67-68
- 9. Matras H. Fibrin seal: The state of the art. Joral Maxillofacial Surg.1985:43;605
- 10. Toriumi DM, Raslan WF, Friedman M, Tardy E. Histotoxicity of cyanoacrylate tissue adhezives. Arch Otolaryngol Head Neck Surg.May1990;116:546-550
- 11. ISO (2010) ISO/TC 194 10993-10 - Biological evaluation of medical devices -- Part 10: Tests for irritation and skin sensitization. International Organization for Standardization, Geneva, Switzerland.
- 12. ISO (2012) ISO/TC 194 10993-12 - Biological evaluation of medical devices -- Part 12: Sample preparation and reference materials. International Organization for Standardization, Geneva, Switzerland.
- 13. Galia CR, Macedo CA, Rosito R, Mello TM, Camargo LM, Moreira LF. In vitro and in vivo evaluation of lyophilized bovine bone biocompatibility. Clinics (Sao Paulo). 2008;63(6):801-6.
- 14. ISO (2009) ISO/TC 194 10993-10 - Biological evaluation of medical devices -- Part 11: Systemic toxicity tests. International Organization for Standardization, Geneva, Switzerland
- 15. Willert HG, Buchhorn GH, Fayyazi A, et al., Metal-on-metal bearings and hypersensitivity in patients with artificial hip joints. A clinical and histomorphological study. J Bone Joint Surg Am. 2005;87(1):28-36.
- 16. Tezcan O, Caliskan A, Demirtas S, et al., Effects of Hyperbaric Oxygen Treatment on Renal System. Iran J Kidney Dis. 2017;11(1):18-22.
- 17. ISO (2007) 10993-6: Biological Evaluation of Medical Devices: Test for local effects after implantation. International Organization for Standardization, Geneva, Switzerland.
- 18. Ellis DA, Shaikh A. The ideal tissue adhezive in facial plastic and reconstructive surgery. J Otolaryngol.1990;19:68-72
- 19. Eng J, Sabanathan S. Succesful closure of bronchopleural fistula with adhezive tissue.Scand J Thor Cardiovasc Surg 1990;34:157-159
- 20. Kartal N, Sav A, Küllü S. Izobutil Siyanoakrilata Karşı Oluşan Mast Hücre cevabının Hıstopatolojik Olarak Değerlendirilme Türk Patoloji Dergisi 1991;7(2):52-55
- 21. Sağlıyan A, Günay C, Han MC, Yaman İ. Tavşanlarda Karaciğer Cerrahisinde Fibrin Yapıştırıcı Kullanımı: Deneysel Çalışma, F.Ü.Sağ.Bil.Vet.Derg. 2010: 24 (2): 63 – 69
- 22. Reckers LJ, Fagundes DJ, Cohen M, Raymundo JL, Moreira MB, Paiva VC. Medial meniscus transplantation using cyanoacrylate in rabbits. Acta Cir Bras. 2006 ;21(2):92-6.
- 23. Ayan İ, Çolak M, Ballı E, Öztuna S, Kuyurtar F. Invivo application of hystoacryl (n–butyl–2–syanoacrylate) adhesive for meniscal tears: experimental study in rabbits. Joint Dis Rel Surg 2008; 19(3):112-118
- 24. Öztuna V, Yılmaz A, Yılmaz C, et al., The use of N-butyl-2-cyanoacrylate (Histoacryl) in primary tendon repair: a biomechanical study with sheep flexor tendons. Acta Orthop Traumatol Turc 2005;39(3):258-262
- 25. Reukov V, Maximov V, Vertegel A. Proteins conjugated to poly(butyl cyanoacrylate) nanoparticles as potential neuroprotective agents. Biotechnol Bioeng. 2011;108(2):243-52
- 26. Yıldırım G, Güngörmüş M, Gürbüz G, Kaya Ö, Nalbantoğlu NG. Oral Mukoza Kesilerinde Sütür Ve Butıl-2-Siyanoakrílatın Klinik Ve Hıstopatolojik Olarak Karşılaştırılması Atatürk Üniv.Diş Hck.Fak.Derg.1991; 9(2): 1-8.1991
- 27. Pérez M, Fernández I, Márquez D, Bretaña RM. Use of N-butyl-2-cyanoacrylate in oral surgery: biological and clinical evaluation. Artif Organs. 2000;24(3):241-3.
- 28. Singer AJ, Quinn JV, Hollander JE. The cyanoacrylate topical skin adhesives. American Journal of Emergency Medicine. 2008;26: 490-496.
- 29. Bhatia SK. Traumatic injuries. In: Bhatia SK, editor. Biomaterials for clinical applications. New York, 2010; 213-258 p.
- 30. Bouten PJM, Zonjee M, Bender J, et al., The chemistry of tissue adhesive materials. Progress in Polymer Science. 2014; 39: 1375-1405.
- 31. Schwensen JF, Friis UF, Zachariae C, Johansen JD. Sensitization to cyanoacrylates caused by prolonged exposure to a glucose sensor set in a diabetic child. Contact Dermatitis. 2016;74(2):124-5.
- 32. Ayyıldız SN, Ayyıldız A. Cyanoacrylic tissue glues: Biochemical properties and their usage in urology. Turk J Urol. 2017;43(1):14-24.
- 33. Kukleta JF, Freytag C, Weber M. Efficiency and safety of mesh fixation in laparoscopic inguinal hernia repair using n-butyl cyanoacrylate: long-term biocompatibility in over 1,300 mesh fixations. Hernia. 2012; 16(2):153-62.
- 34. Favard N, Moulin M, Fauque P, et al., Comparison of three different embolic materials for varicocele embolization: retrospective study of tolerance, radiation and recurrence rate. Quant Imaging Med Surg. 2015;5:806–14
- 35. Akgül T, Ayyildiz A, Cebeci O, et al., Effect of cyanoacrylic glue on penile fracture: an experimental study. J Urol. 2008; 180(2):749-52.
- 36. Loffroy R, Guiu B, Cercueil JP, Krausé D. Endovascular therapeutic embolisation: an overview of occluding agents and their effects on embolised tissues. Curr Vasc Pharmacol. 2009; 7(2):250-63
Investigation of Biological Effects of N- Butyl 2 Cyanoacrylate
Yıl 2020,
, 20 - 31, 21.04.2020
Oğuz Karahan
,
Mahmut Balkan
,
Erhan Hafız
Emced Khalil
Öz
Aim: N-Butyl 2 cyanoacrylate is a frequently utilizing agent as a surgical adhesive. Biocompatibility analyses of N-Butyl 2 cyanoacrylate were evaluated in this study.
Material and Method: Wistar Albino genus 16 healthy adult male (250 ± 5 gram) rats were divided into control and study groups. Determination of normal histological structure and routine physiologic observation was aimed in control group. In the study groups, 0.3 ml N-Butyl 2 cyanoacrylate injection were applied, via subcutaneous route for irritation and sensitization evaluation in the waist and back shaved group, via intramuscular route for cytotoxicity evaluation in the right femoral shaved group, and via tail vein injection for systemic toxicity evaluation in vascular administration group. Rats were sacrificed after 72. hours observation period and venous endothelium, muscular, dermal and epidermal tissues were examined histopathologically.
Findings: Marked endothelial injury were detected in only intravenous administration. Extreme reaction and marked histopatholgical changes were not observed in regards of irritation, sensitization and cytotoxicity groups .
Conclusion: Only intravascular administration of N-Butyl 2 cyanoacrylate, as a surgical adhesive usage, was lead advanced tissue injury in regards of local and systemic effects. However, this experimental model should be supported with clinical comprehensive studies.
Kaynakça
- 1. Ochsner JL. Minimally Invasive Surgical Procedures. Ochsner J. 2000; 2(3): 135–136.
- 2. Ronco V, Dard M. A novel suturing approach for tissue displacement within minimally invasive periodontal plastic surgery. Clin Case Rep. 2016; 4(8): 831–837.
- 3. Silverstein LH, Kurtzman GM. A review of dental suturing for optimal soft-tissue management. Compend Contin Educ Dent. 2005;26(3):163-6, 169-70
- 4. Singh PK, Degala S, Shetty S, Rai VS, Das A. To Evaluate the Efficacy and Effectiveness of N-butyl-2-cyanoacrylate glue (TRU SEAL) in Closure of Oral and Maxillofacial Laceration and Surgical Incisions. J Maxillofac Oral Surg. 2019;18(1):131-138. doi: 10.1007/s12663-018-1111-6.
- 5. Pujari-Palmer M, Guo H, Wenner D, et al., A Novel Class of Injectable Bioceramics that Glue Tissues and Biomaterials. Materials (Basel). 2018 Dec 7;11(12). pii: E2492. doi: 10.3390/ma11122492.
- 6. Balcıoğlu S., Alifatik Yapıdaki İzosiyanatlarla Şeker Temelli Yapıştırıcı Poliüretan Sentezi ve İn-Vitro Biyouyumluluk Özelliklerinin İncelenmesi. Yüksek Lisans Tezi. İnönü Üniversitesi Fen Bilimleri Enstitüsü. Malatya. 2015. http://openaccess.inonu.edu.tr:8080/xmlui/handle/11616/5911
- 7. Çelik D., Tavşanlarda Septal Kartilajın Anterior Nazal Spina’ya Tespiti İçin Kullanılan N-Butil-2 Siyanoakrilat (Histoacryl) Etkinliği ve Histopatolojik Değerlendirilmesi.Doktora Tezi. Şişli Etfal Eğitim Ve Araştırma Hastanesi II.Kulak Burun Boğaz ve Baş Boyun Cerrahisi Kliniği. İstanbul. 2006. http://www.istanbulsaglik.gov.tr/w/tez/pdf/kbb/dr_deniz_celik.pdf
- 8. Bhalla RK, Lesser THC. Simple, painless, cosmetic closure of endaural incisions. The J Laryngol Otol. 2003;117:67-68
- 9. Matras H. Fibrin seal: The state of the art. Joral Maxillofacial Surg.1985:43;605
- 10. Toriumi DM, Raslan WF, Friedman M, Tardy E. Histotoxicity of cyanoacrylate tissue adhezives. Arch Otolaryngol Head Neck Surg.May1990;116:546-550
- 11. ISO (2010) ISO/TC 194 10993-10 - Biological evaluation of medical devices -- Part 10: Tests for irritation and skin sensitization. International Organization for Standardization, Geneva, Switzerland.
- 12. ISO (2012) ISO/TC 194 10993-12 - Biological evaluation of medical devices -- Part 12: Sample preparation and reference materials. International Organization for Standardization, Geneva, Switzerland.
- 13. Galia CR, Macedo CA, Rosito R, Mello TM, Camargo LM, Moreira LF. In vitro and in vivo evaluation of lyophilized bovine bone biocompatibility. Clinics (Sao Paulo). 2008;63(6):801-6.
- 14. ISO (2009) ISO/TC 194 10993-10 - Biological evaluation of medical devices -- Part 11: Systemic toxicity tests. International Organization for Standardization, Geneva, Switzerland
- 15. Willert HG, Buchhorn GH, Fayyazi A, et al., Metal-on-metal bearings and hypersensitivity in patients with artificial hip joints. A clinical and histomorphological study. J Bone Joint Surg Am. 2005;87(1):28-36.
- 16. Tezcan O, Caliskan A, Demirtas S, et al., Effects of Hyperbaric Oxygen Treatment on Renal System. Iran J Kidney Dis. 2017;11(1):18-22.
- 17. ISO (2007) 10993-6: Biological Evaluation of Medical Devices: Test for local effects after implantation. International Organization for Standardization, Geneva, Switzerland.
- 18. Ellis DA, Shaikh A. The ideal tissue adhezive in facial plastic and reconstructive surgery. J Otolaryngol.1990;19:68-72
- 19. Eng J, Sabanathan S. Succesful closure of bronchopleural fistula with adhezive tissue.Scand J Thor Cardiovasc Surg 1990;34:157-159
- 20. Kartal N, Sav A, Küllü S. Izobutil Siyanoakrilata Karşı Oluşan Mast Hücre cevabının Hıstopatolojik Olarak Değerlendirilme Türk Patoloji Dergisi 1991;7(2):52-55
- 21. Sağlıyan A, Günay C, Han MC, Yaman İ. Tavşanlarda Karaciğer Cerrahisinde Fibrin Yapıştırıcı Kullanımı: Deneysel Çalışma, F.Ü.Sağ.Bil.Vet.Derg. 2010: 24 (2): 63 – 69
- 22. Reckers LJ, Fagundes DJ, Cohen M, Raymundo JL, Moreira MB, Paiva VC. Medial meniscus transplantation using cyanoacrylate in rabbits. Acta Cir Bras. 2006 ;21(2):92-6.
- 23. Ayan İ, Çolak M, Ballı E, Öztuna S, Kuyurtar F. Invivo application of hystoacryl (n–butyl–2–syanoacrylate) adhesive for meniscal tears: experimental study in rabbits. Joint Dis Rel Surg 2008; 19(3):112-118
- 24. Öztuna V, Yılmaz A, Yılmaz C, et al., The use of N-butyl-2-cyanoacrylate (Histoacryl) in primary tendon repair: a biomechanical study with sheep flexor tendons. Acta Orthop Traumatol Turc 2005;39(3):258-262
- 25. Reukov V, Maximov V, Vertegel A. Proteins conjugated to poly(butyl cyanoacrylate) nanoparticles as potential neuroprotective agents. Biotechnol Bioeng. 2011;108(2):243-52
- 26. Yıldırım G, Güngörmüş M, Gürbüz G, Kaya Ö, Nalbantoğlu NG. Oral Mukoza Kesilerinde Sütür Ve Butıl-2-Siyanoakrílatın Klinik Ve Hıstopatolojik Olarak Karşılaştırılması Atatürk Üniv.Diş Hck.Fak.Derg.1991; 9(2): 1-8.1991
- 27. Pérez M, Fernández I, Márquez D, Bretaña RM. Use of N-butyl-2-cyanoacrylate in oral surgery: biological and clinical evaluation. Artif Organs. 2000;24(3):241-3.
- 28. Singer AJ, Quinn JV, Hollander JE. The cyanoacrylate topical skin adhesives. American Journal of Emergency Medicine. 2008;26: 490-496.
- 29. Bhatia SK. Traumatic injuries. In: Bhatia SK, editor. Biomaterials for clinical applications. New York, 2010; 213-258 p.
- 30. Bouten PJM, Zonjee M, Bender J, et al., The chemistry of tissue adhesive materials. Progress in Polymer Science. 2014; 39: 1375-1405.
- 31. Schwensen JF, Friis UF, Zachariae C, Johansen JD. Sensitization to cyanoacrylates caused by prolonged exposure to a glucose sensor set in a diabetic child. Contact Dermatitis. 2016;74(2):124-5.
- 32. Ayyıldız SN, Ayyıldız A. Cyanoacrylic tissue glues: Biochemical properties and their usage in urology. Turk J Urol. 2017;43(1):14-24.
- 33. Kukleta JF, Freytag C, Weber M. Efficiency and safety of mesh fixation in laparoscopic inguinal hernia repair using n-butyl cyanoacrylate: long-term biocompatibility in over 1,300 mesh fixations. Hernia. 2012; 16(2):153-62.
- 34. Favard N, Moulin M, Fauque P, et al., Comparison of three different embolic materials for varicocele embolization: retrospective study of tolerance, radiation and recurrence rate. Quant Imaging Med Surg. 2015;5:806–14
- 35. Akgül T, Ayyildiz A, Cebeci O, et al., Effect of cyanoacrylic glue on penile fracture: an experimental study. J Urol. 2008; 180(2):749-52.
- 36. Loffroy R, Guiu B, Cercueil JP, Krausé D. Endovascular therapeutic embolisation: an overview of occluding agents and their effects on embolised tissues. Curr Vasc Pharmacol. 2009; 7(2):250-63