Buckypaper (BP) as absorbable adhesive for surgical application in abdominal wall issues

Campanelli, Giampiero. Hernia Volume: 19 Issue S1 (2015) ISSN: 1265-4906 Online ISSN: 1248-9204 Buckypaper (BP) as absorbable adhesive for surgical application in abdominal wall issues Chiaretti M(1), Martinelli A(2), Carru GA(3), Alunni Fegatelli D(4), Chiaretti AM(5), Consentino P(6), Chiaretti AI(1), Procacciante F(1) (1) Department of General Surgery “Paride Stefanini”, Sapienza University, Viale del Policlinico 155, Rome, 00161 (Italy) (2) Department of Chemistry, Sapienza University, P.le Aldo Moro 5, Rome, 00185 (Italy) (3) Policlinico Umberto I Hospital, Sapienza University, Viale del Policlinico 155, 00161 - Rome (Italy) (4) Public Health and Infective Illness, Sapienza University, P.le Aldo Moro 5, Rome, 00185 (Italy) (5) Istitute of Genetic Risearch G. Salvatore, Scienze e Tecnologie Genetiche Biogem; (6) Appialab Srl V. Latina, 286 00179 Rome (+39) 067825111www.appialab.it E-mail: massimo.chiaretti@uniroma1.it Introduction: One of the key issues relating to abdominal prosthetic surgery is the fixation of the abdominal mesh. Mesh displacement, improper or blind application of metal tacks and staples in laparoscopic surgery are the main causes of complications such as seroma[1], postoperative pain[2] and recurrence of hernia[3]. The well-established use of fibrin glue[4], or self-gripping commercial meshes, or suture meshes to fix prosthesis to damaged tissue may represent a risk associated to the transmission of unknown diseases related to the use of blood-derived materials[4] or pain caused by nerve entrapment or displacement. Moreover, it has been observed[1,5] that the use of fibrin glue for mesh fixation may be associated with incidence of postoperative seroma. An effective alternative to the conventional prosthesis fixation methods may be represented by devices able to adhere strongly and quickly[1,5] on wet[6] biological tissue. In view of a possible application of BP as adhesive absorbable tape in surgery, preliminary in vivo experiments were carried out on large-size pigs. Methods: We investigated the potential applicability of BP, a self-standing felt composed of multi-walled carbon nanotubes, as an adhesive tape on biological tissue compared with traditional methods of fixation of prosthetic meshes. Based on biological materials from experimentation on rabbits (in progress[7]) we carried out a comparative study on two sets of meshes: one of the sets was fixed with BP and the other set was fixed with traditional methods. We did this by carrying out bench surgery and performing mechanical peeling and shear adhesiveness tests on each set[5,8,9,10]. The in vivo experimentation was carried out on 30 Landrace female pigs weighing about 15 kg initially and 60 kg when they were sacrificed. The subjects were divided into two sets i.e., 15 for laparoscopic procedure and 15 for laparotomic procedure. Each group was further subdivided into an experimental set of 11 subjects for mesh fixation with BP and a control set of 4 subjects for traditional mesh fixation. Results: Experimental and control subsets did not show mortality or morbidity. Even after 90 days from the operation no significant neurovegetative or behavioral differences were observed. The BP fixing method shows stronger adhesiveness on wet tissues[6] than the mentioned traditional fixing methods. Checks on body weight monitoring curves show no significant differences between BP and control groups. Necroscopical and histological investigations show that BP elicits minimal adverse tissue response. Nanometric carbon nanotube aggregates were phagocytized by macrophages. Further, BP fragments were also observed in Bowman's urinary space. Finally, around the BP, a capsule of loose fibrous tissue is formed by collagen fibers deposited by fibroblasts which indicate a moderate cicatrisation reaction. Conclusion: Findings from our experiment are compatible with a stronger adhesiveness on wet biological tissue for the BP fixing method compared to traditional methods. Further studies are required to fully assess the nature of the BP debris, their toxicity potential and their metabolization. References 1. B. P. Jacob, N. J. Hogle, E. Durak, T. Kim, D. L. Fowler, Surg. Endosc. 2007, 21, 629 2. J. R. Eriksen, J. I. Bech, D. Linnemann, J. Rosemberg, Hernia 2008, 12, 483 3. W. B. Gaertner, M. E. Bonsack, J. P. Delaney, Hernia 2010, 14, 375 4. S. Olmi, A. Addis, C. Domeneghini, A. Scaini, E. Croce, Hernia. 2007, 11, 211 5. S. Bellucci, M. Chiaretti, P. Onorato, F. Rossella, M. S. Grandi, P. Galinetto, I. Sacco, F. Micciulla, Nanomedicine 2010, 5, 209 6. A. Martinelli, GA. Carru, L. D'Ilario, F. Caprioli, M. Chiaretti, F. Crisante, I. Francolini, and A. Piozzi. ACS Appl. Mater. Interfaces, DOI:10.1021/am400543s Publication Date (Web): 18 Apr 2013, http://pubs.acs.org on April 19, 2013 7. M. Chiaretti, G. A. Carru, Danilo Alunni Fegatelli, A. M. Chiaretti, A. Martinelli, (in progress) 8. M. Chiaretti, G. Mazzanti, S. Bosco, S. Bellucci, A. Cucina, F. Le Foche, G. A. Carru, S. Mastrangelo, A. Di Sotto, R. Masciangelo, A. M. Chiaretti, C. Balasubramanian, G. De Bellis, F. Micciulla, N. Porta, G. Deriu, A. Tiberia, J. Phys.: Condens. Matter 2008,20, 474203 9. A. Di Sotto, M. Chiaretti, G. A. Carru, S. Bellucci, G. Mazzanti, Toxicol. Lett. 2009, 184, 192 10. S. Bellucci, M. Chiaretti, A. Cucina, G.A. Carru,A.I. Chiaretti, Nanomedicine 2009, 4, 531

By: Sun, P.; Hu, S. B.; Cheng, X.; Li, M.; Guo, B.; Song, Z. F.; Zhang, Y.; Zheng, Q. C.; Hoyuela, C.; Vega, L.; Carvajal, F.; Blay, L.; Juvany, M.; Camps, J.; Veres, A.; Besora, P.; Trias, M.; Feliu, X.; Bellanova, G.; Viel, G.; et al. In: Hernia. April 2015 19(1):S157-S165; Springer Paris Language: English, Database: Springer Nature Journals PROTPCOLLO DI RICERCA PUBBLICATO SU: ClinicalTrials.gov Identifier: NCT02137018 https://register.clinicaltrials.gov FINANZIAMENTO RICERCA DI ATENEO INTERDIPARTIMENTALE prot. C26A10HCNR, founding of 35000€ DIPARTIMENTO DI CHIMICA: Prof Lucio D'Ilario, Prof. Andrea Martinelli, DIPARTIMENTO DI CHIRURGIA "PARIDE STEFANINI": Dott. Massimo Chiaretti , prot letter 0003306 project n° 304P25, interfaculty Chemistry Dep, General Surgery Paride Stefanini Dep. http://www.uniroma1.it Location National Health Institute (ISS Istituto Superiore di Sanità), Viale Regina Elena 299 Rome, Roma, Italy, 00161 "BP as a New Device for Surgery and Solid Cancer and Hematopoietic System Tumors Treatment. Effects of BP Implantation" (DM159) ClinicalTrials.gov Protocol and Results Registration System (PRS) Receipt Release Date: 12/30/2014 The objective of this project is to obtain results that can direct the search for the ultimate realization of a prosthetic device for use in abdominal surgery. Will be conducted systematic experiments in 30 New Zealand female rabbits (R1-R30), weighting about 3000 g (Harlan Laboratories).