A post-market, prospective, multi-center, single-arm clinical investigation of Phasix™ mesh for VHWG grade 3 midline incisional hernia repair: a research protocol

M M J van Rooijen, A P Jairam, T Tollens, L N Jørgensen, T S de Vries Reilingh, G Piessen, F Köckerling, M Miserez, A C J Windsor, F Berrevoet, R H Fortelny, B Dousset, G Woeste, H L van Westreenen, F Gossetti, J F Lange, G W M Tetteroo, A Koch, L F Kroese, J Jeekel, M M J van Rooijen, A P Jairam, T Tollens, L N Jørgensen, T S de Vries Reilingh, G Piessen, F Köckerling, M Miserez, A C J Windsor, F Berrevoet, R H Fortelny, B Dousset, G Woeste, H L van Westreenen, F Gossetti, J F Lange, G W M Tetteroo, A Koch, L F Kroese, J Jeekel

Abstract

Background: Incisional heia is a frequent complication of midline laparotomy. The use of mesh in hernia repair has been reported to lead to fewer recurrences compared to primary repair. However, in Ventral Hernia Working Group (VHWG) Grade 3 hernia patients, whose hernia is potentially contaminated, synthetic mesh is prone to infection. There is a strong preference for resorbable biological mesh in contaminated fields, since it is more able to resist infection, and because it is fully resorbed, the chance of a foreign body reaction is reduced. However, when not crosslinked, biological resorbable mesh products tend to degrade too quickly to facilitate native cellular ingrowth. Phasix™ Mesh is a biosynthetic mesh with both the biocompatibility and resorbability of a biological mesh and the mechanical strength of a synthetic mesh. This multi-center single-arm study aims to collect data on safety and performance of Phasix™ Mesh in Grade 3 hernia patients.

Methods: A total of 85 VHWG Grade 3 hernia patients will be treated with Phasix™ Mesh in 15 sites across Europe. The primary outcome is Surgical Site Occurrence (SSO) including hematoma, seroma, infection, dehiscence and fistula formation (requiring intervention) through 3 months. Secondary outcomes include recurrence, infection and quality of life related outcomes after 24 months. Follow-up visits will be at drain removal (if drains were not placed, then on discharge or staple removal instead) and in the 1st, 3rd, 6th, 12th, 18th and 24th month after surgery.

Conclusion: Based on evidence from this clinical study Depending on the results this clinical study will yield, Phasix™ Mesh may become a preferred treatment option in VHWG Grade 3 patients.

Trial registration: The trial was registered on March 25, 2016 on clinicaltrials.gov: NCT02720042 .

Keywords: Biosynthetic mesh; Complex hernia; Complications; Incisional hernia; Mesh repair; Midline laparotomy; Surgical site occurrence.

Conflict of interest statement

Ethics approval and consent to participate

This study will be conducted in accordance with the principles of the Declaration of Helsinki and Good Clinical Practice guidelines. The Medical Ethical Committee of the Erasmus Medical Center and the Institutional Review Board of every participating hospital have approved the protocol. Written informed consent will be obtained from all subjects. A model consent form will be available upon reasonable request. All study data will be recorded in electronic Case Report Forms provided to the investigational site. Site and subject numbers will be used to track subject information throughout the study.

Consent for publication

Not applicable.

Competing interests

The study was funded and reviewed by C. R. Bard. (the sponsor).

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Hernia grading system: assessment of risk for surgical site occurrences [13]. (Reprinted from Surgery, 148(3), The Ventral Hernia Working Group, Incisional ventral hernias: Review of the literature and recommendations regarding the grading and technique of repair, 544-558, Copyright (2010), with permission from Elsevier)

References

    1. Luijendijk RW, Hop WC, van den Tol MP, de Lange DC, Braaksma MM, JN IJ, Boelhouwer RU, de Vries BC, Salu MK, Wereldsma JC, et al. A comparison of suture repair with mesh repair for incisional hernia. N Engl J Med. 2000;343(6):392–398. doi: 10.1056/NEJM200008103430603.
    1. Hoer J, Lawong G, Klinge U, Schumpelick V. Factors influencing the development of incisional hernia. A retrospective study of 2,983 laparotomy patients over a period of 10 years. Chirurg. 2002;73(5):474–480. doi: 10.1007/s00104-002-0425-5.
    1. Burger JW, Luijendijk RW, Hop WC, Halm JA, Verdaasdonk EG, Jeekel J. Long-term follow-up of a randomized controlled trial of suture versus mesh repair of incisional hernia. Ann Surg. 2004;240(4):578–583.
    1. van Ramshorst GH, Eker HH, Hop WC, Jeekel J, Lange JF. Impact of incisional hernia on health-related quality of life and body image: a prospective cohort study. Am J Surg. 2012;204(2):144–150. doi: 10.1016/j.amjsurg.2012.01.012.
    1. Sauerland S, Walgenbach M, Habermalz B, Seiler CM, Miserez M: Laparoscopic versus open surgical techniques for ventral or incisional hernia repair. In: Cochrane Database of Systematic Reviews. John Wiley & Sons, Ltd; 2011.
    1. van Geffen HJ, Simmermacher RK, van Vroonhoven TJ, van der Werken C. Surgical treatment of large contaminated abdominal wall defects. J Am Coll Surg. 2005;201(2):206–212. doi: 10.1016/j.jamcollsurg.2005.03.030.
    1. Ramirez OM, Ruas E, Dellon AL. "components separation" method for closure of abdominal-wall defects: an anatomic and clinical study. Plast Reconstr Surg. 1990;86(3):519–526. doi: 10.1097/00006534-199009000-00023.
    1. DiBello Joseph N., Moore John H. Sliding Myofascial Flap of the Rectus Abdominus Muscles for the Closure of Recurrent Ventral Hernias. Plastic & Reconstructive Surgery. 1996;98(3):464–469. doi: 10.1097/00006534-199609000-00016.
    1. Mathes T, Walgenbach M, Siegel R. Suture versus mesh repair in primary and incisional ventral hernias: a systematic review and meta-analysis. World J Surg. 2016;40(4):826–835. doi: 10.1007/s00268-015-3311-2.
    1. Cobb WS, Kercher KW, Heniford BT. Laparoscopic repair of incisional hernias. Surg Clin North Am. 2005;85(1):91–103. doi: 10.1016/j.suc.2004.09.006.
    1. Markar SR, Karthikesalingam A, Alam F, Tang TY, Walsh SR, Sadat U. Partially or completely absorbable versus nonabsorbable mesh repair for inguinal hernia: a systematic review and meta-analysis. Surg Laparosc Endosc Percutan Tech. 2010;20(4):213–219. doi: 10.1097/SLE.0b013e3181ed86a2.
    1. Slater NJ, van Goor H, Bleichrodt RP. Large and complex ventral hernia repair using "components separation technique" without mesh results in a high recurrence rate. Am J Surg. 2015;209(1):170–179. doi: 10.1016/j.amjsurg.2014.02.013.
    1. Ventral Hernia Working Group. Breuing K, Butler CE, Ferzoco S, Franz M, Hultman CS, Kilbridge JF, Rosen M, Silverman RP, Vargo D. Incisional ventral hernias: review of the literature and recommendations regarding the grading and technique of repair. Surgery. 2010;148(3):544–558. doi: 10.1016/j.surg.2010.01.008.
    1. Zheng F, Lin Y, Verbeken E, Claerhout F, Fastrez M, De Ridder D, Deprest J. Host response after reconstruction of abdominal wall defects with porcine dermal collagen in a rat model. Am J Obstet Gynecol. 2004;191(6):1961–1970. doi: 10.1016/j.ajog.2004.01.091.
    1. Kissane NA, Itani KM. A decade of ventral incisional hernia repairs with biologic acellular dermal matrix: what have we learned? Plast Reconstr Surg. 2012;130(5 Suppl 2):194S–202S. doi: 10.1097/PRS.0b013e318265a5ec.
    1. Itani KM, Rosen M, Vargo D, Awad SS, Denoto G, 3rd, Butler CE, Group RS Prospective study of single-stage repair of contaminated hernias using a biologic porcine tissue matrix: the RICH study. Surgery. 2012;152(3):498–505. doi: 10.1016/j.surg.2012.04.008.
    1. Liang HC, Chang Y, Hsu CK, Lee MH, Sung HW. Effects of crosslinking degree of an acellular biological tissue on its tissue regeneration pattern. Biomaterials. 2004;25(17):3541–3552. doi: 10.1016/j.biomaterials.2003.09.109.
    1. Melman L, Jenkins ED, Hamilton NA, Bender LC, Brodt MD, Deeken CR, Greco SC, Frisella MM, Matthews BD. Early biocompatibility of crosslinked and non-crosslinked biologic meshes in a porcine model of ventral hernia repair. Hernia. 2011;15(2):157–164. doi: 10.1007/s10029-010-0770-0.
    1. Deeken CR, Melman L, Jenkins ED, Greco SC, Frisella MM, Matthews BD. Histologic and biomechanical evaluation of crosslinked and non-crosslinked biologic meshes in a porcine model of ventral incisional hernia repair. J Am Coll Surg. 2011;212(5):880–888. doi: 10.1016/j.jamcollsurg.2011.01.006.
    1. Wu Q, Wang Y, Chen G-Q. Medical application of microbial biopolyesters Polyhydroxyalkanoates. Artif Cells Blood Substit Immobil Biotechnol. 2009;37(1):1–12. doi: 10.1080/10731190802664429.
    1. Martin DP, Williams SF. Medical applications of poly-4-hydroxybutyrate: a strong flexible absorbable biomaterial. Biochem Eng J. 2003;16(2):97–105. doi: 10.1016/S1369-703X(03)00040-8.
    1. Chen G-Q, Wu Q. The application of polyhydroxyalkanoates as tissue engineering materials. Biomaterials. 2005;26(33):6565–6578. doi: 10.1016/j.biomaterials.2005.04.036.
    1. Martin DP, Badhwar A, Shah DV, Rizk S, Eldridge SN, Gagne DH, Ganatra A, Darois RE, Williams SF, Tai HC, et al. Characterization of poly-4-hydroxybutyrate mesh for hernia repair applications. J Surg Res. 2013;184(2):766–773. doi: 10.1016/j.jss.2013.03.044.
    1. Deeken CR, Matthews BD. Characterization of the mechanical strength, resorption properties, and histologic characteristics of a fully absorbable material (Poly-4-hydroxybutyrate-PHASIX mesh) in a porcine model of hernia repair. ISRN Surg. 2013;2013:238067. doi: 10.1155/2013/238067.
    1. NCT01961687 A Prospective, Multi-Center Study of Phasix™ Mesh for Ventral or Incisional Hernia Repair. .
    1. Guideline for the Prevention of Surgical Site Infection. .
    1. Roth JS, Anthone GJ, Selzer DJ, Poulose BK, Bittner JG, Hope WW, Dunn RM, Martindale RG, Goldblatt MI, Earle DB, et al. Prospective evaluation of poly-4-hydroxybutyrate mesh in CDC class I/high-risk ventral and incisional hernia repair: 18-month follow-up. Surg Endosc. 2018;32(4):1929–1936. doi: 10.1007/s00464-017-5886-1.
    1. Plymale MA, Davenport DL, Dugan A, Zachem A, Roth JS. Ventral hernia repair with poly-4-hydroxybutyrate mesh. Surg Endosc. 2018;32(4):1689–1694. doi: 10.1007/s00464-017-5848-7.
    1. Buell JF, Sigmon D, Ducoin C, Shapiro M, Teja N, Wynter E, Hanisee MK, Parker G, Kandil E, Darden M. Initial experience with biologic polymer scaffold (Poly-4-hydroxybuturate) in complex Abdominal Wall reconstruction. Ann Surg. 2017;266(1):185–188. doi: 10.1097/SLA.0000000000001916.
    1. Heniford BT, Walters AL, Lincourt AE, Novitsky YW, Hope WW, Kercher KW. Comparison of generic versus specific quality-of-life scales for mesh hernia repairs. J Am Coll Surg. 2008;206(4):638–644. doi: 10.1016/j.jamcollsurg.2007.11.025.
    1. EuroQol Group EuroQol--a new facility for the measurement of health-related quality of life. Health Policy. 1990;16(3):199–208. doi: 10.1016/0168-8510(90)90421-9.
    1. Won EJ, Lehman EB, Geletzke AK, Tangel MR, Matsushima K, Brunke-Reese D, Pichardo-Lowden AR, Pauli EM, Soybel DI. Association of postoperative hyperglycemia with outcomes among patients with complex ventral hernia repair. JAMA Surg. 2015;150(5):433–440. doi: 10.1001/jamasurg.2014.3160.
    1. Rodriguez-Unda N, Soares KC, Azoury SC, Baltodano PA, Hicks CW, Burce KK, Cornell P, Cooney CM, Eckhauser FE. Negative-pressure wound therapy in the Management of High-Grade Ventral Hernia Repairs. J Gastrointest Surg. 2015;19(11):2054–2061. doi: 10.1007/s11605-015-2894-0.
    1. Kugler Nathan W., Bobbs Melanie, Webb Travis, Carver Thomas W., Milia David, Paul Jasmeet S. A dual-stage approach to contaminated, high-risk ventral hernia repairs. Journal of Surgical Research. 2016;204(1):200–204. doi: 10.1016/j.jss.2016.04.065.
    1. Kanters AE, Krpata DM, Blatnik JA, Novitsky YM, Rosen MJ. Modified hernia grading scale to stratify surgical site occurrence after open ventral hernia repairs. J Am Coll Surg. 2012;215(6):787–793. doi: 10.1016/j.jamcollsurg.2012.08.012.
    1. Bondre IL, Holihan JL, Askenasy EP, Greenberg JA, Keith JN, Martindale RG, Roth JS, Liang MK, Ventral Hernia Outcomes C. Suture, synthetic, or biologic in contaminated ventral hernia repair. J Surg Res. 2016;200(2):488–494. doi: 10.1016/j.jss.2015.09.007.
    1. Fischer JP, Basta MN, Mirzabeigi MN, Kovach SJ., 3rd A comparison of outcomes and cost in VHWG grade II hernias between rives-Stoppa synthetic mesh hernia repair versus underlay biologic mesh repair. Hernia. 2014;18(6):781–789. doi: 10.1007/s10029-014-1309-6.
    1. Jones JW, Jurkovich GJ. Polypropylene mesh closure of infected abdominal wounds. Am Surg. 1989;55(1):73–76.
    1. Use of synthetic mesh in the infected field. .
    1. Kim H, Bruen K, Vargo D. Acellular dermal matrix in the management of high-risk abdominal wall defects. Am J Surg. 2006;192(6):705–709. doi: 10.1016/j.amjsurg.2006.09.003.
    1. Slater NJ, van der Kolk M, Hendriks T, van Goor H, Bleichrodt RP. Biologic grafts for ventral hernia repair: a systematic review. Am J Surg. 2013;205(2):220–230. doi: 10.1016/j.amjsurg.2012.05.028.

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