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Safety and efficacy of prophylactic resorbable biosynthetic mesh following midline laparotomy in clean/contemned field: preliminary results of a randomized double blind prospective trial



Incisional hernia (IH) is one of the most common sequelae of laparotomy.

Materials and methods

We present a double-blind randomized study examining feasibility, safety and incisional hernia rate using a prophylactic Bio-A biosynthetic stripe (Gore) in a sub-lay position after midline laparotomy in patients undergoing operations in clean-contaminated and contaminated field. One hundred patients who underwent a midline laparotomy of at least 10 cm in a clean-contaminated and contaminated field were considered. Patients were divided into two groups: [Group A closed in double layer using PDS 0 with WL/SL of 1:4; Group B closure in double layer using PDS 0 and sub-lay positioning a 3 cm-wide BIO A (Gore) strip extended for the entire length of the incision]. The primary objective of the study was to identify IH rate in the two groups at 1- and 2-year follow-up. Secondary objective was to identify any differences in the two groups in terms of post-operative pain, morbidity and mortality.


Out of a total of 100 patients included in the study, a 2-year follow-up was possible for 47 patients in group A and 45 in group B. The incidence of IH was 11/47 in group A (22%) and 3/45 in group B (6%) [p < 0.01]. Furthermore, no statistically significant difference was noted about post-operative morbidity and pain related to the wall closure method.


The prophylactic use of a BIO-A biosynthetic stripe (Gore) showed a statistically significant reduction in the incisional hernia rate in patients who underwent clean-contaminated and contaminated surgery.

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  1. 1.

    Adotey JM (2006) Incisional hernia a review. Niger J Med 15:34–43

  2. 2.

    Carlson MA, Ludwig KA, Condon RE (1995) Ventral hernia and other complications of 1,000 midline incisions. S Med J 88:450–453

  3. 3.

    Van't Riet M, Steyerberg EW, Nellensteyn J, Bonjer HJ, Jeekel J, Friedman DW (2002) Meta-analysis of techniques for closure of midline abdominal incisions. Br J Surg 89(11):1350–1356

  4. 4.

    Payne R, Aldwinckle J, Ward SM et al (2016) Analysis of randomised trials comparing the use of prophylactic mesh to standard midline closure in the reduction of incisional hernia. Hernia 17:1653–1654

  5. 5.

    Diener MK, Voss S, Jensen K et al (2010) Elective midline laparotomy closure: the inline systematic review and meta-analysis. Ann Surg 251:843–856

  6. 6.

    Mudge M, Hughes LE (1985) Incisional hernia: a 10 year prospective study of incidence and attitudes. Br J Surg 72:70–71

  7. 7.

    Wadstrom J, Gerdin B (1990) Closure of the abdominal wall; how and why? clinical review. Acta Chir Scand 156:75–82

  8. 8.

    Gillion JF, Sanders D, Miserez M et al (2016) The economic burden of incisional ventral hernia repair: a multicentric cost analysis. Hernia 20:819–830

  9. 9.

    Diener MK, Voss S, Jensen K et al (2010) Elective midline laparotomy closure: the INLINE systematic review and metaanalysis. Ann Surg 251:843–856

  10. 10.

    Muysoms FE, Antoniou SA, Bury K et al (2015) European Hernia Society guidelines on the closure of abdominal wall incisions. Hernia 19:1–24

  11. 11.

    Veljkovic R, Protic M, Gluhovic A et al (2010) Prospective clinical trial of factors predicting the early development of incisional hernia after midline laparotomy. J Am Coll Surg 210:210–219

  12. 12.

    Nachiappan S, Markar S, Karthikesalingam A et al (2013) Prophylactic mesh placement in high-risk patients undergoing electivelaparotomy: a systematic review. World J Surg 37:1861–1871

  13. 13.

    Muysoms FE, Detry O, Vierendeels T et al (2016) Prevention of incisional hernias by prophylactic mesh-augmented reinforcement of midline laparotomies for abdominal aortic aneurysm treatment: a randomized controlled trial. Ann Surg 263:638–645

  14. 14.

    Park AE, Roth JS, Kavic SM (2006) Abdominal wall hernia. Curr Probl Surg. 43:326–375

  15. 15.

    Ventral Hernia Working Group, Breuing K, Butler CE, Ferzoco S et al (2010) Incisional ventral hernias: review of the literature and recommendations regarding the grading and technique of repair. Surgery 148:544

  16. 16.

    Carbonell AM, Criss CN, Cobb WS, Novitsky YW, Rosen MJ (2013) Outcomes of synthetic mesh in contaminated ventral hernia repairs. J Am Coll Surg 217(6):991–998

  17. 17.

    Rosen MJ, Bauer J, Harmaty M et al (2015) Multicenter, prospective, longitudinal study of the recurrence, surgical site infection, and quality of life after contaminated ventral hernia repair using biosynthetic absorbable mesh: the COBRA study. Ann Surg 265:205

  18. 18.

    Rosen M, DeNotoK G (2013) Butler DEvaluation of surgical outcomes of retro-rectus versus intraperitoneal reinforcement with bio-prosthetic mesh in the repair of contaminated ventral hernias. Hernia 17(31–3):5

  19. 19.

    Renard Y, de Mestier L, Henriques J et al (2019) Absorbable polyglactin vs. non-cross-linked porcine biological mesh for the surgical treatment of infected incisional hernia. J Gastrointest Surg.

  20. 20.

    Bondre IL, Holihan JL, Askenasy EP, Greenberg JA, Keith JN, Martindale RG et al (2016) Suture, synthetic, or biologic in contaminated ventral hernia repair. J Surg Res 200:488–494

  21. 21.

    Todd B, New CDC (2017) Guideline for the Prevention of Surgical Site Infection. Am J Nurs 117(8):17

  22. 22.

    Clavien PA, Barkun J, de Oliveira ML, Vauthey JN, Dindo D, Schulick RD, de Santibañes E, Pekolj J, Slankamenac K, Bassi C, Graf R, Vonlanthen R, Padbury R, Cameron JL, Makuuchi M (2009) Ann Surg 250(2):187–196

  23. 23.

    Mangram AJ, Horan TC, Pearson ML et al (1999) Guideline for prevention of surgical site infection, Hospital Infection Control Practices Advisory Committee. Infect Control Hosp Epidemiol 20:250–278

  24. 24.

    Brosi P, Glauser P, Speich B et al (2017) Prophylactic intraperitoneal onlay mesh reinforcement reduces the risk of incisional hernia, two-year results of a randomized clinical trial. World J Surg 42:1687–1694

  25. 25.

    Bloemen A, van Dooren P, Huizinga BF et al (2012) Comparison of ultrasonography and physical examination in the diagnosis of incisional hernia in a prospective study. Hernia 16:53–57

  26. 26.

    Leber GE, Garb JL, Alexander AI et al (1998) Long-term complications associated with prosthetic repair of incisional hernias. Arch Surg 133:378–382

  27. 27.

    Berrevoet F, Vanlander A, Sainz-Barriga M et al (2013) Infected large pore meshes may be salvaged by topical negative pressure therapy. Hernia 17:67–73

  28. 28.

    Bevis PM, Windhaber RA, Lear PA et al (2010) Randomized clinical trial of mesh versus sutured wound closure after open abdominal aortic aneurysm surgery. Br J Surg 97:1497–1502

  29. 29.

    Bhangu A, Fitzgerald JE, Singh P et al (2013) Systematic review and meta-analysis of prophylactic mesh placement for prevention of incisional hernia following midline laparotomy. Hernia 17:445–455

  30. 30.

    Friedman DW, Boyd CD, Norton P, Greco RS, Boyarsky AH, Mackenzie JW et al (1993) Increases in type III collagen gene expression and protein synthesis in patients with inguinal hernias. Ann Surg 218(6):754–760

  31. 31.

    Fortelny RH (2018) Abdominal wall closure in elective midline laparotomy: the current recommendations. Front Surg 5:34

  32. 32.

    Muysoms FE, Antoniou SA, Bury K, Campanelli G, Conze J, Cuccurullo D et al (2015) European Hernia Society guidelines on the closure of abdominal wall incisions. Hernia 19(1):1–24

  33. 33.

    Jairam AP, Timmermans L, Eker HH, Pierik R, van Klaveren D, Steyerberg EW et al (2017) Prevention of incisional hernia with prophylactic onlay and sublay mesh reinforcement versus primary suture only in midline laparotomies (PRIMA): 2-year follow-up of a multicentre, double-blind, randomised controlled trial. Lancet 390(10094):567–576

  34. 34.

    Wang X-C, Zhang D, Yang Z-X et al (2017) Mesh reinforcement for the prevention of incisional hernia formation: a systematic review and meta-analysis of randomized controlled trials. J Surg Res 209:17–29

  35. 35.

    Timmermans L, de Goede B, Eker HH et al (2013) Meta-analysis of primary mesh augmentation as prophylactic measure to prevent incisional hernia. Dig Surg 30:401–409

  36. 36.

    Cruse P, Foord R (1980) The epidemiology of wound infection. A ten-year prospective study of 62,939 wounds. Surg Clin N Am 60:27–40

  37. 37.

    Olson M, O’Connor M, Schwartz M (1984) A 5-year prospective study of 20,193 wounds at the Minneapolis VA Medical Center. Ann Surg 199:253–259

  38. 38.

    Birindelli A, Sartelli M, Di Saverio S et al (2017) update of the WSES guidelines for emergency repair of complicated abdominal wall hernias. World J Emerg Surg 12:37

  39. 39.

    Cross AJ, Buchwald PL, Frizelle FA, Eglinton TW (2017) Meta-analysis of prophylactic mesh to prevent parastomal hernia. Br J Surg 104(3):179–186

  40. 40.

    Fischer JP, Basta MN, Krishnan NM, Wink JD, Kovach SJ (2016) A cost-utility assessment of mesh selection in clean-contaminated ventral hernia repair. Plast Reconstr Surg 137(2):647–659

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Correspondence to F. Pizza.

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Conflict of interest

The authors declare that they have no conflict of interest.

Ethical approval

This study was approved by the research ethics board of the ASL NApoli 2 Nord, Naples.

Human and animal rights

All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. This article does not contain any studies with animals performed by any of the authors.

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Informed consent was obtained from all individual participants included in the study.

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Pizza, F., D’Antonio, D., Arcopinto, M. et al. Safety and efficacy of prophylactic resorbable biosynthetic mesh following midline laparotomy in clean/contemned field: preliminary results of a randomized double blind prospective trial. Hernia 24, 85–92 (2020).

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  • Incisional hernia
  • Resorb able mesh
  • Prophylactic mesh