Single-stage repair of contaminated hernias using a novel antibiotic-impregnated biologic porcine submucosa tissue matrix

Manoj J Raval,Samuel Minor,Tracy M Scott,Carl J Brown,Lisa Julien,Ahmer A Karimuddin,Paul S Rooney,P Terry Phang,Jason P Hodde

doi:10.1186/s12893-020-00715-w

Abstract

BackgroundSingle-stage repair of incisional hernias in contaminated fields has a high rate of surgical site infection (30–42%) when biologic grafts are used for repair. In an attempt to decrease this risk, a novel graft incorporating gentamicin into a biologic extracellular matrix derived from porcine small intestine submucosa was developed.MethodsThis prospective, multicenter, single-arm observational study was designed to determine the incidence of surgical site infection following implantation of the device into surgical fields characterized as CDC Class II, III, or IV.ResultsTwenty-four patients were enrolled, with 42% contaminated and 25% dirty surgical fields. After 12 months, 5 patients experienced 6 surgical site infections (21%) with infection involving the graft in 2 patients (8%). No grafts were explanted.ConclusionsThe incorporation of gentamicin into a porcine-derived biologic graft can be achieved with no noted gentamicin toxicity and a low rate of device infection for patients undergoing single-stage repair of ventral hernia in contaminated settings.Trial registrationThe study was registered March 27, 2015 at www.clinicaltrials.gov as NCT02401334.

Highlights

Single-stage repair of incisional hernias in contaminated fields has a high rate of surgical site infection (30–42%) when biologic grafts are used for repair
We postulated that by incorporating gentamicin sulfate into a small intestinal submucosa (SIS) graft that we could protect it from bacterial colonization and prevent premature implant degradation secondary to bacterial protease activity
Patients with contaminated and dirty surgical fields comprised most of the cohort (Table 2), with one patient enrolled whose wound was reclassified to Class I after the procedure

Summary

Introduction

Single-stage repair of incisional hernias in contaminated fields has a high rate of surgical site infection (30–42%) when biologic grafts are used for repair. Surgical site infection (SSI) following synthetic mesh repair in contaminated fields is high, with rates of 30–42% being reported [1,2,3]. Expert consensus and several systematic reviews recommend the use of biologic grafts when the risk of surgical site events is high, such as in the presence of gross contamination, because infection of Porcine small intestinal submucosa (SIS) is a type of biologic hernia graft whose performance in contaminated settings have been previously described [20]. Minor et al BMC Surgery (2020) 20:58 a gentamicin sulfate-containing SIS hernia graft during the repair of incisional hernias in surgical fields characterized as Centers for Disease Control and Prevention (CDC) Classes II, III, or IV. Secondary outcomes included the rate of hernia recurrence and other clinical and patient-reported outcomes

Methods

Results

Conclusion