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

ABSTRACT: BACKGROUND: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. 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. METHODS:This 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. RESULTS:Twenty-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. CONCLUSIONS:The 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 REGISTRATION:The study was registered March 27, 2015 at www.clinicaltrials.gov as NCT02401334.

SUBMITTER: Minor S

PROVIDER: S-EPMC7106678 | biostudies-literature | 2020 Mar

REPOSITORIES: biostudies-literature

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

Minor Samuel S Brown Carl J CJ Rooney Paul S PS Hodde Jason P JP Julien Lisa L Scott Tracy M TM Karimuddin Ahmer A AA Raval Manoj J MJ Phang P Terry PT

BMC surgery 20200330 1

<h4>Background</h4>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. 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.<h4>Methods</h4>This prospective, multicenter, single-arm observational study was designed to determine the incidence of surgical site infection fol ...[more]

PMID: 32228664

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Project description:Controversy exists regarding the optimal treatment of periprosthetic joint infection (PJI), considering control of infection, functional results as well as quality of life. Difficulties in treatment derive from the formation of biofilms within a few days after infection. Biofilms are tolerant to systemically applied antibiotics, requiring extreme concentrations for a prolonged period. Minimum biofilm eradicating concentrations (MBEC) are only feasible by the local application of antibiotics. One established approach is the use of allograft bone as a carrier, granting a sustained release of antibiotics in very high concentrations after appropriate impregnation. The purpose of this study was to determine the rate of reinfection after a one-stage revision of infected hip or knee prostheses, using antibiotic-impregnated allograft bone as the carrier and avoiding cement. Between 1 January 2004 and 31 January 2018, 87 patients with PJI, according to MSIS, underwent a one-stage revision with antibiotic-impregnated cancellous allograft bone. An amount of 17 patients had insufficient follow-ups. There were 70 remaining patients (34 male, 36 female) with a mean follow-up of 5.6 years (range 2-15.6) and with a mean age of 68.2 years (range 31.5-86.9). An amount of 38 hips and 11 knees were implanted without any cement; and 21 knees were implanted with moderate cementing at the articular surface with stems always being uncemented. Within 2 years after surgery, 6 out of 70 patients (8.6%, CI 2-15.1) showed reinfection and after more than 2 years, an additional 6 patients showed late-onset infection. Within 2 years after surgery, 11 out of 70 patients (15.7%, CI 7.2-24.2) had an implant failure for any reason (including infection) and after more than 2 years, an additional 7 patients had an implant failure. Using Kaplan-Meier analysis for all 87 patients, the estimated survival for reinfection was 93.9% (CI 88.8-99.1) at 1 year, 89.9% (CI 83.2-96.6) at 2 years and 81.5% (CI 72.1-90.9) at 5 years. The estimated survival for implant failure for any reason was 90.4% (CI 84.1-96.7) at 1 year, 80.9% (CI 72.2-89.7) at 2 years and 71.1% (CI 60.3-81.8) at 5 years. One-stage revision with antibiotic-impregnated cancellous allograft bone grants comparable results regarding infection control as with multiple stages, while shortening rehabilitation, improving quality of life for the patients and reducing costs for the health care system.

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Dataset Information

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

Publications

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

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