Early Clinical Outcomes of a Novel Antibiotic-Coated, Non-Crosslinked Porcine Acellular Dermal Graft after Complex Abdominal Wall Reconstruction

Baker, E.; Lepere, Darren; Lundgren, Megan; Greaney, Patrick J.; Copit, Steven E.; Murphree, A L; Canfield, Anthony J.; Parker, Glenn; Iannitti, David A.

doi:10.1016/j.jamcollsurg.2016.05.022

Cited by 19 publications

(20 citation statements)

References 13 publications

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“…Deep surgical site infection directly involving the AHRD was located was less frequent than what has been previously described for non-antibiotic impregnated biologic grafts when placed in patients at high risk of infection. This finding closely mirrors the findings of a single arm study using a rifampin/minocycline-coated, non-crosslinked porcine acellular dermis, in which implant of the device in complex abdominal wall reconstruction patients was associated with a low 30-day rate of postoperative surgical site occurrences/postoperative complications [21]. Table 5 summarizes studies utilizing biologic grafts in single-stage repair in contaminated fields and describes infection rates 2 to 3 times higher than what was observed in the current study.…”

Section: Discussionsupporting

confidence: 83%

“…In their conclusions, Helton et al [11] recommended that because of the high rate of infection observed in contaminated fields, the fascia should not be closed primarily over SIS to avoid a closed space infection. Because bridged repairs are associated with an increased risk of recurrence, the current study protocol required the graft to be covered primarily with fascia; despite this, a lower rate of graft infection was observed as compared to rates reported previously [11,19,21].…”

Section: Discussionmentioning

confidence: 94%

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Single-Stage Repair of Contaminated Hernias Using a Novel Antibiotic-Impregnated Biologic Porcine Submucosa Tissue Matrix

Minor

Brown

Rooney

et al. 2019

Preprint

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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 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 is associated with a lower than expected 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.

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Section: Discussionsupporting

confidence: 83%

Section: Discussionmentioning

confidence: 94%

Single-Stage Repair of Contaminated Hernias Using a Novel Antibiotic-Impregnated Biologic Porcine Submucosa Tissue Matrix

Minor

Brown

Rooney

et al. 2019

Preprint

View full text Add to dashboard Cite

show abstract

“…Deep surgical site infection directly involving the AHRD is not consistent with what has been previously described for non-antibiotic impregnated biologic grafts when placed in patients at high risk of infection. However, this finding closely mirrors the findings of a single arm study using a rifampin/minocycline-coated, non-crosslinked porcine acellular dermis, in which implant of the device in complex abdominal wall reconstruction patients was associated with a low 30-day rate of postoperative surgical site occurrences/postoperative complications [21]. Table 4 summarizes studies utilizing biologic grafts in single-stage repair in contaminated fields and describes infection rates 2 to 3 times higher than what was observed in the current study.…”

Section: Discussionsupporting

confidence: 80%

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

et al. 2020

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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.

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“…Our previous in vitro experiments have shown that other drugs can be loaded in the HApN hydrogel, like gentamicin or even chlorhexidine [15]. Antibiotic and antiseptic-coated meshes are available in clinics for complex abdominal wall hernia repairs with high risk of developing infection (e.g., DualMesh Plus from W. L. Gore & Associates, Inc., Newark, DE, USA, or XenMatrix AB from C. R. Bard, Inc., Murray Hill, NJ, USA) [30][31][32]. Nevertheless, their clinical utilization is extremely restricted due to issues in terms of cost, limited choice of loaded drugs (grafts available with rifampicin and minocycline or chlorhexidine and silver) and limited choice in terms of mesh substrates [9].…”

Section: Discussionmentioning

confidence: 99%

Thermo-Responsive Antimicrobial Hydrogel for the In-Situ Coating of Mesh Materials for Hernia Repair

et al. 2020

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The prophylactic coating of prosthetic mesh materials for hernia repair with antimicrobial compounds is commonly performed before implantation of the mesh in the abdominal wall. We propose a novel alternative, which is a rifampicin-loaded thermo-responsive hydrogel formulation, to be applied on the mesh after its implantation. This formulation becomes a gel in-situ once reached body temperature, allowing an optimal coating of the mesh along with the surrounding tissues. In vitro, the hydrogel cytotoxicity was assessed using rabbit fibroblasts and antimicrobial efficacy was determined against Staphylococcus aureus. An in vivo rabbit model of hernia repair was performed; implanted polypropylene meshes (5 × 2 cm) were challenged with S. aureus (106 CFU), for two study groups—unloaded (n = 4) and 0.1 mg/cm2 rifampicin-loaded hydrogel (n = 8). In vitro, antibacterial activity of the hydrogel lasted for 5 days, without sign of cytotoxicity. Fourteen days after implantation, meshes coated with drug-free hydrogel developed a strong infection and resulted in poor tissue integration. Coating meshes with the rifampicin-loaded hydrogel fully prevented implant infection and permitted an optimal tissue integration. Due to its great performance, this, degradable, thermo-responsive antimicrobial hydrogel could potentially be a strong prophylactic armamentarium to be combined with prosthesis in the surgical field.

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Early Clinical Outcomes of a Novel Antibiotic-Coated, Non-Crosslinked Porcine Acellular Dermal Graft after Complex Abdominal Wall Reconstruction

Cited by 19 publications

References 13 publications

Single-Stage Repair of Contaminated Hernias Using a Novel Antibiotic-Impregnated Biologic Porcine Submucosa Tissue Matrix

Single-Stage Repair of Contaminated Hernias Using a Novel Antibiotic-Impregnated Biologic Porcine Submucosa Tissue Matrix

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

Thermo-Responsive Antimicrobial Hydrogel for the In-Situ Coating of Mesh Materials for Hernia Repair

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