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. 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. 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. 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. The study was registered March 27, 2015 at www.clinicaltrials.gov as NCT02401334.

中文翻译：

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使用新型抗生素浸渍的生物猪粘膜下层组织基质对感染疝气进行单阶段修复。

当使用生物移植物进行修复时，对污染区域的切口疝进行单阶段修复的手术部位感染率很高（30-42％）。为了降低这种风险，开发了一种将庆大霉素掺入衍生自猪小肠粘膜下层的生物细胞外基质的新型移植物。这项前瞻性，多中心，单臂观察性研究旨在确定将设备植入特征为CDC II，III或IV级的手术区域后，手术部位感染的发生率。入选了24例患者，其中42％被污染，而25％是肮脏的手术区域。12个月后，有5位患者经历了6次手术部位感染（21％），其中2位患者（8％）涉及移植物感染。没有移植移植物。对于在污染环境中进行腹疝的单阶段修复的患者，在没有明显的庆大霉素毒性和低设备感染率的情况下，可以实现将庆大霉素掺入猪源性生物移植物中。该研究于2015年3月27日在www.clinicaltrials.gov上注册为NCT02401334。