DeNoto George, Ceppa Eugene P, Pacella Salvatore J, Sawyer Michael, Slayden Geoffrey, Takata Mark, Tuma Gary, Yunis Jonathan
Department of General Surgery, St. Francis Hospital, Roslyn, NY 11576, USA.
Department of Surgery, Indiana University School of Medicine, Indianapolis, IN 46202, USA.
J Clin Med. 2021 Oct 27;10(21):4998. doi: 10.3390/jcm10214998.
Conflicting results from previous studies have led to dissent over whether surgical mesh is safe and effective in ventral hernia repair. A newer class of mesh known as a reinforced tissue matrix, combining a biologic scaffold and minimal polymer reinforcement, offers promise in reducing inflammatory response and increasing abdominal wall support. This study sought to assess the clinical utility of a reinforced tissue matrix (OviTex) in ventral hernia repair 12 months after implantation.
This is a prospective, single-arm, multi-center study to evaluate the clinical performance of OviTex 1S Permanent (OviTex) in the repair of primary or recurrent ventral hernias (VH) in consecutive patients (ClinicalTrials.gov/NCT03074474). The rate of surgical site occurrences (SSOs) was evaluated 90 days post-surgery as the primary endpoint. Hernia recurrence and the incidence of postoperative events were evaluated between three and 12 months as secondary endpoints. The incidence of other complications and patient-reported outcomes were also recorded.
Ninety-two (92) patients were enrolled in the study, of whom seventy-six (76) reached the 12-month follow-up. All patients were at least 18 years of age with a BMI of <40 kg/m. Hernia defects were <20 × 20 cm, classified as class I-III according to the CDC wound classification system. Of the 76 patients who reached 12-month follow-up, twenty-six (34%) had previous VH repairs and thirteen (17%) had previous surgical infection. Sixty (79%) had factors known to increase the risk of recurrence. Twenty patients (26%) experienced SSOs, with ten (13%) requiring procedural intervention. Two of the 75 patients (2.7%) experienced a recurrence.
The low rate of hernia recurrence and SSOs requiring intervention illustrates the potential that reinforced tissue matrices, and OviTex 1S, in particular, have to improve outcomes in VH repairs. Follow-up to 24 months is ongoing.
既往研究结果相互矛盾，导致对于手术补片在腹疝修补术中是否安全有效存在分歧。一种新型补片，即强化组织基质，它结合了生物支架和最少的聚合物强化成分，有望减少炎症反应并增强腹壁支撑力。本研究旨在评估强化组织基质（OviTex）在植入12个月后用于腹疝修补术的临床效用。
这是一项前瞻性、单臂、多中心研究，旨在评估OviTex 1S Permanent（OviTex）在连续患者原发性或复发性腹疝（VH）修补术中的临床表现（ClinicalTrials.gov/NCT03074474）。术后90天评估手术部位事件（SSO）发生率作为主要终点。在3至12个月期间评估疝复发情况和术后事件发生率作为次要终点。还记录了其他并发症的发生率以及患者报告的结果。
92例患者纳入本研究，其中76例完成了12个月的随访。所有患者年龄至少18岁，体重指数<40kg/m。疝缺损<20×20cm，根据疾病预防控制中心伤口分类系统分为I - III级。在完成12个月随访的76例患者中，26例（34%）既往有腹疝修补史，13例（17%）既往有手术感染史。60例（79%）有已知会增加复发风险的因素。20例患者（26%）发生了手术部位事件，其中10例（13%）需要进行手术干预。75例患者中有2例（2.7%）出现复发情况。
疝复发率低以及需要干预的手术部位事件发生率低，说明了强化组织基质，尤其是OviTex 1S，在改善腹疝修补术结局方面的潜力。正在进行至24个月的随访。
