Erasmus University Medical Centre Rotterdam, Department of Surgery, Rotterdam, The Netherlands.
Erasmus University Medical Centre Rotterdam, Department of Surgery, Rotterdam, The Netherlands.
Int J Surg. 2020 Nov;83:31-36. doi: 10.1016/j.ijsu.2020.08.053. Epub 2020 Sep 12.
Resorbable biomaterials have been developed to reduce the amount of foreign material remaining in the body after hernia repair over the long-term. However, on the short-term, these resorbable materials should render acceptable results with regard to complications, infections, and reoperations to be considered for repair. Additionally, the rate of resorption should not be any faster than collagen deposition and maturation; leading to early hernia recurrence. Therefore, the objective of this study was to collect data on the short-term performance of a new resorbable biosynthetic mesh (Phasix™) in patients requiring Ventral Hernia Working Group (VHWG) Grade 3 midline incisional hernia repair.
A prospective, multi-center, single-arm trial was conducted at surgical departments in 15 hospitals across Europe. Patients aged ≥18, scheduled to undergo elective Ventral Hernia Working Group Grade 3 hernia repair of a hernia larger than 10 cm were included. Hernia repair was performed with Phasix™ Mesh in sublay position when achievable. The primary outcome was the rate of surgical site occurrence (SSO), including infections, that required intervention until 3 months after repair.
In total, 84 patients were treated with Phasix™ Mesh. Twenty-two patients (26.2%) developed 32 surgical site occurrences. These included 11 surgical site infections, 9 wound dehiscences, 7 seromas, 2 hematomas, 2 skin necroses, and 1 fistula. No significant differences in surgical site occurrence development were found between groups repaired with or without component separation technique, and between clean-contaminated or contaminated wound sites. At three months, there were no hernia recurrences.
Phasix™ Mesh demonstrated acceptable postoperative surgical site occurrence rates in patients with a Ventral Hernia Working Group Grade 3 hernia. Longer follow-up is needed to evaluate the recurrence rate and the effects on quality of life. This study is ongoing through 24 months of follow-up.
可吸收生物材料的开发旨在减少疝修补术后长期体内残留的异物量。然而，在短期内，这些可吸收材料在并发症、感染和再次手术方面应能获得可接受的结果，以考虑进行修复。此外，吸收速度不应快于胶原沉积和成熟，以免导致早期疝复发。因此，本研究的目的是收集新型可吸收生物合成网（Phasix™）在需要 VHWG 3 级中线切口疝修复的患者中的短期表现数据。
在欧洲 15 家医院的外科部门进行了一项前瞻性、多中心、单臂试验。纳入年龄≥18 岁、计划行择期 VHWG 3 级疝修补术且疝大于 10cm 的患者。当可行时，采用 Phasix™网片在下方进行疝修补。主要结局是手术部位发生（SSO）的发生率，包括感染，需要在修复后 3 个月内进行干预。
共 84 例患者接受了 Phasix™网片治疗。22 例（26.2%）患者发生 32 例手术部位发生。其中包括 11 例手术部位感染、9 例伤口裂开、7 例血清肿、2 例血肿、2 例皮肤坏死和 1 例瘘管。未发现采用或不采用组件分离技术、清洁污染或污染伤口部位修复的患者手术部位发生的发展存在显著差异。3 个月时，无疝复发。
Phasix™网片在 VHWG 3 级疝患者中显示出可接受的术后手术部位发生率。需要更长时间的随访来评估复发率和对生活质量的影响。该研究正在进行中，随访时间为 24 个月。
