Department of General Surgery B and Transplantation, Sheba Medical Hospital Center, Tel Hashomer, Ramat Gan, Israel.
Department of Gastroenterology, Sheba Medical Center, Tel Hashomer, Ramat Gan, Israel.
Tech Coloproctol. 2024 Aug 13;28(1):97. doi: 10.1007/s10151-024-02973-9.
PNS is caused by an infection in the sacrococcygeal area triggered by hair particle accumulation in skin tunnels, resulting in infection. Surgical options range from simple excision to complex flap constructions. Primary wound healing failure and recurrence rates contribute to the burden of PNS. RD2 Ver.02, a novel autologous whole-blood clot product, demonstrated safety and efficacy in treating complex cutaneous wounds and was investigated for the management of PNS.
A Phase II open-label, pilot, single-arm prospective study was conducted from May 2021 to May 2023 (Ethics Committee approval #7952-20). Patients with PNS underwent a minimally invasive trephine procedure under local anesthesia followed by RD2 Ver.02 instillation into the cavity. Primary healing was assessed at 3, 6, and 12 months. Secondary outcomes included the collection of adverse events.
Overall, 51 patients participated in the study. At 3 months, 42/51 healed (82.4%), 7/51 (13.7%) were granulating but not completely healed, and 2/51 (3.9%) failed to heal. At 6 and 12 months, 46/51 (90.2%) and 42/51 (82.4%) achieved complete healing, respectively. At 6 months, two PNSs recurred after initial healing and an additional four instances of PNS recurrence observed in 12 months, so a total of recurrence in six patients (11.8%). There were five adverse events (AEs) with no severe adverse events.
RD2 Ver.02 is a safe and effective treatment of PNS when coupled with a minimally invasive trephine PNS procedure. Further comparative studies are needed to fully assess the role of this novel therapy for PNS.
PNS 是由尾骨区域的感染引起的，感染是由皮肤隧道中的毛发颗粒积聚引起的。手术选择范围从简单的切除到复杂的皮瓣构建。原发性伤口愈合失败和复发率是 PNS 的负担。RD2 Ver.02 是一种新型的自体全血凝块产品，已被证明在治疗复杂皮肤伤口方面的安全性和有效性，并被用于治疗 PNS。
一项为期 24 个月的、开放标签、前瞻性单臂研究（伦理委员会批准号：7952-20）于 2021 年 5 月至 2023 年 5 月进行。患有 PNS 的患者在局部麻醉下接受微创环钻手术，然后将 RD2 Ver.02 注入空腔。在 3、6 和 12 个月时评估原发性愈合。次要结局包括不良事件的收集。
共有 51 名患者参与了该研究。在 3 个月时，42/51 例患者治愈（82.4%），7/51 例（13.7%）仍在肉芽期但未完全愈合，2/51 例（3.9%）未愈合。在 6 个月和 12 个月时，分别有 46/51（90.2%）和 42/51（82.4%）完全愈合。在 6 个月时，有 2 例 PNS 在初始愈合后复发，在 12 个月时又有 4 例 PNS 复发，因此共有 6 例患者（11.8%）复发。共有 5 例不良事件（AE），无严重不良事件。
RD2 Ver.02 与微创环钻 PNS 手术联合治疗 PNS 安全有效。需要进一步的比较研究来充分评估这种新型疗法在 PNS 中的作用。
