Efficacy and safety of RD2 Ver.02, a whole blood clot therapy, coupled with a minimally invasive procedure in pilonidal sinus: a phase II study.

IF 2.7 3区医学 Q2 GASTROENTEROLOGY & HEPATOLOGY Techniques in Coloproctology Pub Date : 2024-08-13 DOI:10.1007/s10151-024-02973-9

E Ram, Y Zager, D Carter, R Anteby, J Haik, I Nachmany, N Horesh

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Abstract

Background: 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.

Methods: 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.

Results: 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.

Conclusion: 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.

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RD2 Ver.02全血凝块疗法与微创手术相结合治疗朝天鼻窦的有效性和安全性：II期研究。

背景：PNS 是由于毛发颗粒堆积在皮肤隧道中引发骶尾部感染，从而导致感染。手术方案从简单的切除到复杂的皮瓣构建不一而足。原发性伤口愈合失败和复发率增加了 PNS 的负担。RD2 Ver.02是一种新型自体全血凝块产品，在治疗复杂皮肤伤口方面具有安全性和有效性，因此被研究用于治疗PNS：2021 年 5 月至 2023 年 5 月期间进行了一项开放标签、试验性、单臂前瞻性 II 期研究（伦理委员会批准号：7952-20）。PNS患者在局部麻醉下接受微创穿刺手术，然后向腔内灌注RD2 Ver.02。在 3 个月、6 个月和 12 个月时评估初次愈合情况。次要结果包括不良事件的收集：共有 51 名患者参与了研究。3 个月时，42/51 例（82.4%）痊愈，7/51 例（13.7%）已长出肉芽但未完全愈合，2/51 例（3.9%）未能痊愈。在 6 个月和 12 个月时，分别有 46/51 例（90.2%）和 42/51 例（82.4%）达到完全愈合。在 6 个月时，2 例 PNS 在初步愈合后复发，另外 4 例 PNS 在 12 个月时复发，因此共有 6 例患者（11.8%）复发。共有五例不良反应（AE），无严重不良反应：结论：RD2 Ver.02结合微创穿刺PNS手术是一种安全有效的PNS治疗方法。要全面评估这种新型疗法对 PNS 的作用，还需要进一步的比较研究。

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来源期刊

Techniques in Coloproctology GASTROENTEROLOGY & HEPATOLOGY-SURGERY

CiteScore

5.30

自引率

9.10%

发文量

176

审稿时长

1 months

期刊介绍： Techniques in Coloproctology is an international journal fully devoted to diagnostic and operative procedures carried out in the management of colorectal diseases. Imaging, clinical physiology, laparoscopy, open abdominal surgery and proctoperineology are the main topics covered by the journal. Reviews, original articles, technical notes and short communications with many detailed illustrations render this publication indispensable for coloproctologists and related specialists. Both surgeons and gastroenterologists are represented on the distinguished Editorial Board, together with pathologists, radiologists and basic scientists from all over the world. The journal is strongly recommended to those who wish to be updated on recent developments in the field, and improve the standards of their work. Manuscripts submitted for publication must contain a statement to the effect that all human studies have been reviewed by the appropriate ethics committee and have therefore been performed in accordance with the ethical standards laid down in an appropriate version of the 1965 Declaration of Helsinki. It should also be stated clearly in the text that all persons gave their informed consent prior to their inclusion in the study. Details that might disclose the identity of the subjects under study should be omitted. Reports of animal experiments must state that the Principles of Laboratory Animal Care (NIH publication no. 86-23 revised 1985) were followed as were applicable national laws (e.g. the current version of the German Law on the Protection of Animals). The Editor-in-Chief reserves the right to reject manuscripts that do not comply with the above-mentioned requirements. Authors will be held responsible for false statements or for failure to fulfill such requirements.