Application of the Self-Assembling Peptide Hydrogel RADA16 for Hemostasis during Tonsillectomy: A Feasibility Study.

IF 5 3区 医学 Q1 ENGINEERING, BIOMEDICAL Journal of Functional Biomaterials Pub Date : 2024-09-18 DOI:10.3390/jfb15090271
Joshua Michaels, Anna I Kaleva, Laura Bateman, Oliver Wakelam, Joanna Stephens
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Abstract

Tonsillectomy is a common surgical procedure but carries a high risk of readmission for secondary bleeding and pain. This study evaluated the feasibility and effectiveness of using the hemostatic self-assembling peptide hydrogel RADA16 (PuraBond, 3-D Matrix SAS; Caluire et Cuire, France) to control bleeding from the tonsillectomy wound bed. Readmission/re-operation rates were compared between a prospective case series of 21 primarily adult tonsillectomy patients treated with topical RADA16 and an untreated historical Control group of 164 patients who underwent tonsillectomy by 10 surgeons at a single tertiary hospital in the UK between March 2019 and June 2022. Cumulative readmission rates for any reason were 2-fold elevated in Control subjects (18.9%; n = 31/164 subjects) compared to patients treated intra-operatively with RADA16 hemostatic hydrogel (9.5%; n = 2/21) (p = 0.378). Readmission rates for postoperative bleeding were 3-fold higher in Controls (14.6%; n = 24/164 subjects) than in the RADA16-treated group (4.8%; n = 1/21) (p = 0.317). A similar rate of retreatment for pain was recorded in the Control (4.3%; n = 7/164) and RADA16 (4.8%; n = 1/21) groups (p = 0.999). Two Control subjects (1.2%) required re-operation for recalcitrant bleeding; no RADA16 subject (0.0%) required re-operation for any reason. No device-related adverse events occurred in the RADA16 group. Surgeons were pleased with the easy learning curve and technical feasibility associated with intra-operatively administering RADA16 hemostatic hydrogel. Intra-operative hemostasis using RADA16 peptide hydrogel was straightforward and was associated with a trend of 3-fold lower rates of readmission for postoperative bleeding events than untreated Control subjects.

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应用自组装多肽水凝胶 RADA16 在扁桃体切除术中止血:可行性研究
扁桃体切除术是一种常见的外科手术,但因继发性出血和疼痛而再次入院的风险很高。本研究评估了使用止血自组装肽水凝胶 RADA16(PuraBond,3-D Matrix SAS;法国 Caluire et Cuire)控制扁桃体切除术伤口床出血的可行性和有效性。前瞻性病例系列包括 21 名接受局部 RADA16 治疗的成人扁桃体切除术患者,未接受治疗的历史对照组包括 164 名患者,这些患者于 2019 年 3 月至 2022 年 6 月期间在英国一家三甲医院接受了由 10 名外科医生主刀的扁桃体切除术。与术中接受 RADA16 止血水凝胶治疗的患者(9.5%;n = 2/21)相比,对照组患者因任何原因的累计再入院率(18.9%;n = 31/164)高出 2 倍(p = 0.378)。对照组术后出血再入院率(14.6%;n = 24/164)是 RADA16 治疗组(4.8%;n = 1/21)的 3 倍(p = 0.317)。对照组(4.3%;n = 7/164)和 RADA16 治疗组(4.8%;n = 1/21)的疼痛再治疗率相似(p = 0.999)。两名对照组受试者(1.2%)因顽固性出血需要再次手术;没有一名 RADA16 受试者(0.0%)因任何原因需要再次手术。RADA16 组未发生与设备相关的不良事件。外科医生对术中使用 RADA16 止血水凝胶的易学性和技术可行性表示满意。使用 RADA16 多肽水凝胶进行术中止血非常简单,而且术后出血事件的再入院率比未经处理的对照组低 3 倍。
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来源期刊
Journal of Functional Biomaterials
Journal of Functional Biomaterials Engineering-Biomedical Engineering
CiteScore
4.60
自引率
4.20%
发文量
226
审稿时长
11 weeks
期刊介绍: Journal of Functional Biomaterials (JFB, ISSN 2079-4983) is an international and interdisciplinary scientific journal that publishes regular research papers (articles), reviews and short communications about applications of materials for biomedical use. JFB covers subjects from chemistry, pharmacy, biology, physics over to engineering. The journal focuses on the preparation, performance and use of functional biomaterials in biomedical devices and their behaviour in physiological environments. Our aim is to encourage scientists to publish their results in as much detail as possible. Therefore, there is no restriction on the length of the papers. The full experimental details must be provided so that the results can be reproduced. Several topical special issues will be published. Scope: adhesion, adsorption, biocompatibility, biohybrid materials, bio-inert materials, biomaterials, biomedical devices, biomimetic materials, bone repair, cardiovascular devices, ceramics, composite materials, dental implants, dental materials, drug delivery systems, functional biopolymers, glasses, hyper branched polymers, molecularly imprinted polymers (MIPs), nanomedicine, nanoparticles, nanotechnology, natural materials, self-assembly smart materials, stimuli responsive materials, surface modification, tissue devices, tissue engineering, tissue-derived materials, urological devices.
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