Prabha Shankar Amritha, Br Kiran Kumar, Shankar Bharat, Babu Ravoori H, Dholariya Rahul, Muralidhar Shubhashree, Subramanya Ganesh M
Surgical Oncology, Vydehi Institute of Medical Sciences and Research Centre, Bengaluru, IND.
Radiation Oncology, Vydehi Institute of Medical Sciences and Research Centre, Bengaluru, IND.
Cureus. 2024 Mar 20;16(3):e56593. doi: 10.7759/cureus.56593. eCollection 2024 Mar.
Background Oncological surgeries pose an elevated risk of surgical site infections (SSIs) due to their complexity and various associated treatments, impacting patient outcomes and healthcare costs. This has prompted a focus on advanced wound dressings that provide microbial protection, exudate absorption, and improved product performance, enhancing patient satisfaction. Our study aimed to compare the efficacy and safety of Theruptor NXT with the current standard of care (SOC) practice involving cotton/povidone/micropore dressings in the postoperative wound management of oncological surgeries. Methodology A total of 102 patients who underwent oncological surgeries in the Department of Surgical Oncology, Vydehi Institute of Medical Sciences and Research Centre, Bengaluru, India between May and September 2023 were randomized to Theruptor NXT and SOC dressing groups (51 patients each). The incidence of SSIs, wound pain score, cosmetic appearance of the wound, and adverse events were assessed in the two groups at various intervals, i.e., post-surgery day 2 ± 1, day of discharge, and post-surgery day 30 ± 7. Further, the subject satisfaction and product usage were evaluated on post-surgery day 2 ± 1. Results The baseline characteristics were found to be comparable in both groups, i.e., Theruptor NXT and SOC groups. Further, the SSI rates, scar outcomes, and physiological parameters were also similar between the Theruptor NXT and SOC groups, indicating a similar safety profile of both dressings (p > 0.05). However, the product usage assessment revealed statistically significant differences, favoring Theruptor NXT in terms of superior ease of application, stretchability, exudate management, breathability, and non-adherence properties (p < 0.05). Conclusions Our findings suggest that Theruptor NXT wound dressing is a promising, effective, and user-friendly alternative to SOC wound dressing in diverse clinical settings.
背景 肿瘤手术因其复杂性和各种相关治疗而导致手术部位感染（SSI）的风险升高，这会影响患者的治疗结果和医疗成本。这促使人们关注先进的伤口敷料，这些敷料可提供微生物防护、渗出液吸收并改善产品性能，从而提高患者满意度。我们的研究旨在比较Theruptor NXT与当前标准护理（SOC）方法（涉及在肿瘤手术的术后伤口管理中使用棉花/聚维酮/微孔敷料）的疗效和安全性。
方法 2023年5月至9月期间，在印度班加罗尔的维迪希医学科学与研究中心外科肿瘤学系接受肿瘤手术的102例患者被随机分为Theruptor NXT组和SOC敷料组（每组51例患者）。在不同时间间隔，即术后第2±1天、出院日和术后第30±7天，评估两组的手术部位感染发生率、伤口疼痛评分、伤口外观以及不良事件。此外，在术后第2±1天评估患者满意度和产品使用情况。
结果 发现两组（即Theruptor NXT组和SOC组）的基线特征具有可比性。此外，Theruptor NXT组和SOC组之间的手术部位感染率、瘢痕结果和生理参数也相似，表明两种敷料的安全性相似（p>0.05）。然而，产品使用评估显示出统计学上的显著差异，Theruptor NXT在应用简便性、拉伸性、渗出液管理、透气性和非粘连性方面更具优势（p<0.05）。
结论 我们的研究结果表明，在不同的临床环境中，Theruptor NXT伤口敷料是一种有前景、有效且用户友好的SOC伤口敷料替代品。
