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MITSU AB™ 三氯生涂层缝线预防手术部位感染的有效性和安全性

Efficacy and Safety of MITSU AB™ Triclosan-Coated Sutures in Preventing Surgical Site Infections.

作者信息

Galam Pushkar, Desai Yogesh, Patel Army, Bajpayee Lalit, Kumar Shetty Kiran

机构信息

Surgery, Hope Hospital, Pune, IND.

Obstetrics and Gynecology, Shanti Hospital, Udvada, IND.

出版信息

Cureus. 2025 May 16;17(5):e84246. doi: 10.7759/cureus.84246. eCollection 2025 May.

DOI:10.7759/cureus.84246
PMID:40525068
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12168879/
Abstract

INTRODUCTION

Surgical site infections (SSIs) are a significant source of postoperative morbidity. Triclosan-coated absorbable sutures, such as MITSU AB™ (Meril Endo Surgery Private Limited, Vapi, India), are designed to inhibit early microbial colonization, reducing the risk of SSIs. However, concerns about triclosan resistance highlight the need for real-world clinical evaluation. The present study aims to assess wound healing outcomes, incidence of SSIs, and triclosan resistance in patients treated with MITSU AB™ absorbable triclosan-coated sutures.

METHODS

A prospective, single-arm, multi-center post-marketing surveillance study was conducted involving 60 patients undergoing general surgical procedures, including laparoscopic appendectomy, episiotomy, and soft tissue repair. Patients were monitored postoperatively at discharge and days 7, 15, and 30. Primary outcomes included SSI occurrence and triclosan resistance. Secondary endpoints were wound healing grade, pain (measured by visual analogue scale (VAS)), and suture handling feedback.

RESULTS

The study population had a mean age of 38.5 ± 17.4 years, with 36 (60%) female participants. All patients (100%) achieved complete wound healing (Grade A) by day 30. No SSIs, triclosan-resistant microbial growth, or adverse events were recorded. Pain scores decreased over time, with 59 (98.3%) patients pain-free by day 15 and 100% by day 30. Suture handling was rated excellent in 51 (85%) cases. No re-interventions or re-admissions due to infection occurred during the study.

CONCLUSION

MITSU AB™ triclosan-coated sutures demonstrated excellent infection prevention, complete healing, and favorable handling with no evidence of triclosan resistance. These findings support their safe and effective use in clinical surgery.

摘要

引言

手术部位感染(SSIs)是术后发病的一个重要来源。含三氯生的可吸收缝线,如MITSU AB™(印度瓦皮市梅里尔内镜外科私人有限公司),旨在抑制早期微生物定植,降低手术部位感染的风险。然而,对三氯生耐药性的担忧凸显了进行实际临床评估的必要性。本研究旨在评估使用MITSU AB™含三氯生可吸收缝线治疗的患者的伤口愈合结果、手术部位感染发生率和三氯生耐药性。

方法

进行了一项前瞻性、单臂、多中心上市后监测研究,纳入60例接受普通外科手术的患者,包括腹腔镜阑尾切除术、会阴切开术和软组织修复术。患者在出院时以及术后第7天、15天和30天接受监测。主要结局包括手术部位感染的发生情况和三氯生耐药性。次要终点为伤口愈合等级、疼痛(采用视觉模拟评分法(VAS)测量)和缝线操作反馈。

结果

研究人群的平均年龄为38.5±17.4岁,女性参与者有36名(60%)。所有患者(100%)在第30天时实现了完全伤口愈合(A级)。未记录到手术部位感染、三氯生耐药微生物生长或不良事件。疼痛评分随时间下降,59名(98.3%)患者在第15天时无疼痛,第30天时100%无疼痛。51例(85%)患者对缝线操作的评价为优秀。研究期间未发生因感染导致的再次干预或再次入院情况。

结论

MITSU AB™含三氯生缝线在预防感染方面表现出色,实现了完全愈合,操作良好,且没有三氯生耐药性的证据。这些发现支持其在临床手术中的安全有效应用。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/167e/12168879/91dcb3a7f8bb/cureus-0017-00000084246-i04.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/167e/12168879/b92bb2ee38ce/cureus-0017-00000084246-i01.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/167e/12168879/d2dca1eea226/cureus-0017-00000084246-i02.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/167e/12168879/d44a424da5dd/cureus-0017-00000084246-i03.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/167e/12168879/91dcb3a7f8bb/cureus-0017-00000084246-i04.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/167e/12168879/b92bb2ee38ce/cureus-0017-00000084246-i01.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/167e/12168879/d2dca1eea226/cureus-0017-00000084246-i02.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/167e/12168879/d44a424da5dd/cureus-0017-00000084246-i03.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/167e/12168879/91dcb3a7f8bb/cureus-0017-00000084246-i04.jpg

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