CTRI/2021/12/038884已完成4 期
A single blind, single centre, randomized, comparative study to assess the safety and effectiveness of Trushield NXT Non-Adherent Wound Dressing versus Tegaderm HPPad Film Dressing with Non-Adherent Pad in post-operative wound management of Obstetric and Gynecological surgeries
Father Muller Medical College1 个研究点 分布在 1 个国家目标入组 102 人开始时间: 2021年12月27日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- To assess effectiveness of Trushield NXT Non adherent wound dressing Versus Tegaderm HP+Pad Film Dressing with Non-Adherent Pad in post-operative wound management of obstetric and gynecological surgeries
研究概览
简要总结
This study aims to compare the efficacy and safety of two non-adherentsurgical wound dressings; TrushieldNXT Non adherent wound dressing developed by HealthiumMedtech Limited in comparison with Tegaderm HP+Pad Film Dressing withNon-Adherent Pad developed by 3M. Both the dressings are approved for usage inIndia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Permuted block randomization, variable
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- Female
入选标准
- •Women of age 18 – 65 years
- •Subject undergoing uncomplicated open obstetric/gynecological surgery in the opinion of the investigator
- •Subject with Hb ≥ 9gm/dl
- •Subject ready to give written consent for the study.
排除标准
- •Subject with condition/comorbidity that could compromise wound healing, including eczema, peripheral vascular disease, receiving immunosuppressive, high dose corticosteroid medications, corticosteroid abuse, and having uncontrolled diabetes
- •Subject with a systemic infection not controlled by suitable antibiotic treatment
- •Subject with an active neoplastic condition, treated by radiotherapy, chemotherapy, hormone therapy or immunosuppressant agents
- •Subject participating in another clinical study less than 30 days before participation in this study
- •Investigator’s discretion.
结局指标
主要结局
To assess effectiveness of Trushield NXT Non adherent wound dressing Versus Tegaderm HP+Pad Film Dressing with Non-Adherent Pad in post-operative wound management of obstetric and gynecological surgeries
时间窗: Day 0, 3, 10 and 35
次要结局
- 1. To evaluate post-operative wound complications(2. To evaluate scar cosmesis)
研究者
研究点 (1)
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