CTRI/2024/07/070088招募中不适用
Evaluation of the comparative efficacy of an Ayurvedic polyherbal ointment vs Povidone iodine ointment in the management of postoperative proctology wounds A RCT
Dr Sreedevi V1 个研究点 分布在 1 个国家目标入组 166 人开始时间: 2024年7月15日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 166
- 试验地点
- 1
- 主要终点
- Pain, healing,
研究概览
简要总结
This study is designed as a randomised controlled , patient blinded, single centric, superiority study with two parallel groups and a primary end point of pain reduction and wound healing on 26 days after proctology surgery. Randomisation will be performed with a 1:1 allocation
Need for the study
A simple cost effective feasible topical application to reduce pain and promote post-operative
proctological wound healing which can exponentially reduce the chances of surgical site infection and
impact of prolonged hospital stay with increase in QOL in post- surgical patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients who can give written informed consent for the clinical trial Wounds acquired during surgical procedures of proctological disease Fissurectomy, low anal fistulotomy, external haemorroidectomy, sentinel tag excision Class II clean-contaminated wounds Patient having post-operative wounds of duration less than 6hrs Size Maximum Length Maximum Width Maximum Depth 4 cms (L) 4 cms (W)1 cms (D).
排除标准
- •Patients with post-surgical wounds of duration more than 6 hrs and > 4X4X1 cm 3 Wounds with signs of infection – Redness around, increased skin temperature, swelling, fever Known Diabetic patients, TB, HTN, HIV, Cancer patients Post-operative wounds having medico-legal problems.
- •Post-operative wounds of pediatric and (below 18 yrs) pregnant patients, and of patients above the age of 60 yrs.
- •Confounders to wound healing like habit of smoking, alcohol, those on medications like gluco corticoids, NSAIDS are excluded.
- •Patients who are not willing to participate in the trial.
结局指标
主要结局
Pain, healing,
时间窗: on the 0th day 5 days 7 days 14 th day 21 st day 28th day
次要结局
- tenderness wound healing assessments(oth day 5 th day 7 th day 14th day 21st day 28th day)
研究者
Sreedevi V
Amrita School of Ayurveda
研究点 (1)
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