临床试验/CTRI/2025/02/080791

CTRI/2025/02/080791尚未招募1 期

Effectiveness of incisional negative pressure wound therapy to reduce serous drainage following modified radical mastectomy in breast cancer patients: A randomised controlled trial.

AIIMS Jodhpur1 个研究点分布在 1 个国家目标入组 98 人开始时间: 2025年2月28日最近更新: 2025年2月16日

试验速览

阶段: 1 期
状态: 尚未招募
发起方: AIIMS Jodhpur
入组人数: 98
试验地点: 1
主要终点: Reduction in serous discharge after MRM.

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This study is designed to compare effectiveness of incisional negative pressure wound therapy to reduce postoperative seroma in the patients undergoing modified radical mastectomy for breast cancer. If statistically significant results are found, then application of incisional negative pressure wound therapy might be used as standard procedure to reduce postoperative complications of modified radical mastectomy.

研究设计

研究类型: Interventional
分配方式: Randomized
盲法: None

入排标准

年龄范围: 18.00 Year(s) 至 99.00 Year(s)（—）
性别: All

入选标准

•All female patients with the diagnosis of breast cancer planned for Modified Radical Mastectomy (MRM) in the Department of General Surgery and Department of Surgical Oncology at All India Institute of Medical Sciences, Jodhpur.

排除标准

•Patients planned for breast reconstructive surgery Patients on Anticoagulants (Acitrom, Warfarin, Dabigatran) Patients on chemotherapy for non-breast malignancy Patients with diagnosis of unstable medical diseases (cardiac diseases, liver diseases, kidney diseases).

结局指标

主要结局

Reduction in serous discharge after MRM.

时间窗: POD1,2,3,7,10

次要结局

Reduction in flap necrosis, wound infection, wound dehicence.(4 weeks, 8 weeks)

研究者

发起方

AIIMS Jodhpur

申办方类型

Research institution

责任方

Principal Investigator

主要研究者

Dr Sanket Kevadiya

AIIMS Jodhpur

研究点 (1)

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