Efficacy of Customized Pressure-Guided Elastic Bandages in Preventing Postoperative Edema and Complications in Coronary Artery Bypass Graft (CABG) Patients: A Comparative Study of Compression Therapy and Standard Post-CABG Care.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 106
- 试验地点
- 2
- 主要终点
- incidence rate of leg swelling
研究概览
简要总结
The study aimed to assess the efficacy of customized pressure-guided elastic bandages (CPG-EB) in preventing postoperative edema and complications in Coronary Artery Bypass Graft (CABG) patients. While compression therapy, like compressive stockings, has benefits in preventing edema, concerns about affordability persist. CPG-EB provides optimal sub-bandage pressure, proven effective in venous leg ulcers. Implementing CPG-EB post-CABG could enhance venous blood flow, reducing complications and improving outcomes. Patients were divided into two groups: one with CPG-EB and the other standard post-CABG care. Data collected at 1, 2, and 6 weeks post-surgery assessed swelling and wound complications. Comparative analysis used standardized criteria.
详细描述
Inclusion Criteria :
- All patients scheduled for elective coronary artery bypass grafting (CABG) surgery with saphenous vein harvesting from the leg at Siriraj Hospital.
- Patients aged 18 years and older undergoing CABG surgery with saphenous vein harvesting from the leg at Siriraj Hospital, who willingly consent to participate in the study.
Exclusion Criteria : *
- Patients with an Ankle-brachial pressure index (ABI) < 0.8
- Patients with severe leg swelling (pitting edema of grade 3 or higher) or with pre-existing or post-operative heart failure that remains uncontrolled despite diuretic therapy.
- Patients with occlusive peripheral arterial disease (PAD) or chronic venous insufficiency (CEAP 2s), characterized by significant venous stasis, leg pain, varicose veins, or lymphadenopathy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All patients scheduled for elective coronary artery bypass grafting (CABG) surgery with saphenous vein harvesting from the leg at Siriraj Hospital.
- •Patients aged 18 years and older undergoing CABG surgery with saphenous vein harvesting from the leg at Siriraj Hospital, who willingly consent to participate in the study.
排除标准
- •Patients with an Ankle-brachial pressure index (ABI) < 0.8
- •Patients with severe leg swelling (pitting edema of grade 3 or higher) or with pre-existing or post-operative heart failure that remains uncontrolled despite diuretic therapy.
- •Patients with occlusive peripheral arterial disease (PAD) or chronic venous insufficiency (CEAP 2s), characterized by significant venous stasis, leg pain, varicose veins, or lymphadenopathy.
研究组 & 干预措施
CPG-EB group
The intervention group received Customized-pressure guided elastic bandage for 4 weeks post-operatively.
干预措施: CPG-EB group (Device)
Standard group
Standard group is the standard of care in post operative CABG surgery patients. This group used elastic bandage for 24 hours or overnight after surgery.
结局指标
主要结局
incidence rate of leg swelling
时间窗: 1, 2 and 6 weeks after CABG surgery
Chi-square test
Rate of severity level of swelling
时间窗: 1, 2 and 6 weeks after CABG surgery
Chi-square test
differences in leg circumference at various locations between preoperative and postoperative measurements between the two groups.
时间窗: 1, 2 and 6 weeks after CABG surgery
Independent sample t-test or Mann-Whitney U test
次要结局
- rate of numbness(1, 2 and 6 weeks after CABG surgery)
- infection rate(1, 2 and 6 weeks after CABG surgery)
- rate of delayed wound healing(1, 2 and 6 weeks after CABG surgery)
研究者
Ratcharnon Srifa
Ratcharnon Srifa, Cardiothoracic Resident, MD, Sub-Investigator, Cardiothoracic Division, Department of Surgery
Siriraj Hospital