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临床试验/NCT06603961
NCT06603961
招募中
不适用

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.

Siriraj Hospital2 个研究点 分布在 1 个国家目标入组 106 人2025年1月19日

概览

阶段
不适用
干预措施
CPG-EB group
疾病 / 适应症
Limb Edema
发起方
Siriraj Hospital
入组人数
106
试验地点
2
主要终点
incidence rate of leg swelling
状态
招募中
最后更新
2个月前

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 : 1. All patients scheduled for elective coronary artery bypass grafting (CABG) surgery with saphenous vein harvesting from the leg at Siriraj Hospital. 2. 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 : \* 1. Patients with an Ankle-brachial pressure index (ABI) \< 0.8 2. 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. 3. Patients with occlusive peripheral arterial disease (PAD) or chronic venous insufficiency (CEAP 2s), characterized by significant venous stasis, leg pain, varicose veins, or lymphadenopathy.

注册库
clinicaltrials.gov
开始日期
2025年1月19日
结束日期
2026年5月31日
最后更新
2个月前
研究类型
Interventional
研究设计
Parallel
性别
All

研究者

责任方
Principal Investigator
主要研究者

Ratcharnon Srifa

Ratcharnon Srifa, Cardiothoracic Resident, MD, Sub-Investigator, Cardiothoracic Division, Department of Surgery

Siriraj Hospital

入排标准

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

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)

研究点 (2)

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