Prevention of Edema After Coronary Artery Bypass Graft by Customized Pressure-guided Elastic Bandages

Not Applicable

Recruiting

• Conditions: Limb Edema; Surgical Site Infections; Leg Swelling; Compression Bandages; Coronary Artery Bypass Graft; CABG; Saphenectomy; Saphenous Vein; Delayed Wound Healing; Post Operative Complications
• Interventions: Device: CPG-EB group

• Registration Number: NCT06603961
• Lead Sponsor: Siriraj Hospital

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2024-09-12
• Study First Submitted QC: 2024-09-16
• Study First Posted: 2024-09-19
• Study Start: 2025-01-19
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-06
• Last Update Posted: 2025-04-09
• Primary Completion: 2025-12-31
• Study Completion: 2026-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 106

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CPG-EB group	CPG-EB group	Customized-pressure guided elastic bandage group is the interventional group in order to compare with standard of care in post operative CABG surgery patients.

Primary Outcome Measures

Name	Time	Method
incidence rate of leg swelling	1, 2 and 6 weeks after CABG surgery	Chi-square test
Rate of severity level of swelling	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.	1, 2 and 6 weeks after CABG surgery	Independent sample t-test or Mann-Whitney U test

Secondary Outcome Measures

Name	Time	Method
rate of numbness	1, 2 and 6 weeks after CABG surgery	Chi-square test
infection rate	1, 2 and 6 weeks after CABG surgery	Chi-square test
rate of delayed wound healing	1, 2 and 6 weeks after CABG surgery	Chi-square test

Trial Locations

Locations (2)

Siriraj hospital; 🇹🇭 Bangkok, Bangkok Noi, Thailand

Faculty of Medicine Siriraj Hospital, Mahidol University; 🇹🇭 Bangkok, Bangkok Noi, Thailand