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

Siriraj Hospital

Status: Enrolling

Conditions: Coronary Artery Bypass Graft; Post Operative Complications; CABG; Limb Edema; Leg Swelling; Saphenectomy; Saphenous Vein; Delayed Wound Healing; Surgical Site Infections; Post Operative Surgical Site Infection; Compression Bandages

Treatments: Device: CPG-EB group

Study type: Interventional

Funder types: Other

Identifiers

NCT06603961

788/2566(IRB1)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 106 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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106 participants in 2 patient groups

CPG-EB group

Active Comparator group

Description:

The intervention group received Customized-pressure guided elastic bandage for 4 weeks post-operatively.

Treatment:

Device: CPG-EB group

Standard group

No Intervention group

Description:

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.