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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSiriraj Hospital

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • CPG-EB group

    Device

    Customized-pressure guided elastic bandage group

Treatment groups

106 Participants
are divided into 2 treatment groups
Group A: CPG-EB groupActive comparator 1 intervention
Group B: Standard groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

incidence rate of leg swelling

Chi-square test

Time frame
1, 2 and 6 weeks after CABG surgery
2

Rate of severity level of swelling

Chi-square test

Time frame
1, 2 and 6 weeks after CABG surgery
3

differences in leg circumference at various locations between preoperative and postoperative measurements between the two groups.

Independent sample t-test or Mann-Whitney U test

Time frame
1, 2 and 6 weeks after CABG surgery

Secondary outcomes

1

infection rate

Chi-square test

Time frame
1, 2 and 6 weeks after CABG surgery
2

rate of delayed wound healing

Chi-square test

Time frame
1, 2 and 6 weeks after CABG surgery
3

rate of numbness

Chi-square test

Time frame
1, 2 and 6 weeks after CABG surgery

Other outcomes

Sponsors and contacts

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