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

Last updated: April 6, 2025
Sponsor: Siriraj Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

CPG-EB group

Clinical Study ID

NCT06603961
788/2566(IRB1)
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. All patients scheduled for elective coronary artery bypass grafting (CABG) surgerywith saphenous vein harvesting from the leg at Siriraj Hospital.

  2. Patients aged 18 years and older undergoing CABG surgery with saphenous veinharvesting from the leg at Siriraj Hospital, who willingly consent to participate inthe study.

Exclusion

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 withpre-existing or post-operative heart failure that remains uncontrolled despitediuretic therapy.

  3. Patients with occlusive peripheral arterial disease (PAD) or chronic venousinsufficiency (CEAP 2s), characterized by significant venous stasis, leg pain,varicose veins, or lymphadenopathy.

Study Design

Total Participants: 106
Treatment Group(s): 1
Primary Treatment: CPG-EB group
Phase:
Study Start date:
January 19, 2025
Estimated Completion Date:
March 31, 2026

Study 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.

Connect with a study center

  • Faculty of Medicine Siriraj Hospital, Mahidol University

    Bangkok, Bangkok Noi 10700
    Thailand

    Site Not Available

  • Siriraj hospital

    Bangkok, Bangkok Noi 10700
    Thailand

    Active - Recruiting

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