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NCT Number: NCT06603961

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

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.

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Key information

Conditions

Limb Edema CABG Compression Bandages Coronary Artery Bypass Graft Delayed Wound Healing Infections Leg Swelling Pathologic Processes Pathological Conditions, Signs and Symptoms Post Operative Complications Post Operative Surgical Site Infection Postoperative Complications Saphenectomy Saphenous Vein Surgical Site Infections Surgical Wound Infection Wound Infection

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Bangkok Noi, Thailand

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About this study

Inclusion criteria

  • 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.

Exclusion criteria

*

  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

CPG-EB group

Device

Customized-pressure guided elastic bandage group

Primary outcomes

  1. incidence rate of leg swelling

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

    Chi-square test

  2. Rate of severity level of swelling

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

    Chi-square test

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

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

    Independent sample t-test or Mann-Whitney U test

Secondary outcomes

  1. infection rate

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

    Chi-square test

  2. rate of delayed wound healing

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

    Chi-square test

  3. rate of numbness

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

    Chi-square test

Study contacts

Contact information is provided by the study sponsor or research team.

Nachasa Khongchu, MSc

CONTACT

[email protected]

+66877309986

Ratcharnon Srifa, MD

CONTACT

[email protected]

+66819660944

Sponsors and collaborators

Lead sponsor

Siriraj Hospital

Other

Registry information

Official study title

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.

Acronym: PEACCE

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 19, 2024
Registry last updated
Feb 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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