NCT06603961 Prevention of Edema After Coronary Artery Bypass Graft by Customized Pressure-guided Elastic Bandages
| NCT ID | NCT06603961 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Siriraj Hospital |
| Condition | Limb Edema |
| Study Type | INTERVENTIONAL |
| Enrollment | 106 participants |
| Start Date | 2025-01-19 |
| Primary Completion | 2026-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 106 participants in total. It began in 2025-01-19 with a primary completion date of 2026-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Prompak Nitayavardhana, MD
STUDY DIRECTOR
Siriraj Hospital
Frequently Asked Questions
Who can join the NCT06603961 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Limb Edema. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06603961 currently recruiting?
Yes, NCT06603961 is actively recruiting participants. Contact the research team at gainratcharnon@gmail.com for enrollment information.
Where is the NCT06603961 trial being conducted?
This trial is being conducted at Bangkok, Thailand, Bangkok, Thailand.
Who is sponsoring the NCT06603961 clinical trial?
NCT06603961 is sponsored by Siriraj Hospital. The principal investigator is Prompak Nitayavardhana, MD at Siriraj Hospital. The trial plans to enroll 106 participants.