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

NCT06603961 | Recruiting

• 1 other identifier: 788/2566(IRB1)
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Keywords

compression bandages; compression therapy; customized pressure-guided elastic bandages; CABG; coronary arterial bypass graft

Outcome Measures

Primary Outcomes (3)

• incidence rate of leg swelling

  Chi-square test

  1, 2 and 6 weeks after CABG surgery

• Rate of severity level of swelling

  Chi-square test

  1, 2 and 6 weeks after CABG surgery

• 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

  1, 2 and 6 weeks after CABG surgery

Secondary Outcomes (3)

• infection rate

  1, 2 and 6 weeks after CABG surgery

• rate of delayed wound healing

  1, 2 and 6 weeks after CABG surgery

• rate of numbness

  1, 2 and 6 weeks after CABG surgery

Study Arms (2)

CPG-EB group

ACTIVE COMPARATOR

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

Device: CPG-EB group

Standard group

NO INTERVENTION

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.

Interventions

CPG-EB group DEVICE

Customized-pressure guided elastic bandage group

CPG-EB group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Siriraj Hospital: lead

Study Sites (2)

Faculty of Medicine Siriraj Hospital, Mahidol University

Bangkok, Bangkok Noi, 10700, Thailand

NOT YET RECRUITING

Siriraj hospital

Bangkok, Bangkok Noi, 10700, Thailand

RECRUITING

Related Publications (21)

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  PMID: 27502619 BACKGROUND

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  PMID: 21944912 BACKGROUND

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  PMID: 30626269 BACKGROUND

• Lommerud S, Hofoss D. Leg wound infection after coronary artery bypass grafting: A natural experiment comparing use and non-use of a compression stocking. Eur J Cardiovasc Nurs. 2017 Feb;16(2):136-142. doi: 10.1177/1474515116641298. Epub 2016 Jul 8.

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  PMID: 1735659 BACKGROUND

• Khoshgoftar Z, Ayat Esfahani F, Marzban M, Salehi Omran A, Haji Ghasemi A, Movaghar S, Saadat S. Comparison of compression stocking with elastic bandage in reducing postoperative edema in coronary artery bypass graft patient. J Vasc Nurs. 2009 Dec;27(4):103-6. doi: 10.1016/j.jvn.2009.09.004.

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  PMID: 29688524 BACKGROUND

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• Garland R, Frizelle FA, Dobbs BR, Singh H. A retrospective audit of long-term lower limb complications following leg vein harvesting for coronary artery bypass grafting. Eur J Cardiothorac Surg. 2003 Jun;23(6):950-5. doi: 10.1016/s1010-7940(03)00116-7.

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• Dusterhoft V, Bauer M, Buz S, Schaumann B, Hetzer R. Wound-healing disturbances after vein harvesting for CABG: a randomized trial to compare the minimally invasive direct vision and traditional approaches. Ann Thorac Surg. 2001 Dec;72(6):2038-43. doi: 10.1016/s0003-4975(01)03047-8.

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Related Links

• This study use the TED stockings after CABG and the protocol. such as the severity of edema and timing of follow up, from this study was used in my study.
• This study compare between stockings and conventional elastic bandages. The protocol, such as difference of circumference between preoperative leg and postoperative leg, was used in my study
• This paper proove that CPG-EB optimal subbandage pressure was not inferior than stockings.

MeSH Terms

Conditions

Surgical Wound Infection

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Prompak Nitayavardhana, MD

  Siriraj Hospital

  STUDY DIRECTOR

Central Study Contacts

Ratcharnon Srifa, MD

CONTACT

+66819660944; gainratcharnon@gmail.com

Nachasa Khongchu, MSc

CONTACT

+66877309986; nachasa.kho@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ratcharnon Srifa, Cardiothoracic Resident, MD, Sub-Investigator, Cardiothoracic Division, Department of Surgery

Study Record Dates

• First Submitted: September 12, 2024
• First Posted: September 19, 2024
• Study Start: January 19, 2025
• Primary Completion: March 31, 2026
• Study Completion (Estimated): May 31, 2026
• Last Updated: February 9, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

TH (2)