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

February 6, 2026 updated by: Ratcharnon Srifa, Siriraj Hospital

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.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

106

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Thailand
    • Bangkok Noi
      • Bangkok, Bangkok Noi, Thailand, 10700
        • Recruiting
        • Siriraj Hospital
        • Contact:
          • Ratcharnon Srifa, Doctor of medicine
          • Phone Number: +66819660944
        • Sub-Investigator:
          • Ratcharnon Srifa, Doctor of medicine
        • Principal Investigator:
          • Prompak Nitayavardhana, Diploma of thoracic surgery
      • Bangkok, Bangkok Noi, Thailand, 10700
        • Not yet recruiting
        • Faculty of Medicine Siriraj Hospital, Mahidol University
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Ratcharnon Srifa, MD
        • Principal Investigator:
          • Prompak Nitayavardhana, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Standard group
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.
Active Comparator: CPG-EB group
The intervention group received Customized-pressure guided elastic bandage for 4 weeks post-operatively.
Device: CPG-EB group
Customized-pressure guided elastic bandage group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
incidence rate of leg swelling
Time Frame: 1, 2 and 6 weeks after CABG surgery
Chi-square test
1, 2 and 6 weeks after CABG surgery
Rate of severity level of swelling
Time Frame: 1, 2 and 6 weeks after CABG surgery
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.
Time Frame: 1, 2 and 6 weeks after CABG surgery
Independent sample t-test or Mann-Whitney U test
1, 2 and 6 weeks after CABG surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
infection rate
Time Frame: 1, 2 and 6 weeks after CABG surgery
Chi-square test
1, 2 and 6 weeks after CABG surgery
rate of delayed wound healing
Time Frame: 1, 2 and 6 weeks after CABG surgery
Chi-square test
1, 2 and 6 weeks after CABG surgery
rate of numbness
Time Frame: 1, 2 and 6 weeks after CABG surgery
Chi-square test
1, 2 and 6 weeks after CABG surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Siriraj Hospital

Investigators

  • Study Director: Prompak Nitayavardhana, MD, Siriraj Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 19, 2025

Primary Completion (Estimated)

March 31, 2026

Study Completion (Estimated)

May 31, 2026

Study Registration Dates

First Submitted

September 12, 2024

First Submitted That Met QC Criteria

September 16, 2024

First Posted (Actual)

September 19, 2024

Study Record Updates

Last Update Posted (Actual)

February 9, 2026

Last Update Submitted That Met QC Criteria

February 6, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 788/2566(IRB1)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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