Limb EdemaPEACCENCT06603961
Prevention of Edema After Coronary Artery Bypass Graft by Customized Pressure-guided Elastic Bandages
A study testing CPG-EB group in people with Limb Edema and Surgical Site Infections, run by Siriraj Hospital at 2 sites in Thailand.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Limb Edema, Surgical Site Infections, Leg Swelling
- What is being tested?
- CPG-EB group
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 2 sitesThailand
- Study dates
- 19 Jan 2025to 31 May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Thailand2 sites, 2 recruiting
- Not yet recruiting
Faculty of Medicine Siriraj Hospital, Mahidol University
Bangkok, Bangkok Noi, 10700
Ratcharnon Srifa, MD, +66819660944, gainratcharnon@gmail.com
Nachasa Khongchu, MSc, +66877309986, nachasa.kho@gmail.com
- Recruiting
Siriraj hospital
Bangkok, Bangkok Noi, 10700
Ratcharnon Srifa, Doctor of medicine, +66819660944
Ratcharnon Srifa, Doctor of medicine
About this study
Official 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.
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.
Read the detailed description
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.
- Conditions
- Limb Edema, Surgical Site Infections, Leg Swelling, Compression Bandages, Coronary Artery Bypass Graft, CABG
- Being tested
- CPG-EB group
- Keywords
- compression bandages, compression therapy, customized pressure-guided elastic bandages, CABG, coronary arterial bypass graft
- Medical subject headings
- Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPG-EB groupDevice
Customized-pressure guided elastic bandage group
| Study group | Role | What they receive |
|---|---|---|
| CPG-EB group | Active comparator | The intervention group received Customized-pressure guided elastic bandage for 4 weeks post-operatively. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence rate of leg swelling
Chi-square test
Measured: 1, 2 and 6 weeks after CABG surgery
Rate of severity level of swelling
Chi-square test
Measured: 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
Measured: 1, 2 and 6 weeks after CABG surgery
Secondary outcomes (3)
infection rate
Chi-square test
Measured: 1, 2 and 6 weeks after CABG surgery
rate of delayed wound healing
Chi-square test
Measured: 1, 2 and 6 weeks after CABG surgery
rate of numbness
Chi-square test
Measured: 1, 2 and 6 weeks after CABG surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start19 Jan 2025
- Primary completion31 Mar 2026 (estimated)
- Study completion31 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for Limb EdemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 106 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Siriraj Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ratcharnon Srifa, Siriraj Hospital
- Investigators
- Prompak Nitayavardhana, MD, Study director, Siriraj Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06603961
- Sponsor's protocol ID
- 788/2566(IRB1)
- Acronym
- PEACCE
- Status last verified
- Feb 2026
- First submitted
- 12 Sep 2024
- Last updated
- 9 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wells FC, Newsom SW, Rowlands C. Wound infection in cardiothoracic surgery. Lancet. 1983 May 28;1(8335):1209-10. doi: 10.1016/s0140-6736(83)92479-0.
PubMed 6134001Utley JR, Thomason ME, Wallace DJ, Mutch DW, Staton L, Brown V, Wilde CM, Bell MS. Preoperative correlates of impaired wound healing after saphenous vein excision. J Thorac Cardiovasc Surg. 1989 Jul;98(1):147-9.
PubMed 2786980Terada Y, Fukuda S, Tohda E, Kigawa I, Wanibuchi Y, Mitsui T. Venous function and delayed leg swelling following saphenectomy in coronary artery bypass grafting. Jpn J Thorac Cardiovasc Surg. 1999 Nov;47(11):559-62. doi: 10.1007/BF03218062.
PubMed 10614096Sermsathanasawadi N, Chatjaturapat C, Pianchareonsin R, Puangpunngam N, Wongwanit C, Chinsakchai K, Ruangsetakit C, Mutirangura P. Use of customised pressure-guided elastic bandages to improve efficacy of compression bandaging for venous ulcers. Int Wound J. 2017 Aug;14(4):636-640. doi: 10.1111/iwj.12656. Epub 2016 Aug 9.
PubMed 27502619Reifsnyder T, Bandyk D, Seabrook G, Kinney E, Towne JB. Wound complications of the in situ saphenous vein bypass technique. J Vasc Surg. 1992 May;15(5):843-8; discussion 848-50. doi: 10.1067/mva.1992.36658.
PubMed 1578540Rabe E, Partsch H, Morrison N, Meissner MH, Mosti G, Lattimer CR, Carpentier PH, Gaillard S, Junger M, Urbanek T, Hafner J, Patel M, Wu S, Caprini J, Lurie F, Hirsch T. Risks and contraindications of medical compression treatment - A critical reappraisal. An international consensus statement. Phlebology. 2020 Aug;35(7):447-460. doi: 10.1177/0268355520909066. Epub 2020 Mar 2.
PubMed 32122269Paletta CE, Huang DB, Fiore AC, Swartz MT, Rilloraza FL, Gardner JE. Major leg wound complications after saphenous vein harvest for coronary revascularization. Ann Thorac Surg. 2000 Aug;70(2):492-7. doi: 10.1016/s0003-4975(00)01414-4.
PubMed 10969669O'Hagan B, Kolvekar S. Use of support stockings after cardiac surgery. Prof Nurse. 2000 Jul;15(10):660-2.
PubMed 12026465Mountney J, Wilkinson GA. Saphenous neuralgia after coronary artery bypass grafting. Eur J Cardiothorac Surg. 1999 Oct;16(4):440-3. doi: 10.1016/s1010-7940(99)00294-8.
PubMed 10571092Mosti G, Iabichella ML, Partsch H. Compression therapy in mixed ulcers increases venous output and arterial perfusion. J Vasc Surg. 2012 Jan;55(1):122-8. doi: 10.1016/j.jvs.2011.07.071. Epub 2011 Sep 23.
PubMed 21944912Mosti G, Cavezzi A. Compression therapy in lymphedema: Between past and recent scientific data. Phlebology. 2019 Sep;34(8):515-522. doi: 10.1177/0268355518824524. Epub 2019 Jan 9. No abstract available.
PubMed 30626269Lommerud 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.
PubMed 27036953Liehr P, Todd B, Rossi M, Culligan M. Effect of venous support on edema and leg pain in patients after coronary artery bypass graft surgery. Heart Lung. 1992 Jan;21(1):6-11.
PubMed 1735659Khoshgoftar 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.
PubMed 19914571Ho CK, Sun MP, Au TW, Chiu CS. Pneumatic pump reduces leg wound complications in cardiac patients. Asian Cardiovasc Thorac Ann. 2006 Dec;14(6):452-7. doi: 10.1177/021849230601400602.
PubMed 17130317
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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.
- ClinicalTrials.gov ID
- NCT06603961
- Acronym / sponsor ID
- PEACCE / 788/2566(IRB1)
- Conditions
- Limb Edema, Surgical Site Infections, Leg Swelling, Compression Bandages, Coronary Artery Bypass Graft, CABG
- Keywords
- compression bandages, compression therapy, customized pressure-guided elastic bandages, CABG, coronary arterial bypass graft
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 106 participants (estimated)
- Lead sponsor
- Siriraj HospitalUniversity, hospital or other
- Study start
- 19 Jan 2025 (actual)
- Primary completion
- 31 Mar 2026 (estimated)
- Study completion
- 31 May 2026 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CPG-EB group | Active comparator | Device: CPG-EB groupThe intervention group received Customized-pressure guided elastic bandage for 4 weeks post-operatively. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CPG-EB groupCustomized-pressure guided elastic bandage group | Device | CPG-EB group |
Primary outcome
incidence rate of leg swelling
Time frame: 1, 2 and 6 weeks after CABG surgery
Chi-square test
Rate of severity level of swelling
Time frame: 1, 2 and 6 weeks after CABG surgery
Chi-square test
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
3 secondary outcomes
infection rate
Time frame: 1, 2 and 6 weeks after CABG surgery
rate of delayed wound healing
Time frame: 1, 2 and 6 weeks after CABG surgery
rate of numbness
Time frame: 1, 2 and 6 weeks after CABG surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2026.
- Background: PubMed 6134001Wells FC, Newsom SW, Rowlands C. Wound infection in cardiothoracic surgery. Lancet. 1983 May 28;1(8335):1209-10. doi: 10.1016/s0140-6736(83)92479-0.
- Background: PubMed 2786980Utley JR, Thomason ME, Wallace DJ, Mutch DW, Staton L, Brown V, Wilde CM, Bell MS. Preoperative correlates of impaired wound healing after saphenous vein excision. J Thorac Cardiovasc Surg. 1989 Jul;98(1):147-9.
- Background: PubMed 10614096Terada Y, Fukuda S, Tohda E, Kigawa I, Wanibuchi Y, Mitsui T. Venous function and delayed leg swelling following saphenectomy in coronary artery bypass grafting. Jpn J Thorac Cardiovasc Surg. 1999 Nov;47(11):559-62. doi: 10.1007/BF03218062.
- Background: PubMed 27502619Sermsathanasawadi N, Chatjaturapat C, Pianchareonsin R, Puangpunngam N, Wongwanit C, Chinsakchai K, Ruangsetakit C, Mutirangura P. Use of customised pressure-guided elastic bandages to improve efficacy of compression bandaging for venous ulcers. Int Wound J. 2017 Aug;14(4):636-640. doi: 10.1111/iwj.12656. Epub 2016 Aug 9.
- Background: PubMed 1578540Reifsnyder T, Bandyk D, Seabrook G, Kinney E, Towne JB. Wound complications of the in situ saphenous vein bypass technique. J Vasc Surg. 1992 May;15(5):843-8; discussion 848-50. doi: 10.1067/mva.1992.36658.
- Background: PubMed 32122269Rabe E, Partsch H, Morrison N, Meissner MH, Mosti G, Lattimer CR, Carpentier PH, Gaillard S, Junger M, Urbanek T, Hafner J, Patel M, Wu S, Caprini J, Lurie F, Hirsch T. Risks and contraindications of medical compression treatment - A critical reappraisal. An international consensus statement. Phlebology. 2020 Aug;35(7):447-460. doi: 10.1177/0268355520909066. Epub 2020 Mar 2.
- Background: PubMed 10969669Paletta CE, Huang DB, Fiore AC, Swartz MT, Rilloraza FL, Gardner JE. Major leg wound complications after saphenous vein harvest for coronary revascularization. Ann Thorac Surg. 2000 Aug;70(2):492-7. doi: 10.1016/s0003-4975(00)01414-4.
- Background: PubMed 12026465O'Hagan B, Kolvekar S. Use of support stockings after cardiac surgery. Prof Nurse. 2000 Jul;15(10):660-2.
- Background: PubMed 10571092Mountney J, Wilkinson GA. Saphenous neuralgia after coronary artery bypass grafting. Eur J Cardiothorac Surg. 1999 Oct;16(4):440-3. doi: 10.1016/s1010-7940(99)00294-8.
- Background: PubMed 21944912Mosti G, Iabichella ML, Partsch H. Compression therapy in mixed ulcers increases venous output and arterial perfusion. J Vasc Surg. 2012 Jan;55(1):122-8. doi: 10.1016/j.jvs.2011.07.071. Epub 2011 Sep 23.
- Background: PubMed 30626269Mosti G, Cavezzi A. Compression therapy in lymphedema: Between past and recent scientific data. Phlebology. 2019 Sep;34(8):515-522. doi: 10.1177/0268355518824524. Epub 2019 Jan 9. No abstract available.
- Background: PubMed 27036953Lommerud 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.
- 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.Link provided by the sponsor.
- 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 studyLink provided by the sponsor.
- This paper proove that CPG-EB optimal subbandage pressure was not inferior than stockings.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Prompak Nitayavardhana, MD study director
Siriraj Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CPG-EB group in people with Limb Edema and Surgical Site Infections, run by Siriraj Hospital at 2 sites in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ratcharnon Srifa, MD (+66819660944, gainratcharnon@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence rate of leg swelling (time frame: 1, 2 and 6 weeks after CABG surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06603961, which also lists 21 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2026.