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
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