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

Официальное название

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.

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство CPG-EB group
  Customized-pressure guided elastic bandage group

Первичные конечные точки

• incidence rate of leg swelling [Срок оценки: 1, 2 and 6 weeks after CABG surgery]
• Rate of severity level of swelling [Срок оценки: 1, 2 and 6 weeks after CABG surgery]
• differences in leg circumference at various locations between preoperative and postoperative measurements between the two groups. [Срок оценки: 1, 2 and 6 weeks after CABG surgery]

Вторичные конечные точки (3)

• infection rate [Срок оценки: 1, 2 and 6 weeks after CABG surgery]
• rate of delayed wound healing [Срок оценки: 1, 2 and 6 weeks after CABG surgery]
• rate of numbness [Срок оценки: 1, 2 and 6 weeks after CABG surgery]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Таиланд · 2 центра

• Faculty of Medicine Siriraj Hospital, Mahidol University — Bangkok
• Siriraj hospital — Bangkok

Публикации

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• Utley 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. PMID 2786980
• Terada 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. PMID 10614096
• Sermsathanasawadi 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. PMID 27502619
• Reifsnyder 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. PMID 1578540
• Rabe 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. PMID 32122269
• Paletta 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. PMID 10969669
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Идентификаторы

NCT: NCT06603961 · 788/2566(IRB1)

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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