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

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.

Overview

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 :

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.

Interventions

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

Primary outcome measures

• incidence rate of leg swelling [Time frame: 1, 2 and 6 weeks after CABG surgery]
• Rate of severity level of swelling [Time frame: 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]

Secondary outcome measures (3)

• 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]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Thailand · 2 centers

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

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. PMID 6134001
• 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
• O'Hagan B, Kolvekar S. Use of support stockings after cardiac surgery. Prof Nurse. 2000 Jul;15(10):660-2. PMID 12026465

Identifiers

NCT: NCT06603961 · 788/2566(IRB1)

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗