Ignite Creation Date:
2025-12-24 @ 12:21 PM
Ignite Modification Date:
2026-01-07 @ 9:36 AM
Study NCT ID:
NCT06603961
Status:
RECRUITING
Last Update Posted:
2025-04-09
First Post:
2024-09-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prevention of Edema After Coronary Artery Bypass Graft by Customized Pressure-guided Elastic Bandages
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013530', 'term': 'Surgical Wound Infection'}], 'ancestors': [{'id': 'D014946', 'term': 'Wound Infection'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2025-04-01', 'size': 1857295, 'label': 'Study Protocol, Statistical Analysis Plan, and Informed Consent Form', 'hasIcf': True, 'hasSap': True, 'filename': 'Prot_SAP_ICF_002.pdf', 'typeAbbrev': 'Prot_SAP_ICF', 'uploadDate': '2025-04-06T13:04', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 106}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-01-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2026-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-06', 'studyFirstSubmitDate': '2024-09-12', 'studyFirstSubmitQcDate': '2024-09-16', 'lastUpdatePostDateStruct': {'date': '2025-04-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'incidence rate of leg swelling', 'timeFrame': '1, 2 and 6 weeks after CABG surgery', 'description': 'Chi-square test'}, {'measure': 'Rate of severity level of swelling', 'timeFrame': '1, 2 and 6 weeks after CABG surgery', 'description': 'Chi-square test'}, {'measure': 'differences in leg circumference at various locations between preoperative and postoperative measurements between the two groups.', 'timeFrame': '1, 2 and 6 weeks after CABG surgery', 'description': 'Independent sample t-test or Mann-Whitney U test'}], 'secondaryOutcomes': [{'measure': 'infection rate', 'timeFrame': '1, 2 and 6 weeks after CABG surgery', 'description': 'Chi-square test'}, {'measure': 'rate of delayed wound healing', 'timeFrame': '1, 2 and 6 weeks after CABG surgery', 'description': 'Chi-square test'}, {'measure': 'rate of numbness', 'timeFrame': '1, 2 and 6 weeks after CABG surgery', 'description': 'Chi-square test'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['compression bandages', 'compression therapy', 'customized pressure-guided elastic bandages', 'CABG', 'coronary arterial bypass graft'], 'conditions': ['Limb Edema', 'Surgical Site Infections', 'Leg Swelling', 'Compression Bandages', 'Coronary Artery Bypass Graft', 'CABG', 'Saphenectomy', 'Saphenous Vein', 'Delayed Wound Healing', 'Post Operative Complications', 'Post Operative Surgical Site Infection']}, 'referencesModule': {'references': [{'pmid': '6134001', 'type': 'BACKGROUND', 'citation': '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': '2786980', 'type': 'BACKGROUND', 'citation': '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': '10614096', 'type': 'BACKGROUND', 'citation': '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': '27502619', 'type': 'BACKGROUND', 'citation': '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': '1578540', 'type': 'BACKGROUND', 'citation': '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': '32122269', 'type': 'BACKGROUND', 'citation': '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': '10969669', 'type': 'BACKGROUND', 'citation': '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': '12026465', 'type': 'BACKGROUND', 'citation': "O'Hagan B, Kolvekar S. Use of support stockings after cardiac surgery. Prof Nurse. 2000 Jul;15(10):660-2."}, {'pmid': '10571092', 'type': 'BACKGROUND', 'citation': 'Mountney 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.'}, {'pmid': '21944912', 'type': 'BACKGROUND', 'citation': 'Mosti 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.'}, {'pmid': '30626269', 'type': 'BACKGROUND', 'citation': 'Mosti 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.'}, {'pmid': '27036953', 'type': 'BACKGROUND', 'citation': 'Lommerud 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.'}, {'pmid': '1735659', 'type': 'BACKGROUND', 'citation': 'Liehr 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.'}, {'pmid': '19914571', 'type': 'BACKGROUND', 'citation': 'Khoshgoftar 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.'}, {'pmid': '17130317', 'type': 'BACKGROUND', 'citation': 'Ho 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.'}, {'pmid': '29688524', 'type': 'BACKGROUND', 'citation': 'Hassoun-Kheir N, Hasid I, Bozhko M, Shaban Z, Glam R, Hussein K, Paul M. Risk factors for limb surgical site infection following coronary artery bypass graft using open great saphenous vein harvesting: a retrospective cohort study. Interact Cardiovasc Thorac Surg. 2018 Oct 1;27(4):530-535. doi: 10.1093/icvts/ivy137.'}, {'pmid': '29221750', 'type': 'BACKGROUND', 'citation': 'Gulack BC, Kirkwood KA, Shi W, Smith PK, Alexander JH, Burks SG, Gelijns AC, Thourani VH, Bell D, Greenberg A, Goldfarb SD, Mayer ML, Bowdish ME; Cardiothoracic Surgical Trials Network (CTSN). Secondary surgical-site infection after coronary artery bypass grafting: A multi-institutional prospective cohort study. J Thorac Cardiovasc Surg. 2018 Apr;155(4):1555-1562.e1. doi: 10.1016/j.jtcvs.2017.10.078. Epub 2017 Dec 6.'}, {'pmid': '12829071', 'type': 'BACKGROUND', 'citation': 'Garland R, Frizelle FA, Dobbs BR, Singh H. A retrospective audit of long-term lower limb complications following leg vein harvesting for coronary artery bypass grafting. Eur J Cardiothorac Surg. 2003 Jun;23(6):950-5. doi: 10.1016/s1010-7940(03)00116-7.'}, {'pmid': '11789790', 'type': 'BACKGROUND', 'citation': 'Dusterhoft V, Bauer M, Buz S, Schaumann B, Hetzer R. Wound-healing disturbances after vein harvesting for CABG: a randomized trial to compare the minimally invasive direct vision and traditional approaches. Ann Thorac Surg. 2001 Dec;72(6):2038-43. doi: 10.1016/s0003-4975(01)03047-8.'}, {'pmid': '27966395', 'type': 'BACKGROUND', 'citation': 'Andrea Nelson E. Understanding compression therapy. J Wound Care. 1998 Jul 2;7(7):323. doi: 10.12968/jowc.1998.7.7.323.'}, {'pmid': '25478535', 'type': 'BACKGROUND', 'citation': 'Alizadeh-Ghavidel A, Ramezannejad P, Mirmesdagh Y, Sadeghpour-Tabaei A. Prevention of edema after coronary artery bypass graft surgery by compression stockings. Res Cardiovasc Med. 2014 May;3(2):e17463. doi: 10.5812/cardiovascmed.17463. Epub 2014 Apr 1.'}], 'seeAlsoLinks': [{'url': 'https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4253792/', 'label': '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.'}, {'url': 'https://pubmed.ncbi.nlm.nih.gov/19914571/', 'label': '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 study'}, {'url': 'https://pubmed.ncbi.nlm.nih.gov/27502619/', 'label': 'This paper proove that CPG-EB optimal subbandage pressure was not inferior than stockings.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': 'Inclusion Criteria :\n\n1. All patients scheduled for elective coronary artery bypass grafting (CABG) surgery with saphenous vein harvesting from the leg at Siriraj Hospital.\n2. 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.\n\nExclusion Criteria : \\*\n\n1. Patients with an Ankle-brachial pressure index (ABI) \\< 0.8\n2. 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.\n3. Patients with occlusive peripheral arterial disease (PAD) or chronic venous insufficiency (CEAP 2s), characterized by significant venous stasis, leg pain, varicose veins, or lymphadenopathy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. All patients scheduled for elective coronary artery bypass grafting (CABG) surgery with saphenous vein harvesting from the leg at Siriraj Hospital.\n2. 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.\n\nExclusion Criteria:\n\n1. Patients with an Ankle-brachial pressure index (ABI) \\< 0.8\n2. 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.\n3. Patients with occlusive peripheral arterial disease (PAD) or chronic venous insufficiency (CEAP 2s), characterized by significant venous stasis, leg pain, varicose veins, or lymphadenopathy.'}, 'identificationModule': {'nctId': 'NCT06603961', 'acronym': 'PEACCE', 'briefTitle': 'Prevention of Edema After Coronary Artery Bypass Graft by Customized Pressure-guided Elastic Bandages', 'organization': {'class': 'OTHER', 'fullName': 'Siriraj Hospital'}, 'officialTitle': '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.', 'orgStudyIdInfo': {'id': '788/2566(IRB1)'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'CPG-EB group', 'description': 'The intervention group received Customized-pressure guided elastic bandage for 4 weeks post-operatively.', 'interventionNames': ['Device: CPG-EB group']}, {'type': 'NO_INTERVENTION', 'label': 'Standard group', 'description': '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.'}], 'interventions': [{'name': 'CPG-EB group', 'type': 'DEVICE', 'description': 'Customized-pressure guided elastic bandage group', 'armGroupLabels': ['CPG-EB group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10700', 'city': 'Bangkok', 'state': 'Bangkok Noi', 'status': 'NOT_YET_RECRUITING', 'country': 'Thailand', 'contacts': [{'name': 'Ratcharnon Srifa, MD', 'role': 'CONTACT', 'email': 'gainratcharnon@gmail.com', 'phone': '+66819660944'}, {'name': 'Nachasa Khongchu, MSc', 'role': 'CONTACT', 'email': 'nachasa.kho@gmail.com', 'phone': '+66877309986'}, {'name': 'Ratcharnon Srifa, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Prompak Nitayavardhana, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Faculty of Medicine Siriraj Hospital, Mahidol University', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}, {'zip': '10700', 'city': 'Bangkok', 'state': 'Bangkok Noi', 'status': 'RECRUITING', 'country': 'Thailand', 'contacts': [{'name': 'Ratcharnon Srifa, Doctor of medicine', 'role': 'CONTACT', 'phone': '+66819660944'}, {'name': 'Ratcharnon Srifa, Doctor of medicine', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Prompak Nitayavardhana, Diploma of thoracic surgery', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Siriraj hospital', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}], 'centralContacts': [{'name': 'Ratcharnon Srifa, MD', 'role': 'CONTACT', 'email': 'gainratcharnon@gmail.com', 'phone': '+66819660944'}, {'name': 'Nachasa Khongchu, MSc', 'role': 'CONTACT', 'email': 'nachasa.kho@gmail.com', 'phone': '+66877309986'}], 'overallOfficials': [{'name': 'Prompak Nitayavardhana, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Siriraj Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Siriraj Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Ratcharnon Srifa, Cardiothoracic Resident, MD, Sub-Investigator, Cardiothoracic Division, Department of Surgery', 'investigatorFullName': 'Ratcharnon Srifa', 'investigatorAffiliation': 'Siriraj Hospital'}}}}