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.
Phase: NA
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
Sponsor: Siriraj Hospital

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Study Protocol and 
Statistical Analysis 
Plan 
PREVENTION OF EDEMA AFTER CORONARY 
ARTERY BYPASS GRAFT BY CUSTOMIZED 
PRESSURE-GUIDED ELASTIC BANDAGES (PEACCE) 
788/2566(IRB1) 
• PROMPAK NITAYAVARDHANA, STAFF, MD, GRAD 
DIP CLIN SC (SURG), DIP THAI BRD THORAC SURG, 
FRCST, PRINCIPAL INVESTIGATOR 
• RATCHARNON SRIFA, CARDIOTHORACIC RESIDENT, 
MD, SUB-INVESTIGATOR     

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Study Protocol and Sta.s.cal Analysis Plan 
Sample size calcula.on  
 
Previous research reported a 98% incidence of leg edema at two weeks in pa<ents who 
inconsistently wore compression stockings.(1) In this study, the use of high-pressure elas<c bandages 
is hypothesized to reduce the incidence of edema by 20%. The study is designed with a Type I error 
rate of 0.05 and a Type II error rate of 0.2. The incidence of leg edema in pa<ents who inconsistently 
wear compression stockings is 0.98, and the expected incidence with the use of high-pressure elas<c 
bandages is 0.8. The sample size was calculated to be 47 par<cipants per group, with an addi<onal 
10% dropout rate. Therefore, the study will require 53 par<cipants per group. 
 
Inclusion Criteria: 
All pa<ents undergoing elec<ve coronary artery bypass graO (CABG) surgery with saphenous vein 
harves<ng at Siriraj Hospital. 
Pa<ents aged 18 years or older who undergo CABG using saphenous vein graOs at Siriraj Hospital and 
voluntarily consent to par<cipate in the study. 
Exclusion Criteria: 
Pa<ents with an ankle-brachial pressure index (ABI) < 0.8. 
Pa<ents with severe leg edema (piWng edema grade 3+ or higher) or uncontrolled heart failure, pre- 
or post-CABG, despite the use of diure<cs. 
Pa<ents with deep vein thrombosis (DVT) or chronic venous insuﬃciency (e.g., varicose veins with 
pain, CEAP 2s), or those with lympha<c disorders in the leg (lymphadenopathy). 
 
Withdrawal or Termina.on Criteria: 
Pa<ents who develop postopera<ve complica<ons from saphenous vein harves<ng, such as wound 
dehiscence or infec<on, will be withdrawn from the study as they require appropriate treatment that 
may aﬀect the primary outcomes. 
Subject Alloca.on: 

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Par<cipants will be divided into two groups: 
1. Group receiving customized pressure-guided elas<c bandages (CPG-EB) for 4 weeks aOer 
CABG surgery. 
2. Group receiving standard post-CABG care. 
The alloca<on will be done using simple randomiza<on, ensuring equal numbers in each group. 
Research Procedure: 
1. Recruitment: Par<cipants will be selected based on inclusion and exclusion criteria. All 
coronary artery bypass graO (CABG) candidates will undergo ankle-brachial index (ABI) 
measurements. 
2. Consent: Eligible par<cipants will receive detailed explana<ons of the study and sign 
informed consent documents. 
3. Baseline Measurements: Leg circumference will be measured at key loca<ons (mid-arch, 
above the ankle, calf, thigh) before the surgery to establish a baseline. 
4. Randomiza.on: Par<cipants will be randomly assigned to one of the two treatment groups 
using sealed envelopes. Both par<cipants and inves<gators will be blinded to group 
assignment. 
5. CPG-EB Group: Par<cipants in this group will be trained on using CPG-EB by clinical staﬀ. The 
bandage will be applied star<ng at the foot, following speciﬁc instruc<ons for achieving the 
correct pressure gradient. 
6. Surgery and Postopera.ve Care: All pa<ents will undergo saphenous vein harves<ng using 
the conven<onal open technique. AOer surgery, an elas<c bandage will be applied to control 
ini<al bleeding and swelling. 
7. Post-Surgery Wound Care: AOer 24 hours, wounds will be dressed, and elas<c bandages will 
be replaced with either CPG-EB or standard dressings, depending on group alloca<on. CPG-
EB par<cipants will be trained again on proper applica<on before discharge. 
8. Follow-Up Assessments: Leg circumference and edema severity (graded from 0 to +4) will be 
evaluated at 1-, 2-, and 6-weeks post-surgery. Wound healing and complica<ons, including 
infec<ons, will be recorded. 
9. Standard Care Group: Par<cipants will receive standard wound care instruc<ons, without the 
use of CPG-EB. 
10. Outcome Measurements: Edema will be assessed by examining the medial malleolus, <bia, 
and dorsum of the foot. Complica<ons like wound non-union or infec<on will be recorded at 
regular intervals. 
All data will be collected in the outpa<ent clinic at scheduled follow-ups 1-, 2-, and 6-weeks post-
surgery. 
Study Dura.on: 

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The total study dura<on spans from hospital admission for surgery un<l 6 weeks post-surgery. 
Outcome measurements will be conducted at 1, 2, and 6 weeks aOer surgery, with some par<cipants 
discharged from the hospital during this period. 
Data Collec.on: 
All data recorded in case report forms (CRFs) must not include iden<ﬁable personal informa<on, such 
as names, hospital numbers (HN), or any other iden<fying details. Par<cipants will be assigned codes 
for data anonymiza<on. The CRF will include the following informa<on: 
1. Date of study enrollment. 
2. Demographic informa<on: age, sex, weight, height, and BMI. 
3. Comorbidi<es. 
4. New York Heart Associa<on (NYHA) classiﬁca<on. 
5. Coronary artery disease characteris<cs: a. LVEF % b. Cardiac arrhythmia c. Valvular heart 
disease d. Aor<c disease 
6. Preopera<ve laboratory results: a. Hemoglobin (Hb) and hematocrit (Hct) b. Blood urea 
nitrogen (BUN), crea<nine (Cr) c. Total protein d. Albumin 
7. Circumferen<al measurements of both legs. 
8. Pulse examina<on at the posterior <bial and dorsalis pedis arteries. 
9. Ankle-brachial index (ABI) for both legs. 
10. Leg edema severity, evaluated at the medial malleolus, <bia, and dorsum of the foot using 
the following scale: 
• 
0: No edema 
• 
+1: Barely detectable 
• 
+2: Slight indenta<on, 15 seconds rebound 
• 
+3: Deeper indenta<on, 30 seconds rebound 
• 
+4: > 30 seconds rebound 

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11. Postopera<ve complica<ons: a. Surgical site infec<on (SSI) b. Delayed wound healing c. 
Tingling or numbness 
Deﬁni.ons of Postopera.ve Complica.ons: 
1. Surgical Site Infec.on (SSI): An infec<on occurring within 65 days post-surgery, with at least 
one of the following symptoms: a. Purulent drainage from the incision. b. Wound dehiscence 
or opening due to fever, localized pain, or a posi<ve culture (if no culture or a nega<ve result, 
both fever and localized pain are required). c. Evidence of infec<on through clinical 
examina<on or imaging (e.g., ultrasound or CT scan). d. Diagnosis of SSI by a physician. 
2. Delayed Wound Healing: Deﬁned as the wound not healing by 2 weeks post-surgery. 
Outcome Measurement and Data Analysis: 
• 
Primary Outcomes: 
o 
Incidence of leg edema: Compared between the two groups using the Chi-square 
test. 
o 
Edema severity: Compared between groups using the Chi-square test. 
o 
Leg circumferen.al diﬀerences: Measured before and aOer surgery and compared 
between groups using the independent sample t-test or Mann-Whitney U test. 
• 
Secondary Outcomes: 

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o 
Infec.on rates: Compared between groups using the Chi-square test. 
o 
Delayed wound healing rates: Compared between groups using the Chi-square test. 
o 
Incidence of postopera.ve leg numbness: Compared between groups using the Chi-
square test. 
 
Reference 
1. 
Alizadeh-Ghavidel A, Ramezannejad P, Mirmesdagh Y, Sadeghpour-Tabaei A. Preven<on of 
edema aOer coronary artery bypass graO surgery by compression stockings. Res Cardiovasc Med. 
2014;3(2):e17463. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Participant 
Information 
Sheet/Consent Form 
PREVENTION OF EDEMA AFTER CORONARY ARTERY 
BYPASS GRAFT BY CUSTOMIZED PRESSURE-GUIDED 
ELASTIC BANDAGES (PEACCE) 788/2566(IRB1) 
• PROMPAK NITAYAVARDHANA, STAFF, MD, GRAD DIP CLIN 
SC (SURG), DIP THAI BRD THORAC SURG, FRCST, PRINCIPAL 
INVESTIGATOR 
• RATCHARNON SRIFA, CARDIOTHORACIC RESIDENT, MD, 
SUB-INVESTIGATOR     

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Participant Information Sheet/Consent Form 
For Parents/Legal Guardians 
This document provides important information regarding the research study in 
which your child or ward is invited to participate. Please take your time to carefully read 
through this information, and feel free to ask any questions you may have before making a 
decision. You are encouraged to discuss this document with your family, close friends, or 
your child’s/ward’s physician to help with your decision. You may also take this document 
home for further review before deciding to participate. 
 
Research Study Title: Prevention of Post-Coronary Artery Bypass Graft (CABG) Leg Swelling 
Using Pressure-Guided Compression Bandages 
 
Principal Investigator: 
Dr. Prompak Nitayavardhana, M.D. 
 
Research Locations: 
Cardiothoracic Surgery Outpatient Clinic 
Wound Care Room 101, Syamindra Building 
Pre- and Post-Operative Ward 
Cardiothoracic Operating Room, Siriraj Hospital 
 
Workplace and Contact Information for Principal Investigator: 
Cardiothoracic Surgery Division, Syamindra Building, 12th Floor, Department of Surgery, Faculty 
of Medicine, Siriraj Hospital 
Phone: 02-419-7998, 02-419-9003, +6685-914-1236, +6681-966-0944 

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Conﬂicts of Interest with Funding Sources: 
☑ None 
☐ Yes, specify: .................................................................................... 
 
Duration of the Study: 2 years 
Background of the Study: 
Coronary artery bypass graft (CABG) surgery is widely performed as a treatment for 
coronary artery disease. The saphenous vein in the leg is frequently used for grafting due to 
its size and length, making it ideal for multiple coronary bypasses. However, complications 
may arise from harvesting the saphenous vein, including swelling, infection, and delayed 
wound healing. These complications can cause pain or numbness in the leg, potentially 
reducing mobility and delaying recovery after surgery. 
 
Compression therapy, which increases external pressure on the leg, has been shown 
to reduce swelling in patients with chronic venous insufﬁciency and lymphedema. By 
reducing blood pooling in the lower veins and improving lymphatic drainage, compression 
can help reduce swelling and support post-operative recovery. 
 
In this study, we aim to evaluate whether the use of customized pressure-guided 
elastic bandages (CPG-EB) can help reduce the risk of leg swelling and other post-operative 
complications in patients who have undergone CABG surgery using the saphenous vein. 
 
Study Objective: 
This study seeks to determine whether compression therapy using customized 
pressure-guided elastic bandages (CPG-EB) can prevent post-surgical complications, 

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particularly leg swelling, in patients who have undergone CABG surgery using the saphenous 
vein. 
 
Participants: 
Patients invited to participate in this study must meet the following criteria: 
1. Be 18 years of age or older. 
2. Have coronary artery disease requiring CABG using the saphenous vein from the leg. 
A total of approximately 106 participants will be enrolled in this study. 
 
Study Procedures: 
Currently, standard post-operative care for saphenous vein harvesting involves 
applying elastic bandages to the leg for 24 hours post-surgery to control bleeding. The 
bandages are then removed for wound care, and no further compression is typically applied. 
However, some patients experience complications following saphenous vein 
harvesting, such as leg swelling, which is the most common, wound infections, delayed 
wound healing, and pain or numbness in the leg. These complications may reduce mobility 
and delay post-operative recovery. 
In this study, patients scheduled for CABG will be screened to ensure they do not 
have pre-existing conditions such as heart failure or chronic leg swelling that would exclude 
them from the study. Eligible participants will have their Ankle-Brachial Pressure Index (ABI) 
measured to ensure there are no contraindications to high compression therapy, with a cutoff 
of ABI ≥0.8. If eligible, the patient will be asked to provide informed consent to participate in 
the study. 
 
Participants will be randomly assigned to one of two groups: 
1. The standard post-CABG care group. 
2. The CPG-EB group, patients will be treated with customized pressure-guided elastic 
bandages (CPG-EB) for 4 weeks post operatively. 

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Both groups will have elastic bandages applied to control bleeding for the ﬁrst 24 hours 
post-surgery. Afterward, the bandages will be removed in the standard care group, while the 
CPG-EB group will continue using the pressure-guided bandages for the remainder of a 4-
week post-operative period. Patients in the CPG-EB group will be instructed on how to 
properly apply the bandages at the Outpatient Clinic, Room 101, Siammin Building. They will 
be taught to wear the bandages daily (except while sleeping) after discharge and be provided 
with instructions on how to monitor for potential complications and how to address them. 
Both groups will return for follow-up visits at 1-, 2-, and 6-weeks post-surgery to assess 
wound healing, leg swelling, and any complications 
 
Figure 1: Example of Customized Pressure-Guided Elastic Bandages (CPG-EB) 
Source: Sermsathanasawadi N, Chatjaturapat C, Pianchareonsin R, et al. Use of customised pressure-guided elastic bandages 
to improve efficacy of compression bandaging for venous ulcers. Int Wound J. 2017;14:636-640. 

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Figure 1: Patient Protocol During Research Participation 
 
Potential Risks 
Participants in both the standard post-surgical care group and the group treated with 
the customized pressure-guided elastic bandages (CPG-EB) may experience common post-
operative complications such as leg swelling, delayed wound healing, and wound infection. 
These are typical risks for patients undergoing cardiac bypass surgery. However, patients in 
the CPG-EB group may feel discomfort or experience numbness if the bandages are applied 
too tightly or incorrectly. To mitigate this, a nurse will teach participants how to apply the 
bandages properly. If numbness occurs, participants are advised to loosen the bandage and 
review the correct application technique. 
 

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Alternatives to Participation 
Even if patients do not participate in this study, they will still receive the standard 
care for post-surgical wound management following saphenous vein harvesting in coronary 
artery bypass grafting (CABG), which includes elastic bandage application for 24 hours post-
surgery to control bleeding. 
 
Contact for Questions and Adverse Reactions 
For any questions related to the research or if adverse reactions occur, participants can 
contact: 
Dr. Ratcharnon Srifa at +66819660944 or the Surgery OPD, Syamindra Building, Room 101. 
Dr. Prompak Nitayavardhana at +66859141236, or the Surgery OPD, Syamindra Building, Room 
101. 
Medical Care for Research-Related Injuries 
Participants will receive standard medical care for any injuries or illnesses caused by 
the research, with expenses covered by the Faculty of Medicine, Siriraj Hospital. 
 
Expected Beneﬁts of the Research 
1. Professional Beneﬁt: The study may provide insight into the efﬁcacy of customized 
pressure-guided elastic bandages (CPG-EB) in preventing complications after CABG 
surgery. 
2. Social Beneﬁt: Potential reduction in healthcare costs related to post-operative 
complications of saphenous vein harvesting. 
3. Participant Beneﬁt: There are no direct beneﬁts to participants in this study. 
Compensation 
Participants will receive 200 THB as compensation for their involvement in the research. 
There are no additional costs for participants. 
 

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Conﬁdentiality and Data Use 
Personal information will be kept conﬁdential and not disclosed individually. However, 
the overall results may be shared in public reports or through clinical trial websites 
(http://www.ClinicalTrials.gov and http://www.ClinicalTrials.in.th). Certain regulatory 
bodies, such as the funding organization or ethical review board, may access individual 
data to ensure compliance. 
 
Voluntary Participation 
Participants have the right to withdraw from the study at any time without prior notice, 
and doing so will not affect their medical care. 
 
For further understanding of research participation, participants can visit the Siriraj 
Human Research Ethics Committee website at http://www.si.mahidol.ac.th/sirb. 
Complaints can also be directed to the Ethics Committee via this website or by 
contacting the Siriraj Human Research Ethics Ofﬁce at ChalermPhrakiat Building, 2nd 
Floor, or by calling 0 2419 2667-72, 06 3903 4255. 
 
Participant’s Signature: ________________________ 
Name: __________________________ 
Date: __________________________ 
 
Researcher’s Signature: ________________________ 
Name: __________________________ 
Date: __________________________