Comparing Outcomes Of Single Layer Versus Multilayer Leg Closure Techniques Following Great Saphe… (NCT07355452) | Clinical Trial Compass
By InvitationNot Applicable
Comparing Outcomes Of Single Layer Versus Multilayer Leg Closure Techniques Following Great Saphenous Vein Harvesting For CABG
Pakistan200 participantsStarted 2025-06-30
Plain-language summary
This study aims to address the knowledge gap by comparing the outcomes of single-layer and multi-layer leg closure techniques following great saphenous vein harvesting for Coronary artery bypass grafting.
Research question:
1. Does single-layer closure compared to multi-layer closure result in better postoperative outcomes in patients undergoing great saphenous vein harvesting for CABG
2. To evaluate the incidence of postoperative complications (e.g., infection, hematoma, wound dehiscence, seroma) associated with single-layer vs. multi-layer closure techniques.
participants will follow in OPD after 1 week , their wounds will be examined and assessment will be recorded.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Sample Selection Sampling Technique: Non-probability consecutive sampling
Inclusion Criteria:
* elective CABG
* Both male and female patients
* Patient of age between 18-70 years
* Patients of consenting surgeons will be included in the study after elaboration of study protocol
Exclusion Criteria:
* Patients with previous leg surgery,
* peripheral vascular disease,
* obesity, BMI; \>30kg/m 2 .(weight in kilogram, height in meters)
* varicose veins
* those undergoing total arterial revascularization
* emergency CABG
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is comparing single-layer versus multi-layer closure of the leg wound after the vein is harvested for bypass surgery — how does my surgeon currently close that wound, and do they think one approach might reduce my personal risk of infection or fluid buildup?
2Since this trial is Phase NA and is directly comparing two existing surgical techniques rather than testing a new drug or device, what does my care team already know about the safety record of each closure method, and are there any patients for whom one approach tends to work better?
3The trial tracks complications like hematoma, seroma, wound dehiscence, and readmission — given my own health history, am I at higher-than-average risk for any of those leg wound problems after vein harvesting, and should that influence which closure technique is used on me?
4This study is enrolling by invitation only — how are patients being selected, and is participation something my surgical team could discuss with me before my procedure, or has the decision about my closure technique already been made?
5If I don't participate in this trial, will my surgeon still choose a closure technique based on the best current evidence, and is there any meaningful difference in my care or follow-up depending on whether I'm included in the study?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of postoperative leg wound complications (e.g., infection, hematoma, wound dehiscence, seroma) associated with single-layer vs. multi-layer closure techniques
Timeframe: 7 days
2
Incidence of postoperative leg wound complications (e.g., infection, hematoma, wound dehiscence, seroma, re-suturing, readmission) associated with single-layer vs. multi-layer closure techniques
Timeframe: 14 days
Trial details
NCT IDNCT07355452
SponsorNational Institute of Cardiovascular Diseases, Pakistan