Comparing Outcomes Of Single Layer Versus Multilayer Leg Closure Techniques Following Great Saphenous Vein Harvesting For CABG

National Institute of Cardiovascular Diseases, Pakistan

Status: Invitation-only

Conditions: Asepsis Score; Prolonged Hospital Stay; Surgical Site Infection (SSI); Readmission Rates; Seroma Following Procedure; Surgical Wound Infection; Hematoma

Treatments: Procedure: Multi-layer closure (MLC); Procedure: singlelayer closure for leg wound

Study type: Interventional

Funder types: Other

Identifiers

NCT07355452

IRB-54/2025

no funding/grants (Other Identifier)

Details and patient eligibility

About

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.

Full description

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.

Primary Endpoints: ASEPSIS SCORE Secondary Endpoints: Length of hospital stay, infection, hematoma, wound dehiscence, seroma Follow-up at 2 weeks. Readmission for leg wound complications or interventions

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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200 participants in 2 patient groups

Multi-layer Closure(MLC)

Active Comparator group

Description:

Multi-layer Closure: multi-layer closure after great saphenous vein harvesting for CABG

Treatment:

Procedure: Multi-layer closure (MLC)

Single-layer Closure(SLC)

Experimental group

Description:

Single-layer Closure: single-layer closure after great saphenous vein harvesting for CABG

Treatment:

Procedure: singlelayer closure for leg wound