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

NCT07355452 | Enrolling By Invitation DMC

• 2 other identifiers: IRB-54/2025no funding/grants
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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. 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. 2.To evaluate the incidence of postoperative complications (e.g., infection, hematoma, wound dehiscence, seroma) associated with single-layer vs. multi-layer closure techniques.

Conditions

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

Keywords

SSI; single vs multilayer wound closure; ASEPSIS SCORE; CABG; GSV harvesting

Outcome Measures

Primary Outcomes (2)

• Incidence of postoperative leg wound complications (e.g., infection, hematoma, wound dehiscence, seroma) associated with single-layer vs. multi-layer closure techniques

  Number of patients enrolled in each group will be assessed for incidence of postoperative complications (e.g., infection, hematoma, wound dehiscence, seroma) associated with single-layer vs multilayer closure techniques using ASEPSIS score. Primary outcomes noticed in both arms will be compared within first 7 days postoperatively. A validated tool called ASEPSIS score will be used and score will be calculated for all patients registered in this study.

  7 days

• 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

  Number of patients enrolled in each group will be assessed for incidence of postoperative complications (e.g., infection, hematoma, wound dehiscence, seroma) associated with single-layer vs multilayer closure techniques using ASEPSIS score. Primary outcomes noticed in both arms will be compared within first 7 days postoperatively. A validated tool called ASEPSIS score will be used and score will be calculated for all patients registered in this study.

  14 days

Study Arms (2)

Multi-layer Closure(MLC)

ACTIVE COMPARATOR

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

Procedure: Multi-layer closure (MLC)

Single-layer Closure(SLC)

EXPERIMENTAL

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

Procedure: singlelayer closure for leg wound

Interventions

Multi-layer closure (MLC) PROCEDURE

Coronary artery bypass grafting remains a cornerstone in the management of coronary artery disease, with frequent use of the great saphenous vein as a conduit. While surgical techniques for vein harvesting have evolved, the optimal closure method for the resulting incision remains controversial . The technique employed for closure after vein harvesting can vary, with single-layer and multi-layer closure techniques . Multi-layer closure has remained a standard approach providing adequate tissue approximation and wound healing . However, in recent years, single-layer closure with suction drainage has emerged as a potential alternative, with proponents suggesting it may lead to improved wound healing, reduced complications, and enhanced patient outcomes

Multi-layer Closure(MLC)

singlelayer closure for leg wound PROCEDURE

Multilayer closure for leg wound

Single-layer Closure(SLC)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Institute of Cardiovascular Diseases, Pakistan: lead

Study Sites (1)

National Institute of cardiovascular diseases

Karachi, Sindh, 75510, Pakistan

Location

MeSH Terms

Conditions

Surgical Wound Infection; Hematoma

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hemorrhage

Study Officials

• Khuzaima Tariq

  National Institute of Cardiovascular Diseases

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor and program Director (cardiac surgery training)

Study Record Dates

• First Submitted: December 1, 2025
• First Posted: January 21, 2026
• Study Start: June 30, 2025
• Primary Completion: February 25, 2026
• Study Completion: March 30, 2026
• Last Updated: January 21, 2026

Record last verified: 2026-01

Locations

PA (1)