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NCT Number: NCT07355452

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

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.

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Key information

Conditions

Surgical Wound Infection Asepsis Score Hematoma Hemorrhage Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Prolonged Hospital Stay Readmission Rates Seroma Following Procedure Surgical Site Infection (SSI) Wound Infection

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Institute of cardiovascular diseases

Karachi, Sindh, 75510, Pakistan

About this study

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:

  • Does single-layer closure compared to multi-layer closure result in better postoperative outcomes in patients undergoing great saphenous vein harvesting for CABG
  • 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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

singlelayer closure for leg wound

Procedure

Multilayer closure for leg wound

Primary outcomes

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

    Time frame: 7 days

    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.

  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

    Time frame: 14 days

    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.

Sponsors and collaborators

Lead sponsor

National Institute of Cardiovascular Diseases, Pakistan

Other

Registry information

Acronym: CABG

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 21, 2026
Registry last updated
Jan 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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