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Enrolling by invitation NCT07355452

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

No phase Interventional Surgical Wound Infection Hematoma Seroma Following Procedure Prolonged Hospital Stay

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Multi-layer closure (MLC), singlelayer closure for leg wound.
Who it may be relevant to
Registry conditions: Surgical Wound Infection, Hematoma, Seroma Following Procedure, Prolonged Hospital Stay. Basic parameters: 18 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Pakistan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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.

Detailed 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

Interventions

  • Procedure Multi-layer closure (MLC)
    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 a
  • Procedure singlelayer closure for leg wound
    Multilayer closure for leg wound

Primary outcome measures

  • 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]
  • 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]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Pakistan · 1 center
  • National Institute of cardiovascular diseases — Karachi

Identifiers

NCT: NCT07355452 · IRB-54/2025 · no funding/grants

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗