Asepsis Score, Hematoma, Prolonged Hospital Stay, Readmission Rates, Seroma Following Procedure, Surgical Site Infection (SSI), Surgical Wound Infection
Conditions
Keywords
SSI, single vs multilayer wound closure, ASEPSIS SCORE, CABG, GSV harvesting
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. 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
PROCEDUREMulti-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 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
PROCEDUREsinglelayer closure for leg wound
Multilayer closure for leg wound
Sponsors
National Institute of Cardiovascular Diseases, Pakistan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of postoperative leg wound complications (e.g., infection, hematoma, wound dehiscence, seroma) associated with single-layer vs. multi-layer closure techniques | 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. |
| 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 | 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. |
Countries
Pakistan
Contacts
PRINCIPAL_INVESTIGATORKhuzaima Tariq
National Institute of Cardiovascular Diseases
Outcome results
None listed