Surgical Wound InfectionCABGNCT07355452
Comparing Outcomes Of Single Layer Versus Multilayer Leg Closure Techniques Following Great Saphenous Vein Harvesting For CABG
A study testing Multi-layer closure (MLC) and singlelayer closure for leg wound in people with Surgical Wound Infection and Hematoma, run by National Institute of Cardiovascular Diseases, Pakistan at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Surgical Wound Infection, Hematoma, Seroma Following Procedure
- What is being tested?
- Multi-layer closure (MLC) and singlelayer closure for leg wound
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 sitePakistan
- Study dates
- 30 Jun 2025to 30 Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site
National Institute of cardiovascular diseases
Karachi, Sindh, 75510
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.
Read the 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:
- 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
- Conditions
- Surgical Wound Infection, Hematoma, Seroma Following Procedure, Prolonged Hospital Stay, Readmission Rates, Asepsis Score
- Being tested
- Multi-layer closure (MLC), singlelayer closure for leg wound
- Keywords
- SSI, single vs multilayer wound closure, ASEPSIS SCORE, CABG, GSV harvesting
- Medical subject headings
- Surgical Wound Infection, Hematoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multi-layer closure (MLC)Procedure or surgery
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 woundProcedure or surgery
Multilayer closure for leg wound
| Study group | Role | What they receive |
|---|---|---|
| Multi-layer Closure(MLC) | Active comparator | Multi-layer Closure: multi-layer closure after great saphenous vein harvesting for CABG Receives: Procedure: Multi-layer closure (MLC) |
| Single-layer Closure(SLC) | Experimental | Single-layer Closure: single-layer closure after great saphenous vein harvesting for CABG Receives: Procedure: singlelayer closure for leg wound |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2026
- Study start30 Jun 2025
- Primary completion25 Feb 2026 (estimated)
- Study completion30 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical Wound InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Institute of Cardiovascular Diseases, Pakistan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr khuzaima Tariq, National Institute of Cardiovascular Diseases, Pakistan
- Investigators
- Khuzaima Tariq, Principal investigator, National Institute of Cardiovascular Diseases
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07355452
- Sponsor's protocol ID
- IRB-54/2025
- Other IDs
- no funding/grants
- Acronym
- CABG
- Status last verified
- Jan 2026
- First submitted
- 1 Dec 2025
- Last updated
- 21 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Outcomes Of Single Layer Versus Multilayer Leg Closure Techniques Following Great Saphenous Vein Harvesting For CABG
- ClinicalTrials.gov ID
- NCT07355452
- Acronym / sponsor ID
- CABG / IRB-54/2025
- Conditions
- Surgical Wound Infection, Hematoma, Seroma Following Procedure, Prolonged Hospital Stay, Readmission Rates, Asepsis Score
- Keywords
- SSI, single vs multilayer wound closure, ASEPSIS SCORE, CABG, GSV harvesting
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- National Institute of Cardiovascular Diseases, PakistanUniversity, hospital or other
- Study start
- 30 Jun 2025 (actual)
- Primary completion
- 25 Feb 2026 (estimated)
- Study completion
- 30 Mar 2026 (estimated)
- First posted
- 21 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- 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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multi-layer Closure(MLC) | Active comparator | Procedure: Multi-layer closure (MLC)Multi-layer Closure: multi-layer closure after great saphenous vein harvesting for CABG |
| Single-layer Closure(SLC) | Experimental | Procedure: singlelayer closure for leg woundSingle-layer Closure: single-layer closure after great saphenous vein harvesting for CABG |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 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 | Procedure or surgery | Multi-layer Closure(MLC) |
| singlelayer closure for leg woundMultilayer closure for leg wound | Procedure or surgery | Single-layer Closure(SLC) |
Primary outcome
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Khuzaima Tariq principal investigator
National Institute of Cardiovascular Diseases
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multi-layer closure (MLC) and singlelayer closure for leg wound in people with Surgical Wound Infection and Hematoma, run by National Institute of Cardiovascular Diseases, Pakistan at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2026.