Wound Closure Techniques in Primary Spine Surgery

Study Overview
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Brief Summary
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The Researchers are trying to determine if there is a difference in blood flow around a wound site when comparing three different types of wound closure techniques.

Official Title
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Assessment of Wound Closure Techniques in Primary Spine Surgery Using SPY Intra-operative Angiography

Conditions
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Spinal Injuries

Intervention / Treatment
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* Procedure: Closure technique


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ≥ 18 years old Primary diagnosis of spinal stenosis Surgical indication for 1 or 2 level posterior spinal decompression or fusion Exclusion Criteria: Pregnant or Breastfeeding Previous posterior spinal surgery Systemic corticosteroid use Long-term anticoagulation treatment Diagnosis of diabetes mellitus Diagnosis of peripheral arterial disease Current smoker Active infection of any kind or chronic infection with HIV, Hepatitis C, or Syphilis Iodine Allergy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Running Subcuticular Suture<br> | Procedure: Closure technique<br>* Randomized assignment to one of three known, effective closure techniques<br>|
| Active Comparator: Interrupted Vertical Mattress Suture<br> | Procedure: Closure technique<br>* Randomized assignment to one of three known, effective closure techniques<br>|
| Active Comparator: Staple Closure Techniques<br> | Procedure: Closure technique<br>* Randomized assignment to one of three known, effective closure techniques<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lowest perfusion - 10 Adjacent | Lowest perfusion score per 10 measurements taken along the wound closure as a percentage of perfusion at a standard location (5cm above incision). | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lowest perfusion - 10 Alongside | Lowest perfusion score per 10 measurements taken along the wound closure | At time of procedure | 
| Average perfusion - 10 Alongside | Average perfusion score per 10 measurements taken along the wound closure | At time of procedure | 
| Average perfusion - 10 Adjacent | Average perfusion score per 10 measurements taken along the wound closure as a percentage of perfusion at a standard location (5cm above incision). | At time of procedure | 
| Lowest perfusion - 20 Adjacent | Lowest perfusion score per 20 measurements taken 1cm on either side of the wound closure as a percentage of perfusion at a standard location (5cm above incision) | At time of procedure | 
| Lowest perfusion - 20 Sides | Lowest perfusion score per 20 measurements taken 1cm on either side of the wound closure. | At time of procedure | 
| Average perfusion - 20 Sides | Average perfusion score per 20 measurements taken 1cm on either side of the wound closure. | At time of procedure |