Wound Closure Techniques in Primary Spine Surgery

Overview

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.

Full Title of Study: “Assessment of Wound Closure Techniques in Primary Spine Surgery Using SPY Intra-operative Angiography”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Other
    • Masking: Single (Participant)
  • Study Primary Completion Date: December 31, 2021

Interventions

  • Procedure: Closure technique
    • Randomized assignment to one of three known, effective closure techniques

Arms, Groups and Cohorts

  • Active Comparator: Running Subcuticular Suture
  • Active Comparator: Interrupted Vertical Mattress Suture
  • Active Comparator: Staple Closure Techniques

Clinical Trial Outcome Measures

Primary Measures

  • Lowest perfusion – 10 Adjacent
    • Time Frame: Baseline
    • Lowest perfusion score per 10 measurements taken along the wound closure as a percentage of perfusion at a standard location (5cm above incision).

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Mayo Clinic
  • Provider of Information About this Clinical Study
    • Principal Investigator: Arjun S. Sebastian, Principal Investigator – Mayo Clinic
  • Overall Official(s)
    • Arjun Sebastian, Principal Investigator, Mayo Clinic
  • Overall Contact(s)
    • Ashley Xiong, 507-293-7612, Xiong.Ashley@mayo.edu

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