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OpenTrials
Completed

NCT Number: NCT04396613

Wound Closure Techniques in Primary Spine Surgery

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.

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Key information

Conditions

Spinal Injuries Back Injuries Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Closure technique

Procedure

Randomized assignment to one of three known, effective closure techniques

Primary outcomes

  1. 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 outcomes

  1. Lowest perfusion - 10 Alongside

    Time frame: At time of procedure

    Lowest perfusion score per 10 measurements taken along the wound closure

  2. Average perfusion - 10 Alongside

    Time frame: At time of procedure

    Average perfusion score per 10 measurements taken along the wound closure

  3. 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).

  4. 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)

  5. 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.

  6. 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.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2025
Study completion
2025
First posted
May 20, 2020
Registry last updated
Apr 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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