Wound Closure Techniques in Primary Spine Surgery

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

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.

Study Overview

• Status: Completed
• Conditions: Spinal Injuries
• Intervention / Treatment: Procedure: Closure technique

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Arjun Sebastian, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2019
• Primary Completion (Actual): July 21, 2025
• Study Completion (Actual): July 21, 2025

Study Registration Dates

• First Submitted: February 17, 2020
• First Submitted That Met QC Criteria: May 17, 2020
• First Posted (Actual): May 20, 2020

Study Record Updates

• Last Update Posted (Actual): April 17, 2026
• Last Update Submitted That Met QC Criteria: April 14, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Back Injuries; Spinal Injuries
• Other Study ID Numbers: 18-011744

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No