Wound Closure Techniques in Primary Spine Surgery

Spinal Injuries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04396613
• Other study ID #: 18-011744
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2019
• Est. completion date: March 2025

Study information

• Verified date: April 2024
• Source: Mayo Clinic
• Contact: Cassandra Willson
• Phone: 507-293-4290
• Email: Kingsbury.Cassandra[@]mayo.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 147
• Est. completion date: March 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Spinal Injuries

Intervention

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

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Lowest perfusion - 10 Alongside	Lowest perfusion score per 10 measurements taken along the wound closure	At time of procedure
Secondary	Average perfusion - 10 Alongside	Average perfusion score per 10 measurements taken along the wound closure	At time of procedure
Secondary	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
Secondary	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
Secondary	Lowest perfusion - 20 Sides	Lowest perfusion score per 20 measurements taken 1cm on either side of the wound closure.	At time of procedure
Secondary	Average perfusion - 20 Sides	Average perfusion score per 20 measurements taken 1cm on either side of the wound closure.	At time of procedure