Wound Closure Techniques in Primary Spine Surgery

Not Applicable

Recruiting

• Conditions: Spinal Injuries

• Registration Number: NCT04396613
• Lead Sponsor: Mayo Clinic

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-04-01
• Study First Submitted: 2020-02-17
• Study First Submitted QC: 2020-05-17
• Study First Posted: 2020-05-20
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-05
• Last Update Posted: 2025-05-08
• Primary Completion: 2026-03
• Study Completion: 2026-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 147

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Lowest perfusion - 10 Adjacent	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 Outcome Measures

Name	Time	Method
Average perfusion - 10 Adjacent	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 Sides	At time of procedure	Lowest perfusion score per 20 measurements taken 1cm on either side of the wound closure.
Average perfusion - 20 Sides	At time of procedure	Average perfusion score per 20 measurements taken 1cm on either side of the wound closure.
Lowest perfusion - 10 Alongside	At time of procedure	Lowest perfusion score per 10 measurements taken along the wound closure
Lowest perfusion - 20 Adjacent	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)
Average perfusion - 10 Alongside	At time of procedure	Average perfusion score per 10 measurements taken along the wound closure

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States