Wound Closure Techniques in Primary Spine Surgery

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

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04396613

Enrollment

Registered

2020-05-20

Start date

2019-04-01

Completion date

2025-07-21

Last updated

2026-04-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spinal Injuries

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.

Interventions

PROCEDUREClosure technique

Randomized assignment to one of three known, effective closure techniques

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
Lowest perfusion - 10 Alongside	At time of procedure	Lowest perfusion score per 10 measurements taken along the wound closure
Average perfusion - 10 Alongside	At time of procedure	Average perfusion score per 10 measurements taken along the wound closure
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 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)
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.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORArjun Sebastian

Mayo Clinic

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 18, 2026