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Wound Closure Techniques in Primary Spine Surgery

Primary Purpose

Spinal Injuries

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Closure technique

About this trial

This is an interventional other trial for Spinal Injuries

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Mayo ClinicRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Arm Label

Running Subcuticular Suture

Interrupted Vertical Mattress Suture

Staple Closure Techniques

Arm Description

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Lowest perfusion - 10 Alongside

Lowest perfusion score per 10 measurements taken along the wound closure

Average perfusion - 10 Alongside

Average perfusion score per 10 measurements taken along the wound closure

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).

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)

Lowest perfusion - 20 Sides

Lowest perfusion score per 20 measurements taken 1cm on either side of the wound closure.

Average perfusion - 20 Sides

Average perfusion score per 20 measurements taken 1cm on either side of the wound closure.

Full Information

NCT ID

NCT04396613

First Posted

February 17, 2020

Last Updated

March 31, 2023

Sponsor

Mayo Clinic

1. Study Identification

Unique Protocol Identification Number

NCT04396613

Brief Title

Wound Closure Techniques in Primary Spine Surgery

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Recruiting

Study Start Date

April 1, 2019 (Actual)

Primary Completion Date

March 2025 (Anticipated)

Study Completion Date

March 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Mayo Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Spinal Injuries

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

147 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Running Subcuticular Suture

Arm Type

Active Comparator

Arm Title

Interrupted Vertical Mattress Suture

Arm Type

Active Comparator

Arm Title

Staple Closure Techniques

Arm Type

Active Comparator

Intervention Type

Procedure

Intervention Name(s)

Closure technique

Intervention Description

Randomized assignment to one of three known, effective closure techniques

Primary Outcome Measure Information:

Title

Lowest perfusion - 10 Adjacent

Description

Lowest perfusion score per 10 measurements taken along the wound closure as a percentage of perfusion at a standard location (5cm above incision).

Time Frame

Baseline

Secondary Outcome Measure Information:

Title

Lowest perfusion - 10 Alongside

Description

Lowest perfusion score per 10 measurements taken along the wound closure

Time Frame

At time of procedure

Title

Average perfusion - 10 Alongside

Description

Average perfusion score per 10 measurements taken along the wound closure

Time Frame

At time of procedure

Title

Average perfusion - 10 Adjacent

Description

Average perfusion score per 10 measurements taken along the wound closure as a percentage of perfusion at a standard location (5cm above incision).

Time Frame

At time of procedure

Title

Lowest perfusion - 20 Adjacent

Description

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)

Time Frame

At time of procedure

Title

Lowest perfusion - 20 Sides

Description

Lowest perfusion score per 20 measurements taken 1cm on either side of the wound closure.

Time Frame

At time of procedure

Title

Average perfusion - 20 Sides

Description

Average perfusion score per 20 measurements taken 1cm on either side of the wound closure.

Time Frame

At time of procedure

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Cassandra Willson

Phone

507-293-4290

Kingsbury.Cassandra@mayo.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Arjun Sebastian

Organizational Affiliation

Mayo Clinic

Official's Role

Principal Investigator

Facility Information:

Facility Name

Mayo Clinic

City

Rochester

State/Province

Minnesota

ZIP/Postal Code

55905

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Cassandra Willson

Kingsbury.Cassandra@mayo.edu

12. IPD Sharing Statement

Links:

URL

https://www.mayo.edu/research/clinical-trials

Description

Mayo Clinic Clinical Trials

Learn more about this trial

Wound Closure Techniques in Primary Spine Surgery

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