Wound Closure Techniques in Primary Spine Surgery

April 18, 2024 updated by: Arjun S. Sebastian, Mayo Clinic

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

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

147

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Arjun Sebastian, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2019

Primary Completion (Estimated)

March 1, 2025

Study Completion (Estimated)

March 1, 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 22, 2024

Last Update Submitted That Met QC Criteria

April 18, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18-011744

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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