Wound Closure Techniques in Primary Spine Surgery

NCT ID: NCT04396613

Last Updated: 2025-05-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

147 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-01

Study Completion Date

2026-03-31

Brief Summary

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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

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Conditions

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Spinal Injuries

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

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Running Subcuticular Suture

Group Type ACTIVE_COMPARATOR

Closure technique

Intervention Type PROCEDURE

Randomized assignment to one of three known, effective closure techniques

Interrupted Vertical Mattress Suture

Group Type ACTIVE_COMPARATOR

Closure technique

Intervention Type PROCEDURE

Randomized assignment to one of three known, effective closure techniques

Staple Closure Techniques

Group Type ACTIVE_COMPARATOR

Closure technique

Intervention Type PROCEDURE

Randomized assignment to one of three known, effective closure techniques

Interventions

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Closure technique

Randomized assignment to one of three known, effective closure techniques

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Arjun S. Sebastian

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Arjun Sebastian

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic

Rochester, Minnesota, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Cassandra Willson

Role: CONTACT

507-293-4290

Facility Contacts

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Cassandra Willson

Role: primary

Other Identifiers

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18-011744

Identifier Type: -

Identifier Source: org_study_id

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