NCT04396613

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2019

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

February 17, 2020

Completed
3 months until next milestone

First Posted

Study publicly available on registry

May 20, 2020

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 21, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 21, 2025

Completed
Last Updated

April 17, 2026

Status Verified

April 1, 2026

Enrollment Period

6.3 years

First QC Date

February 17, 2020

Last Update Submit

April 14, 2026

Conditions

Spinal Injuries

Outcome Measures

Primary Outcomes (1)

  • 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).

    Baseline

Secondary Outcomes (6)

  • Lowest perfusion - 10 Alongside

    At time of procedure

  • Average perfusion - 10 Alongside

    At time of procedure

  • Average perfusion - 10 Adjacent

    At time of procedure

  • Lowest perfusion - 20 Adjacent

    At time of procedure

  • Lowest perfusion - 20 Sides

    At time of procedure

  • +1 more secondary outcomes

Study Arms (3)

Running Subcuticular Suture

ACTIVE COMPARATOR
Procedure: Closure technique

Interrupted Vertical Mattress Suture

ACTIVE COMPARATOR
Procedure: Closure technique

Staple Closure Techniques

ACTIVE COMPARATOR
Procedure: Closure technique

Interventions

Closure techniquePROCEDURE

Randomized assignment to one of three known, effective closure techniques

Interrupted Vertical Mattress SutureRunning Subcuticular SutureStaple Closure Techniques

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ≥ 18 years old
  • Primary diagnosis of spinal stenosis
  • Surgical indication for 1 or 2 level posterior spinal decompression or fusion

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Spinal Injuries

Condition Hierarchy (Ancestors)

Back InjuriesWounds and Injuries

Study Officials

  • Arjun Sebastian

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 17, 2020

First Posted

May 20, 2020

Study Start

April 1, 2019

Primary Completion

July 21, 2025

Study Completion

July 21, 2025

Last Updated

April 17, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)