ClinicalTrials.gg
CompletedNCT04396613Updated Apr 17, 2026

Wound Closure Techniques in Primary Spine Surgery

An interventional study of Closure technique in Spinal Injuries, sponsored by Mayo Clinic. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-17.

Sponsored by Mayo Clinic · Not applicable, Interventional, and Other

From the registry’s dates

  • Registered 10 months after the study started (first participant enrolled Apr 2019, registered Feb 2020).
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Spinal Injuries

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03

In context

Spinal Injuries

57 studies on the registry are indexed under Spinal Injuries; 15 are open to participants now.

This study's enrollment of 50 is close to the median of 52 across 31 interventional studies indexed under Spinal Injuries.

Browse Spinal Injuries studies →

Lead sponsor

Mayo Clinic is the lead sponsor of 3,269 studies on the registry; 672 are open to participants now.

Of its 452 completed or terminated interventional studies of FDA-regulated products, 321 (71%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Pregnant or Breastfeeding
  • Previous posterior spinal surgery
  • Systemic 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 , , or Syphilis
  • Iodine Allergy
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
50 participants (actual)

Study arms

  • Active comparator
    Running Subcuticular Suture

    Procedure: Closure technique

  • Active comparator
    Interrupted Vertical Mattress Suture

    Procedure: Closure technique

  • Active comparator
    Staple Closure Techniques

    Procedure: Closure technique

Interventions

  • ProcedureClosure technique

    Randomized assignment to one of three known, effective closure techniques

06

What researchers measure

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).

    Time frame: Baseline

Secondary outcomes

  1. Lowest perfusion - 10 Alongside

    Lowest perfusion score per 10 measurements taken along the wound closure

    Time frame: At time of procedure

  2. Average perfusion - 10 Alongside

    Average perfusion score per 10 measurements taken along the wound closure

    Time frame: At time of procedure

  3. 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).

    Time frame: At time of procedure

  4. 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)

    Time frame: At time of procedure

  5. Lowest perfusion - 20 Sides

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

    Time frame: At time of procedure

  6. Average perfusion - 20 Sides

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

    Time frame: At time of procedure

07

Study locations

1 site
  • Mayo Clinic
    Rochester, Minnesota 55905, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Apr 2019 to primary completion in Jul 2025, 75 months.

Of 23 interventional studies with no phase under Spinal Injuries, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 75. This study's 75 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 17, 2020
First posted
May 20, 2020
StartActual
Apr 1, 2019
Primary completionActual
Jul 21, 2025
CompletionActual
Jul 21, 2025
Last update
Apr 17, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 17, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04396613
Lead sponsor
Mayo Clinic
Responsible party
Arjun S. Sebastian (Principal Investigator, Mayo Clinic) — Principal investigator
First posted
May 20, 2020
Start date
Apr 1, 2019
Primary completion
Jul 21, 2025
Completion
Jul 21, 2025
Last update
Apr 17, 2026

Study contacts

Arjun Sebastian
principal investigator · Mayo Clinic

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

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