Spinal InjuriesNCT04396613
Wound Closure Techniques in Primary Spine Surgery
A study testing Closure technique in people with Spinal Injuries, run by Mayo Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Injuries
- What is being tested?
- Closure technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2019to 21 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 18 years old
- Primary diagnosis of spinal stenosis
- Surgical indication for 1 or 2 level posterior spinal decompression or fusion
Who cannot join
- Pregnant or Breastfeeding
- Previous posterior spinal surgery
- Systemic corticosteroid use
- Long-term anticoagulation treatment
- Diagnosis of diabetes mellitus
- Diagnosis of peripheral arterial disease
Show all 9Show fewer
- Current smoker
- Active infection of any kind or chronic infection with HIV, Hepatitis C, or Syphilis
- Iodine Allergy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Spinal Injuries
- Being tested
- Closure technique
- Medical subject headings
- Spinal Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Closure techniqueProcedure or surgery
Randomized assignment to one of three known, effective closure techniques
| Study group | Role | What they receive |
|---|---|---|
| Running Subcuticular Suture | Active comparator | Not described Receives: Procedure: Closure technique |
| Interrupted Vertical Mattress Suture | Active comparator | Not described Receives: Procedure: Closure technique |
| Staple Closure Techniques | Active comparator | Not described Receives: Procedure: Closure technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline
Secondary outcomes (6)
Lowest perfusion - 10 Alongside
Lowest perfusion score per 10 measurements taken along the wound closure
Measured: At time of procedure
Average perfusion - 10 Alongside
Average perfusion score per 10 measurements taken along the wound closure
Measured: At time of procedure
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).
Measured: At time of procedure
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)
Measured: At time of procedure
Lowest perfusion - 20 Sides
Lowest perfusion score per 20 measurements taken 1cm on either side of the wound closure.
Measured: At time of procedure
Average perfusion - 20 Sides
Average perfusion score per 20 measurements taken 1cm on either side of the wound closure.
Measured: At time of procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2020
- Study start1 Apr 2019
- Primary completion21 Jul 2025
- Study completion21 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal InjuriesStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arjun S. Sebastian, Mayo Clinic
- Investigators
- Arjun Sebastian, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04396613
- Sponsor's protocol ID
- 18-011744
- Status last verified
- Apr 2026
- First submitted
- 17 Feb 2020
- Last updated
- 17 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Wound Closure Techniques in Primary Spine Surgery Using SPY Intra-operative Angiography
- ClinicalTrials.gov ID
- NCT04396613
- Acronym / sponsor ID
- 18-011744
- Conditions
- Spinal Injuries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 21 Jul 2025 (actual)
- Study completion
- 21 Jul 2025 (actual)
- First posted
- 20 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ≥ 18 years old
- Primary diagnosis of spinal stenosis
- Surgical indication for 1 or 2 level posterior spinal decompression or fusion
Key exclusion criteria (9 listed)
- Pregnant or Breastfeeding
- Previous posterior spinal surgery
- Systemic corticosteroid use
- Long-term anticoagulation treatment
- Diagnosis of diabetes mellitus
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Closure techniqueRandomized assignment to one of three known, effective closure techniques | Procedure or surgery | Interrupted Vertical Mattress Suture, Running Subcuticular Suture, Staple Closure Techniques |
Primary outcome
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).
6 secondary outcomes
Lowest perfusion - 10 Alongside
Time frame: At time of procedure
Average perfusion - 10 Alongside
Time frame: At time of procedure
Average perfusion - 10 Adjacent
Time frame: At time of procedure
Lowest perfusion - 20 Adjacent
Time frame: At time of procedure
Lowest perfusion - 20 Sides
Time frame: At time of procedure
Average perfusion - 20 Sides
Time frame: At time of procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arjun Sebastian principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Closure technique in people with Spinal Injuries, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lowest perfusion - 10 Adjacent (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2026.