Wound ClosurePhase 4NCT07225101
Evaluation of the Efficacy of STRATAFIX for Neurosurgical Cranial and Spine Procedures
A Phase 4 study testing STRATAFIX PDS and Monocryl suture in people with Wound Closure and Brain Tumor Adult, run by University of Michigan at 1 site in United States.
Trial summary
This research is studying a device already approved by the Food and Drug Administration (FDA) to treat wound closures. Researchers are studying a large group of people to continue to learn information about the safety of the STRATAFIX suture and how people's bodies react to using it over a long period of time. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Wound Closure, Brain Tumor Adult, Spine
- What is being tested?
- STRATAFIX PDS and Monocryl suture
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2025to 31 Dec 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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
- Elective or emergent surgical approaches for cranial or spine neurosurgical approaches, requiring sutures for wound closure, requiring multilayer wound closure
Who cannot join
- Patients with prior surgical wound dehiscence or infection
- Patients with allergy to suture material
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Michigan Health Sparrow
Lansing, Michigan, 48912
Karen Sagher, 734-232-4843, kfrisch@med.umich.edu
Michael Karsy, MD, PhD, MSc
About this study
This research is studying a device already approved by the Food and Drug Administration (FDA) to treat wound closures. Researchers are studying a large group of people to continue to learn information about the safety of the STRATAFIX suture and how people's bodies react to using it over a long period of time. This research will provide additional information about using STRATAFIX sutures to close surgical wounds.
- Conditions
- Wound Closure, Brain Tumor Adult, Spine, Neurovascular, Hemorrhagic Stroke, Intracerebral, Traumatic Brain Injury
- Being tested
- STRATAFIX PDS and Monocryl suture
- Keywords
- Superficial surgical site infection, Suture material, Wound closure techniques, brain tumor, spine, spine trauma, neurosurgery, hemorrhagic stroke, traumatic brain injury
- Medical subject headings
- Hemorrhagic Stroke, Brain Injuries, Traumatic, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STRATAFIX PDS and Monocryl sutureDevice
STRATAFIX, suture employs a novel incorporation of barbed components to suture resulting in tension holding closure with long-lasting absorbable suture.
| Study group | Role | What they receive |
|---|---|---|
| STRATAFIX PDS and Monocryl suture | Experimental | All participants enrolled will have their scheduled surgery as planned with their wound closed using STRATAFIX. Receives: Device: STRATAFIX PDS and Monocryl suture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wound complications Bates-Jensen Wound Assessment Tool (BWAT) score
The BWAT evaluates 13 categories including size, depth, edges, undermining, necrotic tissue type and amount, exudate type and amount, skin color, peripheral tissue, granulation tissue and epithelialization with a total score of 65. Minimal severity scores are 10-20 out of the total of 65 with good interrater reliability and validation in a variety of clinical environments. Wounds with scores <10 will be considered healed.
Measured: 1 month
Secondary outcomes (8)
Wound complications Bates-Jensen Wound Assessment Tool (BWAT) score
The BWAT evaluates 13 categories including size, depth, edges, undermining, necrotic tissue type and amount, exudate type and amount, skin color, peripheral tissue, granulation tissue and epithelialization with a total score of 65. Minimal severity scores are 10-20 out of the total of 65 with good interrater reliability and validation in a variety of clinical environments. Wounds with scores <10 will be considered healed.
Scores will be separated into specific patient subgroups (e.g., spine procedures vs. cranial procedures, younger vs. older patients)
Measured: 3 and 6 months
The Wound-Quality of Life (QOL) questionnaire score
This is a 17-point scale with 5 choices each ranging from 17-85. Higher scores indicate worse quality of life.
Measured: 1, 3 and 6 months
Intraoperative time required for wound closure
Time for intraoperative wound closure will be monitored. Wound closure technique will be video recorded.
Measured: Immediately following surgery
Percent of participants positive for superficial surgical site infection (SSI)
Assessed using a culture or polymerase chain reaction
Measured: Up to six months
Number of case deviations and descriptions from prescribed suturing paradigm
A quantification and description for additional suture material required for surgical procedures will be monitored.
Measured: Immediately following surgery
Liker scale of patient satisfaction with wound
10 point subjective scale indicating patient satisfaction with wound
Measured: 1, 3 and 6 months
Wound imaging at perioperative followup
Wound pictures during followup period.
Measured: 1, 3 and 6 months
Wound revision strategy
Description of any wound revision strategies and timing
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2025
- Study start1 Nov 2025
- Primary completion30 Jun 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wound ClosureStudies of the same condition, open and under way.
- More trials run by University of MichiganThe 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Open label, single-arm, non-crossover prospective cohort study with non-inferiority statistical analysis.
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- Johnson & Johnson
- Responsible party
- Principal investigator, Michael Karsy, University of Michigan
- Investigators
- Michael Karsy, MD, PhD, MSc, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07225101
- Sponsor's protocol ID
- HUM00268953
- Status last verified
- Nov 2025
- First submitted
- 3 Nov 2025
- Last updated
- 5 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: Unclear if manuscript will be published in an ICMJE journal and data from this study are restricted from the University of Michigan Data Use Committee
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy of STRATAFIX for Neurosurgical Cranial and Spine Procedures
- ClinicalTrials.gov ID
- NCT07225101
- Acronym / sponsor ID
- HUM00268953
- Conditions
- Wound Closure, Brain Tumor Adult, Spine, Neurovascular, Hemorrhagic Stroke, Intracerebral, Traumatic Brain Injury
- Keywords
- Superficial surgical site infection, Suture material, Wound closure techniques, brain tumor, spine, spine trauma, neurosurgery, hemorrhagic stroke
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- Johnson & Johnson
- Study start
- 1 Nov 2025 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 5 Nov 2025 (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.
This research is studying a device already approved by the Food and Drug Administration (FDA) to treat wound closures. Researchers are studying a large group of people to continue to learn information about the safety of the STRATAFIX suture and how people's bodies react to using it over a long period of time. This research will provide additional information about using STRATAFIX sutures to close surgical wounds.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open label, single-arm, non-crossover prospective cohort study with non-inferiority statistical analysis.
| Arm | Type | Receives |
|---|---|---|
| STRATAFIX PDS and Monocryl suture | Experimental | Device: STRATAFIX PDS and Monocryl sutureAll participants enrolled will have their scheduled surgery as planned with their wound closed using STRATAFIX. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Elective or emergent surgical approaches for cranial or spine neurosurgical approaches, requiring sutures for wound closure, requiring multilayer wound closure
Key exclusion criteria (2 listed)
- Patients with prior surgical wound dehiscence or infection
- Patients with allergy to suture material
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 |
|---|---|---|
| STRATAFIX PDS and Monocryl sutureSTRATAFIX, suture employs a novel incorporation of barbed components to suture resulting in tension holding closure with long-lasting absorbable suture. | Device | STRATAFIX PDS and Monocryl suture |
Primary outcome
Wound complications Bates-Jensen Wound Assessment Tool (BWAT) score
Time frame: 1 month
The BWAT evaluates 13 categories including size, depth, edges, undermining, necrotic tissue type and amount, exudate type and amount, skin color, peripheral tissue, granulation tissue and epithelialization with a total score of 65. Minimal severity scores are 10-20 out of the total of 65 with good interrater reliability and validation in a variety of clinical environments. Wounds with scores <10 will be considered healed.
8 secondary outcomes
Wound complications Bates-Jensen Wound Assessment Tool (BWAT) score
Time frame: 3 and 6 months
The Wound-Quality of Life (QOL) questionnaire score
Time frame: 1, 3 and 6 months
Intraoperative time required for wound closure
Time frame: Immediately following surgery
Percent of participants positive for superficial surgical site infection (SSI)
Time frame: Up to six months
Number of case deviations and descriptions from prescribed suturing paradigm
Time frame: Immediately following surgery
Liker scale of patient satisfaction with wound
Time frame: 1, 3 and 6 months
Wound imaging at perioperative followup
Time frame: 1, 3 and 6 months
Wound revision strategy
Time frame: up to 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2025.
- Individual participant dataSharing planned: Undecided. Unclear if manuscript will be published in an ICMJE journal and data from this study are restricted from the University of Michigan Data Use Committee
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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.
Michael Karsy, MD, PhD, MSc principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing STRATAFIX PDS and Monocryl suture in people with Wound Closure and Brain Tumor Adult, run by University of Michigan 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 1 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 5 Nov 2025. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Karen Sagher (734-232-4843, kfrisch@med.umich.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wound complications Bates-Jensen Wound Assessment Tool (BWAT) score (time frame: 1 month). 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 5 Nov 2025.