Clinical trial · Interventional
Evaluation of the Efficacy of STRATAFIX for Neurosurgical Cranial and Spine Procedures
NCT07225101CI-TRIAL-00096997recruitingPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain Tumor Adult | Brain Neoplasm | ALIAS | 0.85 |
| Hemorrhagic Stroke, Intracerebral | — | UNRESOLVED | — |
| Neurovascular | — | UNRESOLVED | — |
| Spine | — | UNRESOLVED | — |
| Traumatic Brain Injury | — | UNRESOLVED | — |
| Wound Closure | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| STRATAFIX PDS and Monocryl suture | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- STRATAFIX PDS and Monocryl suture
- description
- All participants enrolled will have their scheduled surgery as planned with their wound closed using STRATAFIX.
- interventionNames
- Device: STRATAFIX PDS and Monocryl suture
Primary outcomes (1)
- measure
- Wound complications Bates-Jensen Wound Assessment Tool (BWAT) score
- timeFrame
- 1 month
- description
- 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.
Secondary outcomes (8)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Elective or emergent surgical approaches for cranial or spine neurosurgical approaches, requiring sutures for wound closure, requiring multilayer wound closure Exclusion Criteria: * Patients with prior surgical wound dehiscence or infection * Patients with allergy to suture material
References
Publications (0)
Data not yet available
No reference posted for this study.