RECRUITINGPhase 4INTERVENTIONAL
Evaluation of the Efficacy of STRATAFIX for Neurosurgical Cranial and Spine Procedures
About This Trial
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.
Who May Be Eligible (Plain English)
Who May Qualify:
- Elective or emergent surgical approaches for cranial or spine neurosurgical approaches, requiring sutures for wound closure, requiring multilayer wound closure
Who Should NOT Join This Trial:
- Patients with prior surgical wound dehiscence or infection
- Patients with allergy to suture material
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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
Treatments Being Tested
DEVICE
STRATAFIX PDS and Monocryl suture
STRATAFIX, suture employs a novel incorporation of barbed components to suture resulting in tension holding closure with long-lasting absorbable suture.
Locations (1)
University of Michigan Health Sparrow
Lansing, Michigan, United States