Study of STRATAFIX Sutures for Closing Neurosurgical Cranial and Spine Surgical Wounds to Assess Safety and Effectiveness

What this Trial Is About

Researchers are evaluating the safety and long-term effects of the STRATAFIX suture device, which is already approved by the FDA for wound closures. This study focuses on people undergoing neurosurgical procedures on the brain or spine and aims to gather more information on how the body reacts to the STRATAFIX suture over time and its safety in closing surgical wounds. All participants will have their planned neurosurgical cranial or spine surgery with their wounds closed using the STRATAFIX PDS and Monocryl suture. This device uses barbed components to hold wound tension and is designed to be a long-lasting absorbable suture. The study does not include a comparison group, and all enrolled participants will receive the STRATAFIX suture treatment during their surgery. Participants will be monitored for wound healing and complications at 1, 3, and 6 months after surgery using tools such as the Bates-Jensen Wound Assessment Tool and Wound-Quality of Life questionnaires. Researchers will also track surgical site infections, patient satisfaction, wound imaging, and any need for wound revision. The time taken to close wounds and adherence to the suturing method will be recorded immediately after surgery. The study may last up to six months post-surgery for each participant.

Evaluation of the Efficacy of STRATAFIX for Neurosurgical Cranial and Spine Procedures