Evaluation of the Efficacy of STRATAFIX for Neurosurgical Cranial and Spine Procedures
Trial Snapshot
- Phase
- Phase 4
- Status
- Recruiting
- Sponsor
- University of Michigan
- Enrollment
- 160
- Locations
- 1
- Primary Endpoint
- Wound complications Bates-Jensen Wound Assessment Tool (BWAT) score
Study Overview
Brief 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. This research will provide additional information about using STRATAFIX sutures to close surgical wounds.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
STRATAFIX PDS and Monocryl suture
All participants enrolled will have their scheduled surgery as planned with their wound closed using STRATAFIX.
Intervention: STRATAFIX PDS and Monocryl suture (Device)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Wound imaging at perioperative followup(1, 3 and 6 months)
- Wound revision strategy(up to 6 months)
- Wound complications Bates-Jensen Wound Assessment Tool (BWAT) score(3 and 6 months)
- The Wound-Quality of Life (QOL) questionnaire score(1, 3 and 6 months)
- Intraoperative time required for wound closure(Immediately following surgery)
- Percent of participants positive for superficial surgical site infection (SSI)(Up to six months)
- Number of case deviations and descriptions from prescribed suturing paradigm(Immediately following surgery)
- Liker scale of patient satisfaction with wound(1, 3 and 6 months)
Investigators
Michael Karsy
Assistant Clinical Professor of Neurosurgery
University of Michigan