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

Not Applicable

Recruiting

• Conditions: Wound Closure; Brain Tumor Adult; Spine; Neurovascular; Hemorrhagic Stroke, Intracerebral; Traumatic Brain Injury

• Registration Number: NCT07225101
• Lead Sponsor: University of Michigan

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-11
• Study Start: 2025-11-01
• Study First Submitted: 2025-11-03
• Study First Submitted QC: 2025-11-03
• Last Update Submitted: 2025-11-03
• Study First Posted: 2025-11-05
• Last Update Posted: 2025-11-05
• Primary Completion: 2026-06-30
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 160

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Wound complications Bates-Jensen Wound Assessment Tool (BWAT) score	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 Outcome Measures

Name	Time	Method
Wound complications Bates-Jensen Wound Assessment Tool (BWAT) score	3 and 6 months	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)
The Wound-Quality of Life (QOL) questionnaire score	1, 3 and 6 months	This is a 17-point scale with 5 choices each ranging from 17-85. Higher scores indicate worse quality of life.
Intraoperative time required for wound closure	Immediately following surgery	Time for intraoperative wound closure will be monitored. Wound closure technique will be video recorded.
Percent of participants positive for superficial surgical site infection (SSI)	Up to six months	Assessed using a culture or polymerase chain reaction
Number of case deviations and descriptions from prescribed suturing paradigm	Immediately following surgery	A quantification and description for additional suture material required for surgical procedures will be monitored.
Liker scale of patient satisfaction with wound	1, 3 and 6 months	10 point subjective scale indicating patient satisfaction with wound
Wound imaging at perioperative followup	1, 3 and 6 months	Wound pictures during followup period.
Wound revision strategy	up to 6 months	Description of any wound revision strategies and timing

Trial Locations

Locations (1)

University of Michigan Health Sparrow; 🇺🇸 Lansing, Michigan, United States