Brain Tumor Adult, Hemorrhagic Stroke, Intracerebral, Neurovascular, Spine, Traumatic Brain Injury, Wound Closure
Conditions
Keywords
Superficial surgical site infection, Suture material, Wound closure techniques, brain tumor, spine, spine trauma, neurosurgery, hemorrhagic stroke, traumatic brain injury
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.
Interventions
DEVICESTRATAFIX 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.
Sponsors
Johnson & Johnson
University of Michigan
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Open label, single-arm, non-crossover prospective cohort study with non-inferiority statistical analysis.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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) |
| 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 |
| 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. |
Countries
United States
Contacts
Primary ContactKaren Sagher
Outcome results
None listed