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| Name | Class |
|---|---|
| Johnson & Johnson | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| STRATAFIX PDS and Monocryl suture | Experimental | All participants enrolled will have their scheduled surgery as planned with their wound closed using STRATAFIX. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| STRATAFIX PDS and Monocryl suture | Device | STRATAFIX, suture employs a novel incorporation of barbed components to suture resulting in tension holding closure with long-lasting absorbable suture. |
| Measure | Description | Time Frame |
|---|---|---|
| Wound complications Bates-Jensen Wound Assessment Tool (BWAT) score | 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. | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Wound complications Bates-Jensen Wound Assessment Tool (BWAT) score | 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Karen Sagher | Contact | 734-232-4843 | kfrisch@med.umich.edu |
| Name | Affiliation | Role |
|---|---|---|
| Michael Karsy, MD, PhD, MSc | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan Health Sparrow | Recruiting | Lansing | Michigan | 48912 | United States |
Unclear if manuscript will be published in an ICMJE journal and data from this study are restricted from the University of Michigan Data Use Committee
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| ID | Term |
|---|---|
| D000083302 | Hemorrhagic Stroke |
| D000070642 | Brain Injuries, Traumatic |
| D001932 | Brain Neoplasms |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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Open label, single-arm, non-crossover prospective cohort study with non-inferiority statistical analysis.
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| 3 and 6 months |
| The Wound-Quality of Life (QOL) questionnaire score | This is a 17-point scale with 5 choices each ranging from 17-85. Higher scores indicate worse quality of life. | 1, 3 and 6 months |
| Intraoperative time required for wound closure | Time for intraoperative wound closure will be monitored. Wound closure technique will be video recorded. | Immediately following surgery |
| Percent of participants positive for superficial surgical site infection (SSI) | Assessed using a culture or polymerase chain reaction | Up to six months |
| Number of case deviations and descriptions from prescribed suturing paradigm | A quantification and description for additional suture material required for surgical procedures will be monitored. | Immediately following surgery |
| Liker scale of patient satisfaction with wound | 10 point subjective scale indicating patient satisfaction with wound | 1, 3 and 6 months |
| Wound imaging at perioperative followup | Wound pictures during followup period. | 1, 3 and 6 months |
| Wound revision strategy | Description of any wound revision strategies and timing | up to 6 months |
| D009422 |
| Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001930 | Brain Injuries |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |