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.
Elective or emergent surgical approaches for cranial or spine neurosurgical approaches, requiring sutures for wound closure, requiring multilayer wound closure
Patients with prior surgical wound dehiscence or infection
Patients with allergy to suture material
Single group
STRATAFIX PDS and Monocryl suture
DeviceSTRATAFIX, suture employs a novel incorporation of barbed components to suture resulting in tension holding closure with long-lasting absorbable suture.
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.
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)
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.
Intraoperative time required for wound closure
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)
Assessed using a culture or polymerase chain reaction
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University of Michigan
Lead sponsor
Johnson & Johnson
Collaborator
