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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
160
STRATAFIX, suture employs a novel incorporation of barbed components to suture resulting in tension holding closure with long-lasting absorbable suture.
University of Michigan Health Sparrow
Lansing, Michigan, United States
RECRUITINGWound 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.
Time frame: 1 month
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)
Time frame: 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.
Time frame: 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.
Time frame: Immediately following surgery
Percent of participants positive for superficial surgical site infection (SSI)
Assessed using a culture or polymerase chain reaction
Time frame: 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.
Time frame: Immediately following surgery
Liker scale of patient satisfaction with wound
10 point subjective scale indicating patient satisfaction with wound
Time frame: 1, 3 and 6 months
Wound imaging at perioperative followup
Wound pictures during followup period.
Time frame: 1, 3 and 6 months
Wound revision strategy
Description of any wound revision strategies and timing
Time frame: up to 6 months
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