STRATAFIX for Wound Closure
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests the STRATAFIX suture, a type of stitch used to close surgical wounds, to assess its safety and effectiveness in cranial or spine surgeries. Although the FDA has already approved it, researchers aim to gather more data on the body's long-term reaction. Participants will have their surgical wounds closed with STRATAFIX to enhance understanding of its extended use. Individuals undergoing cranial or spine surgeries who require wound closure with stitches may be suitable candidates, provided they have no history of surgical wound healing issues or suture allergies. As a Phase 4 trial, this research highlights that STRATAFIX is already FDA-approved and effective, aiming to understand its benefits for more patients.
Do I have to stop taking my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What is the safety track record for the STRATAFIX suture?
Research has shown that the STRATAFIX suture is FDA-approved for closing surgical wounds, indicating its safety for that purpose. Studies have found that this suture provides a strong and secure closure, especially in areas under significant tension.
Although the safety of STRATAFIX for certain closures, such as those involving the abdominal wall, hasn't been fully confirmed, no strong evidence of major safety issues exists in its approved uses. The STRATAFIX suture is generally well-tolerated, with no unusual side effects reported in the available data.
Overall, based on current research and its FDA approval, the STRATAFIX suture appears safe for use in closing wounds.12345Why are researchers enthusiastic about this study treatment?
STRATAFIX is unique because it uses a barbed suture design for wound closure, which can potentially improve healing times and reduce complications compared to traditional smooth sutures. Unlike conventional sutures that require knots to secure, STRATAFIX features anchoring barbs that distribute tension evenly along the wound, promoting better tissue alignment and reducing the need for additional hardware or knot-tying. Researchers are excited about this treatment because it could simplify surgical procedures and enhance the overall healing process, offering a more efficient and reliable option for wound closure.
What is the effectiveness track record for STRATAFIX in wound closure?
Research has shown that STRATAFIX stitches effectively close surgical wounds. Studies have found these barbed stitches to be cost-effective and capable of speeding up wound closure. They have similar complication rates compared to regular stitches. STRATAFIX is particularly effective for wounds measuring 10-12 centimeters. Using STRATAFIX can reduce both wound closure time and overall surgery duration. The FDA has already approved this product for wound closure, supporting its proven effectiveness. Participants in this trial will have their scheduled surgery with wounds closed using STRATAFIX.36789
Who Is on the Research Team?
Michael Karsy, MD, PhD, MSc
Principal Investigator
University of Michigan
Are You a Good Fit for This Trial?
This trial is for individuals undergoing neurosurgical procedures for conditions like brain tumors, traumatic brain injury, or hemorrhagic stroke. It's focused on how they heal after using STRATAFIX sutures for wound closure.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo scheduled surgery with wound closure using STRATAFIX sutures
Follow-up
Participants are monitored for wound complications and quality of life over time
What Are the Treatments Tested in This Trial?
Interventions
- STRATAFIX
Trial Overview
The study tests the long-term safety and bodily reactions to FDA-approved STRATAFIX PDS and Monocryl sutures used in closing wounds post-neurosurgery.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
All participants enrolled will have their scheduled surgery as planned with their wound closed using STRATAFIX.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Michigan
Lead Sponsor
Johnson & Johnson
Industry Sponsor
Citations
Clinical Outcomes Among Patients Undergoing Open ...
Meta-analyses have found barbed sutures to be cost-effective, have shorter wound closure time, and similar complication rates as compared to ...
A Prospective Randomized Controlled Study of Stratafix ...
Stratafix is judged to be the most effective in a 10–12-cm sized surgical wound or its multiples. Overall, the barbed suture technique group ...
Evaluation of the Efficacy of STRATAFIX for Neurosurgical ...
This research is studying a device already approved by the Food and Drug Administration (FDA) to treat wound closures. Researchers are studying ...
A Prospective Randomized Controlled Study of Stratafix ...
Stratafix is judged to be the most effective in a 10–12-cm sized surgical wound or its multiples. Overall, the barbed suture technique group used 1.53 pieces, ...
A Comparison of Bidirectional Stratafix Continuous Suture ...
The employment of barbed sutures for wound closure has been reported to reduce both wound clo- sure time and overall operative time [1, 2].
K151200.pdf - accessdata.fda.gov
The STRATAFIX™ Spiral MONOCRYL™ Knotless Tissue Control Device, Variable Loop. Design consists of barbed suture material, armed with a surgical ...
STRATAFIX™ Spiral Knotless Tissue Control Devices
STRATAFIX™ Spiral - Ethicon's market leading barbed suture with antibacterial protection provides strong, secure closure appropriate for high-tension areas.
SXMP1B428-EMEA - Ethicon Surgical Technologies
The safety and effectiveness of the STRATAFIX¬ô Spiral MONOCRYL¬ô Plus Device have not been established for use in fascial closures (including abdominal wall, ...
Wound Closure Manual
The safety organizer tray is used for Coated VICRYL Sutures, MONOCRYL Sutures, PDS. II Sutures, ETHIBOND EXCEL Sutures, PERMA- HAND. Sutures, NUROLON Sutures ...
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