STRATAFIX for Wound Closure

Overseen By Karen Sagher

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: University of Michigan

Disqualifiers: Prior wound dehiscence, Suture allergy

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: Immediately following surgery

160 Participants Needed

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. ^{1 2 3 4 5}

Why 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. ^{3 6 7 8 9}

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

I had brain or spine surgery needing stitches for deep cuts.

Exclusion Criteria

Patients with allergy to suture material

I have had a surgical wound that reopened or got infected.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo scheduled surgery with wound closure using STRATAFIX sutures

Immediately following surgery

Follow-up

Participants are monitored for wound complications and quality of life over time

6 months

Visits at 1, 3, and 6 months

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?

Group I: STRATAFIX PDS and Monocryl suture Experimental Treatment 1 Intervention

All participants enrolled will have their scheduled surgery as planned with their wound closed using STRATAFIX.

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials

1,891

Recruited

6,458,000+

Johnson & Johnson

Industry Sponsor

Trials

116

Recruited

167,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11894428/

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 ...

2. ecios.org ecios.org/DOIx.php?id=10.4055/cios22017

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 ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT07225101?rank=6

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 ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11444938/

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, ...

5. wjon.elmerpub.com wjon.elmerpub.com/wjon/article/download/2642/219

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].

6. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf15/K151200.pdf

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 ...

7. jnjmedtech.com jnjmedtech.com/en-US/product/stratafix-spiral-knotless-tissue-control-device

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.

8. ethicon.com ethicon.com/emea/epc/code/sxmp1b428

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, ...

9. epiq-ah.com epiq-ah.com/wp-content/uploads/2025/01/Wound-Closure-Manual.pdf

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 ...