56 Participants Needed

Dermabond for Spinal Cord Stimulation Lead Security in Chronic Pain

CH
Overseen ByCarlyle Hamsher, MD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Wake Forest University Health Sciences
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 2 JurisdictionsThis treatment is already approved in other countries

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Dermabond for spinal cord stimulation lead security in chronic pain?

The use of tissue adhesives, like fibrin glue, has been shown to effectively prevent electrode migration in spinal cord stimulation, as demonstrated in a study where no migration occurred over a two-year follow-up. This suggests that similar adhesives, such as Dermabond, could also be effective in securing spinal cord stimulation leads.12345

How does the treatment Dermabond for Spinal Cord Stimulation Lead Security differ from other treatments for chronic pain?

Dermabond is unique because it is used to secure spinal cord stimulation leads, potentially reducing lead migration, which is a common issue with spinal cord stimulation treatments. This approach focuses on improving the stability and effectiveness of the spinal cord stimulation system, which is different from other treatments that may not address lead security.16789

What is the purpose of this trial?

During the typical SCS trial the leads remain outside of the skin and can be prone to migration. The leads are typically secured in place with suture, tape, or a combination of both. This study will evaluate the amount of movement based on the method of being secured at the time of placement

Research Team

CH

Carlyle Hamsher, MD

Principal Investigator

Wake Forest University Health Sciences

Eligibility Criteria

This trial is for adults over 18 with chronic pain who are undergoing a spinal cord stimulator (SCS) trial lead placement in the thoracic spine area. It's not suitable for those allergic to Dermabond or if two leads can't be placed.

Inclusion Criteria

My medical procedure involves placing a device in my upper back.
I am older than 18 years.
I have had a trial lead placement for a spinal cord stimulator.

Exclusion Criteria

You are allergic to Dermabond.
You cannot have two leads placed on you.
My medical device is not placed in my chest spine area.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Leads are placed and secured with either suture or dermabond and suture, and lead migration is monitored

5-8 days
Initial placement and removal visits (in-person)

Follow-up

Participants are monitored for lead migration and patient satisfaction after lead removal

1-2 weeks

Treatment Details

Interventions

  • Dermabond
Trial Overview The study is testing whether securing SCS trial leads with Dermabond, compared to sutures or tape, affects how much the leads move after they're put in place during a typical SCS procedure.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: DermabondExperimental Treatment2 Interventions
secure one of the 2 trial leads to be secured with both dermabond and suture-randomized to left or right
Group II: Suture GroupActive Control1 Intervention
secure one of the 2 trial leads with suture only-randomized to left or right

Find a Clinic Near You

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials
1,432
Recruited
2,506,000+

Findings from Research

In a study involving 20 patients, percutaneous spinal cord stimulator (SCS) leads were found to migrate significantly during a 3-day trial, with an average movement of 8.72 mm for leads anchored with tape only and 24.49 mm for those anchored with suture and tape.
The study revealed that using a suture and tape anchoring method resulted in significantly greater lead migration compared to using tape alone, indicating that the choice of anchoring method can impact lead stability during the trial period.
Spinal cord stimulator--trial lead migration study.Osborne, MD., Ghazi, SM., Palmer, SC., et al.[2016]
In a study involving four patients, the use of fibrin glue as a tissue adhesive successfully secured spinal cord stimulating electrodes in the epidural space without any migration over a two-year follow-up period.
This method provides a promising alternative to traditional suturing techniques, which can lead to complications like cerebrospinal fluid leaks and electrode migration.
Use of tissue adhesive to secure spinal epidural stimulating electrodes: technical note.Simpson, RK., Halter, JA., Auzenne, DG.[2019]
A new technique called 'midline anchoring' for spinal cord stimulation (SCS) lead placement significantly reduced lead migration rates from 23% to 6% after trial insertion and from 24% to 7% after implantation, based on a retrospective study of 122 trials and 91 implants over five years.
This method effectively addresses a common complication of SCS therapy, suggesting that midline anchoring could enhance the safety and efficacy of chronic pain treatment with spinal cord stimulation.
A new technique of "midline anchoring" in spinal cord stimulation dramatically reduces lead migration.Mironer, YE., Brown, C., Satterthwaite, JR., et al.[2022]

References

Spinal cord stimulator--trial lead migration study. [2016]
Use of tissue adhesive to secure spinal epidural stimulating electrodes: technical note. [2019]
A new technique of "midline anchoring" in spinal cord stimulation dramatically reduces lead migration. [2022]
Multicolumn spinal cord stimulation for significant low back pain in failed back surgery syndrome: design of a national, multicentre, randomized, controlled health economics trial (ESTIMET Study). [2016]
The use of laminectomy for the placement of a percutaneous spinal cord stimulation electrode. [2022]
Efficacy of a Single, Percutaneous, Across Midline, Octrode® Lead Using a "Midline Anchoring" Technique in the Treatment of Chronic Low Back and/or Lower Extremity Pain: A Retrospective Study. [2022]
The Long-Term Durability of Multilumen Concentric Percutaneous Spinal Cord Stimulator Leads. [2019]
Evaluation of the Effectiveness of Percutaneous Octapolar Leads in Pain Treatment with Spinal Cord Stimulation of Patients with Failed Back Surgery Syndrome During a 1-Year Follow-Up: A Prospective Multicenter International Study. [2018]
Prevention of mechanical failures in implanted spinal cord stimulation systems. [2022]
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