Dermabond for Spinal Cord Stimulation Lead Security in Chronic Pain

Overseen By Carlyle Hamsher, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Wake Forest University Health Sciences

Disqualifiers: Dermabond allergy, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 5-8 days

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the effectiveness of two methods for securing spinal cord stimulator (SCS) leads in people with chronic pain. One method uses only sutures (stitches), while the other combines sutures with Dermabond, a type of medical glue. The trial aims to determine which method better prevents lead movement. Individuals receiving SCS lead placement in the thoracic spine (middle of the back) and without a Dermabond allergy may be suitable candidates for this trial. As an unphased trial, it offers participants the chance to contribute to innovative research that could enhance future treatment options for chronic pain.

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 prior data suggests that Dermabond is safe for securing spinal cord stimulation leads?

Research shows that Dermabond, a type of skin glue, often holds components in place during procedures like spinal cord stimulation. The FDA has approved it for various uses, indicating general safety. In studies on spinal cord procedures, Dermabond successfully secured leads without major safety concerns. Although infections can occur in spinal procedures, Dermabond itself hasn't been linked to significant safety issues. Overall, it appears well-tolerated for securing spinal leads. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the use of Dermabond in spinal cord stimulation for chronic pain because it offers a unique approach to securing leads. Unlike traditional methods that rely solely on sutures, Dermabond combines a medical adhesive with sutures, which could provide better stability and reduce lead migration. This combination may enhance the effectiveness of spinal cord stimulation by ensuring that the leads remain in place more securely, potentially improving patient outcomes and comfort.

What evidence suggests that Dermabond is effective for securing spinal cord stimulation leads in chronic pain?

In this trial, one treatment arm will use Dermabond, a type of medical glue, along with sutures to secure spinal cord stimulation (SCS) leads. Research shows that Dermabond effectively holds SCS leads in place by reducing their movement. Studies indicate that lead movement is a common issue in SCS trials and can affect pain relief. By keeping the leads stable, Dermabond might enhance treatment effectiveness by ensuring consistent pain relief. Additionally, Dermabond has successfully held tissues together and prevented infections in other medical procedures. These benefits suggest that Dermabond could improve the stability of SCS leads, potentially leading to better outcomes for people with chronic pain. ^{1 3 6 7 8}

Who Is on the Research Team?

Carlyle Hamsher, MD

Principal Investigator

Wake Forest University Health Sciences

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: Dermabond Experimental Treatment 2 Interventions

secure one of the 2 trial leads to be secured with both dermabond and suture-randomized to left or right

Group II: Suture Group Active Control 1 Intervention

secure one of the 2 trial leads with suture only-randomized to left or right

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials

1,432

Recruited

2,506,000+

Published Research Related to This Trial

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of tissue adhesive to secure spinal epidural stimulating electrodes: technical note. Simpson, RK., Halter, JA., Auzenne, DG.[2019]

The ESTIMET trial is a multicenter, randomized study comparing the efficacy of monocolumn versus multicolumn spinal cord stimulation (SCS) in patients with failed back surgery syndrome (FBSS) and significant back pain, involving 115 patients across 14 centers in France.

The primary goal is to assess whether multicolumn SCS can achieve a greater than 50% reduction in low back pain severity at 6 months, addressing a common limitation of traditional SCS in managing back pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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). Roulaud, M., Durand-Zaleski, I., Ingrand, P., et al.[2016]

A systematic analysis revealed that using a soft silastic anchor for spinal cord stimulation (SCS) leads significantly increases the time to failure by 65 times compared to unsupported leads, highlighting the importance of surgical technique in enhancing SCS reliability.

The study recommends specific surgical practices, such as a paramedian approach and proper anchoring techniques, to improve the longevity and effectiveness of SCS systems, which can help maintain their performance in treating neuropathic pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prevention of mechanical failures in implanted spinal cord stimulation systems. Henderson, JM., Schade, CM., Sasaki, J., et al.[2022]

In a study of 54 patients over 9.3 months, the 'midline anchoring' technique for a single Octrode® lead in spinal cord stimulation resulted in a low revision rate of only 4%, indicating high safety and effectiveness.

The technique achieved over 50% pain reduction in 85% of patients, with 89% experiencing successful coverage of lower extremity pain and 71% reporting adequate coverage of axial pain, suggesting it is a viable option for managing chronic pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Mironer, YE., Satterthwaite, JR., Lewis, EM., et al.[2022]

In a study of 172 patients with 305 implanted spinal cord stimulator leads over nearly 12 years, the overall fracture rate was found to be 4.3%.

Notably, the multilumen concentric (MLC) 8-contact leads showed no fractures during an average follow-up of 4.5 years, suggesting that this lead design may significantly reduce the risk of lead fractures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Long-Term Durability of Multilumen Concentric Percutaneous Spinal Cord Stimulator Leads. Simopoulos, T., Sharma, S., Aner, M., et al.[2019]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spinal cord stimulator--trial lead migration study. Osborne, MD., Ghazi, SM., Palmer, SC., et al.[2016]

In a study of 93 patients with failed back surgery syndrome, the use of percutaneous octapolar spinal cord stimulation (SCS) leads resulted in significant long-term pain relief, with average leg pain scores dropping from 72 to 32 after 12 months (P < 0.001).

The octapolar SCS leads also improved quality of life and sleep, with 63% of patients experiencing at least a 50% reduction in leg pain, indicating that advancements in SCS technology have led to better therapeutic outcomes compared to older 4-contact leads.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Gatzinsky, K., Baardsen, R., Buschman, HP.[2018]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A new technique of "midline anchoring" in spinal cord stimulation dramatically reduces lead migration. Mironer, YE., Brown, C., Satterthwaite, JR., et al.[2022]

In cases where epidural adhesions from previous spinal surgeries make it difficult to place a percutaneous electrode for spinal cord stimulation, a combination of open and percutaneous techniques can be effective.

This approach successfully allowed for adequate trial spinal cord stimulation using a single lead electrode, demonstrating a viable solution for patients with prior surgeries in the target stimulation area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The use of laminectomy for the placement of a percutaneous spinal cord stimulation electrode. Beems, T., Beekwilder, JP., van Dongen, RT.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11340739/

Epidural spread of surgical site infection from spinal cord ... A 38-year-old female with complex regional pain syndrome began an SCS trial, noting 100% pain relief for 5 days. Fluid drainage from the ...

2. withpower.com withpower.com/trial/phase-chronic-pain-5-2023-78e71

Dermabond for Spinal Cord Stimulation Lead Security ... What data supports the effectiveness of the treatment Dermabond for spinal cord stimulation lead security in chronic pain? The use of tissue adhesives, like ...

3. asra.com asra.com/news-publications/asra-newsletter/newsletter-item/asra-news/2020/08/01/surgical-considerations-for-spinal-cord-stimulation-implant

Surgical Considerations for Spinal Cord Stimulation Implant Spinal cord stimulation (SCS) is now an established therapy indicated for the treatment of chronic pain of the trunk and limbs.

4. ctv.veeva.com ctv.veeva.com/study/use-of-dermabond-in-mitigation-of-spinal-cord-stimulation-scs-trial-lead-migration

Use of Dermabond in Mitigation of Spinal Cord Stimulation ... 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 ...

5. neuromodulationjournal.org neuromodulationjournal.org/article/S1094-7159(21)06390-X/abstract

Recommendations for Surgical Technique for Spinal Cord ... 60. Cameron, T. Safety and efficacy of spinal cord stimulation for the treatment of chronic pain: a 20-year literature review.

6. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05914311/use-of-dermabond-in-mitigation-of-spinal-cord-stimulation-scs-trial-lead-migration

Use of Dermabond in Mitigation of Spinal Cord Stimulation ... 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 ...

7. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf3/P030017S357B.pdf

FDA - Summary of Safety and Effectiveness Data (SSED) Successful long-term outcomes of spinal cord stimulation despite limited pain relief during temporary trialing. Neuromodulation, 11(1):66-73. Petersen EA ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9290817/

Twelve‐Month results from multicenter, open‐label ... The purpose of this study was to compare the effectiveness of DTM SCS and traditional SCS in treating chronic LBP and leg pain (LP).