Using Dermabond to prevent lead migration in spinal cord stimulation for chronic pain
Use of Dermabond in Mitigation of Spinal Cord Stimulation Trial Lead Migration
This study is testing whether using Dermabond instead of stitches or tape can better keep spinal cord stimulation leads in place for people with chronic pain.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 56 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Wake Forest University Health Sciences Academic / other |
| Locations | 1 site (Winston-Salem, North Carolina) |
| Trial ID | NCT05914311 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of Dermabond compared to traditional methods like sutures and tape in securing spinal cord stimulation (SCS) trial leads. During SCS trials, leads are placed outside the skin and can migrate, leading to ineffective pain management. The study will measure the amount of lead movement based on the securing method used during placement, focusing on leads placed in the thoracic spine. By comparing these methods, the study aims to determine the best approach to minimize lead migration.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 who are undergoing spinal cord stimulator trial lead placement in the thoracic spine.
Not a fit: Patients with a known allergy to Dermabond or those who cannot have two leads placed will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance the effectiveness of spinal cord stimulation for chronic pain management by reducing lead migration.
How similar studies have performed: While there is limited data on the specific use of Dermabond for this purpose, similar studies have explored lead stabilization techniques in spinal cord stimulation with varying degrees of success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * age greater than 18 * having a spinal cord stimulator trial lead placement done * lead placement to be done in the thoracic spine area Exclusion Criteria: * dermabond allergy * inability to place 2 leads in subject * lead placement not in thoracic spine
Where this trial is running
Winston-Salem, North Carolina
- Wake Forest University Health Sciences — Winston-Salem, North Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Carlyle Hamsher, MD — Wake Forest University Health Sciences
- Study coordinator: Carlyle Hamsher, MD
- Email: chamsher@wakehealth.edu
- Phone: 336-716-4498
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.