Use of Dermabond in Mitigation of Spinal Cord Stimulation (SCS) Trial Lead Migration

Chronic Pain Clinical Trial

Official title:

Use of Dermabond in Mitigation of Spinal Cord Stimulation Trial Lead Migration

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05914311
• Other study ID #: IRB00087042
• Status: Recruiting
• Phase: N/A
• Start date: September 8, 2023
• Est. completion date: August 2025

Study information

• Verified date: February 2024
• Source: Wake Forest University Health Sciences
• Contact: Carlyle Hamsher, MD
• Phone: 336-716-4498
• Email: chamsher[@]wakehealth.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

Spinal Cord stimulator trials require precise placement of leads to get appropriate distribution of pain.1 Since the leads are not anchored into the tissue, migration of the leads can occur and result in suboptimal trial. Migration (or movement in the epidural space after placement) of the leads can result in up to 2.49 mm to 3.24 mm migration in the leads depending on trial length . During the 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 56
• Est. completion date: August 2025
• Est. primary completion date: August 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain

Intervention

Device:
• Suture
secures SCS trial leads with a suture
• Dermabond
secures SCS trial leads with dermabond

Locations

Country	Name	City	State
United States	Wake Forest University Health Sciences	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lead migration between groups	Change in trial lead position as measured in millimeters when comparing initial x-ray after placement versus x-ray taken at lead removal 5-8 days after placement	From Baseline through Day 8
Secondary	Patient satisfaction	Lower satisfaction in patients that had lead migration versus patients that did not. Satisfaction will be valued on a 0-10 scale, with 0- not satisfied at all up to 10- greatest level of satisfaction	Baseline, Day 8
Secondary	Affect of length of trial on migration	Determination to see if a longer trial predisposes SCS trial lead insertion site to a higher rate of migration within a 5-8 day period as determined by initial x-ray post procedure to end of SCS trial x-ray	Baseline, Day 8
Secondary	Prone fluoroscopy	Difference in lead position on prone (face down) fluoroscopy when comparing dermabond vs no dermabond at lead insertion site as determined by initial x-ray post procedure to end of SCS trial x-ray	Baseline, Day 8
Secondary	Number of patients who received pain relief from the SCS trial	Number of responders to the prognostic lead placements defined as >50% pain relief over the length of the trial.	Baseline, Day 8
Secondary	Upright x-ray	Difference in lead position on upright (standing) x-ray when comparing dermabond vs no dermabond at lead insertion site as determined by initial x-ray post procedure to end of SCS trial x-ray	Baseline, Day 8