NCT05914311

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 57 (actual)
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed 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

Conditions

• Chronic Pain

Interventions

Type	Name	Description
DEVICE	Suture	secures SCS trial leads with a suture
DEVICE	Dermabond	secures SCS trial leads with dermabond

Timeline

• Start date: 2023-09-08
• Primary completion: 2025-02-26
• Completion: 2025-02-26
• First posted: 2023-06-22
• Last updated: 2025-12-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study