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

NCT05914311 | Completed FDA Device

• 1 other identifier: IRB00087042
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Chronic Pain

Keywords

Spinal Cord Stimulation (SCS); chronic pain; stimulator

Outcome Measures

Primary Outcomes (1)

• Migration rate of trial leads

  Migration rate of trial leads anchored with Dermabond and suture versus suture alone will be measured by 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 Outcomes (4)

• Patient Satisfaction Score

  Day 8

• Rate of Infection

  Day 8

• Difference in Lead Position - Prone Fluoroscopy vs Upright X-ray

  Day 8

• Number of Patients with Pain Relief

  Day 8

Study Arms (2)

Suture Group

ACTIVE COMPARATOR

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

Device: Suture

Dermabond

EXPERIMENTAL

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

Device: Suture; Device: Dermabond

Interventions

Suture DEVICE

secures SCS trial leads with a suture

Dermabond; Suture Group

Dermabond DEVICE

secures SCS trial leads with dermabond

Dermabond

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age greater than 18
• having a spinal cord stimulator trial lead placement done
• lead placement to be done in the thoracic spine area

You may not qualify if:

• dermabond allergy
• inability to place 2 leads in subject
• lead placement not in thoracic spine

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Chronic Pain

Interventions

Sutures

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Surgical Fixation Devices; Surgical Equipment; Equipment and Supplies

Study Officials

• Carlyle Hamsher, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2023
• First Posted: June 22, 2023
• Study Start: September 8, 2023
• Primary Completion: February 26, 2025
• Study Completion: February 26, 2025
• Last Updated: December 17, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)