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

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

Study Overview

• Status: Completed
• Conditions: Chronic Pain
• Intervention / Treatment: Device: Suture; Device: Suture and Dermabond

Detailed Description

Spinal Cord stimulator trials require precise placement of leads to get appropriate distribution of pain. 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

• Study Type: Interventional
• Enrollment (Actual): 57
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest University Health Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Suture Group; secure one of the 2 trial leads with suture only-randomized to left or right	Device: Suture; secures SCS trial leads with a suture
Experimental: Dermabond and Suture Group; secure one of the 2 trial leads to be secured with both dermabond and suture-randomized to left or right	Device: Suture; secures SCS trial leads with a suture; Device: Suture and Dermabond; secures SCS trial leads with dermabond and suture

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Migration Distance of Trial Leads	Migration distance 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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Satisfaction Score	Patient satisfaction score will be valued on a 0-10 scale, with 0-not satisfied at all up to 10-greatest level of satisfaction. The survey asked general questions about participant satisfaction with the spinal cord stimulator (SCS) trial experience (overall satisfaction with experience), not about participant satisfaction with the Dermabond or suture fixation interventions separately.	Day 8
Rate of Infection	percent of participants with a higher rate of infection	Day 8
Number of Patients With Pain Relief	Number of patients who received pain relief from the spinal cord stimulation trial. Number of responders to the prognostic lead placements defined as >50% pain relief over the length of the trial.	Day 8

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference in Lead Position - Prone Fluoroscopy vs Upright X-ray	Difference in lead position on prone (face down) fluoroscopy vs upright (standing) x-ray	Day 8

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Investigators: Principal Investigator: Carlyle Hamsher, MD, Wake Forest University Health Sciences

Study record dates

Study Major Dates

• Study Start (Actual): September 8, 2023
• Primary Completion (Actual): February 26, 2025
• Study Completion (Actual): February 26, 2025

Study Registration Dates

• First Submitted: June 13, 2023
• First Submitted That Met QC Criteria: June 13, 2023
• First Posted (Actual): June 22, 2023

Study Record Updates

• Last Update Posted (Actual): June 9, 2026
• Last Update Submitted That Met QC Criteria: May 12, 2026
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: chronic pain; Spinal Cord Stimulation (SCS); stimulator
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Chronic Pain; Surgical Equipment; Equipment and Supplies; Surgical Fixation Devices; Sutures
• Other Study ID Numbers: IRB00087042

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: analysis will include all participant data via publication

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes