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Completed

NCT Number: NCT05914311

Use of Dermabond in Mitigation of Spinal Cord Stimulation (SCS) 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

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Suture

Device

secures SCS trial leads with a suture

Suture and Dermabond

Device

secures SCS trial leads with dermabond and suture

Primary outcomes

  1. Migration Distance of Trial Leads

    Time frame: From Baseline through Day 8

    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

Secondary outcomes

  1. Patient Satisfaction Score

    Time frame: Day 8

    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.

  2. Rate of Infection

    Time frame: Day 8

    percent of participants with a higher rate of infection

  3. Number of Patients With Pain Relief

    Time frame: Day 8

    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.

Other outcomes

  1. Difference in Lead Position - Prone Fluoroscopy vs Upright X-ray

    Time frame: Day 8

    Difference in lead position on prone (face down) fluoroscopy vs upright (standing) x-ray

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jun 22, 2023
Registry last updated
Jun 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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