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

Last updated: January 27, 2025
Sponsor: Wake Forest University Health Sciences
Overall Status: Active - Recruiting

Phase

N/A

Condition

Chronic Pain

Pain

Treatment

Dermabond

Suture

Clinical Study ID

NCT05914311
IRB00087042
  • Ages > 18
  • All Genders

Study 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

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  • dermabond allergy

  • inability to place 2 leads in subject

  • lead placement not in thoracic spine

Study Design

Total Participants: 56
Treatment Group(s): 2
Primary Treatment: Dermabond
Phase:
Study Start date:
September 08, 2023
Estimated Completion Date:
August 31, 2025

Study 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

Connect with a study center

  • Wake Forest University Health Sciences

    Winston-Salem, North Carolina 27157
    United States

    Active - Recruiting

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