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

NCT ID: NCT05914311

Last Updated: 2025-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

57 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-08

Study Completion Date

2025-02-26

Brief Summary

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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

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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

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Chronic Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Suture Group

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

Group Type ACTIVE_COMPARATOR

Suture

Intervention Type DEVICE

secures SCS trial leads with a suture

Dermabond

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

Group Type EXPERIMENTAL

Dermabond

Intervention Type DEVICE

secures SCS trial leads with dermabond

Suture

Intervention Type DEVICE

secures SCS trial leads with a suture

Interventions

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Dermabond

secures SCS trial leads with dermabond

Intervention Type DEVICE

Suture

secures SCS trial leads with a suture

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Wake Forest University Health Sciences

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Carlyle Hamsher, MD

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Locations

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Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Informed Consent Form

View Document

Other Identifiers

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IRB00087042

Identifier Type: -

Identifier Source: org_study_id