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

Wake Forest University (WFU)

Status: Completed

Conditions: Chronic Pain

Treatments: Device: Suture; Device: Dermabond

Study type: Interventional

Funder types: Other

Identifiers

NCT05914311

IRB00087042

Details and patient eligibility

About

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

Full 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

Enrollment: 57 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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57 participants in 2 patient groups

Suture Group

Active Comparator group

Description:

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

Treatment:

Device: Suture

Dermabond

Experimental group

Description:

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

Treatment:

Device: Dermabond

Device: Suture