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

Primary Purpose

Chronic Pain

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Suture

Dermabond

About this trial

This is an interventional prevention trial for Chronic Pain focused on measuring Spinal Cord Stimulation (SCS), chronic pain, stimulator

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Wake Forest University Health SciencesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Suture Group

Dermabond

Arm Description

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

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

Outcomes

Primary Outcome Measures

Lead migration between groups

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 Outcome Measures

Patient satisfaction

Lower satisfaction in patients that had lead migration versus patients that did not. Satisfaction will be valued on a 0-10 scale, with 0- not satisfied at all up to 10- greatest level of satisfaction

Affect of length of trial on migration

Determination to see if a longer trial predisposes SCS trial lead insertion site to a higher rate of migration within a 5-8 day period as determined by initial x-ray post procedure to end of SCS trial x-ray

Prone fluoroscopy

Difference in lead position on prone (face down) fluoroscopy when comparing dermabond vs no dermabond at lead insertion site as determined by initial x-ray post procedure to end of SCS trial x-ray

Number of patients who received pain relief from the SCS trial

Number of responders to the prognostic lead placements defined as >50% pain relief over the length of the trial.

Upright x-ray

Difference in lead position on upright (standing) x-ray when comparing dermabond vs no dermabond at lead insertion site as determined by initial x-ray post procedure to end of SCS trial x-ray

Full Information

NCT ID

NCT05914311

First Posted

June 13, 2023

Last Updated

September 28, 2023

Sponsor

Wake Forest University Health Sciences

1. Study Identification

Unique Protocol Identification Number

NCT05914311

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2023

Overall Recruitment Status

Recruiting

Study Start Date

September 8, 2023 (Actual)

Primary Completion Date

August 2024 (Anticipated)

Study Completion Date

August 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Wake Forest University Health Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Data Monitoring Committee

5. Study Description

Brief 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

Detailed 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Pain

Keywords

Spinal Cord Stimulation (SCS), chronic pain, stimulator

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

56 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Suture Group

Arm Type

Active Comparator

Arm Description

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

Arm Title

Dermabond

Arm Type

Experimental

Arm Description

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

Intervention Type

Device

Intervention Name(s)

Suture

Intervention Description

secures SCS trial leads with a suture

Intervention Type

Device

Intervention Name(s)

Dermabond

Intervention Description

secures SCS trial leads with dermabond

Primary Outcome Measure Information:

Title

Lead migration between groups

Description

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

Time Frame

From Baseline through Day 8

Secondary Outcome Measure Information:

Title

Patient satisfaction

Description

Lower satisfaction in patients that had lead migration versus patients that did not. Satisfaction will be valued on a 0-10 scale, with 0- not satisfied at all up to 10- greatest level of satisfaction

Time Frame

Baseline, Day 8

Title

Affect of length of trial on migration

Description

Time Frame

Baseline, Day 8

Title

Prone fluoroscopy

Description

Difference in lead position on prone (face down) fluoroscopy when comparing dermabond vs no dermabond at lead insertion site as determined by initial x-ray post procedure to end of SCS trial x-ray

Time Frame

Baseline, Day 8

Title

Number of patients who received pain relief from the SCS trial

Description

Number of responders to the prognostic lead placements defined as >50% pain relief over the length of the trial.

Time Frame

Baseline, Day 8

Title

Upright x-ray

Description

Difference in lead position on upright (standing) x-ray when comparing dermabond vs no dermabond at lead insertion site as determined by initial x-ray post procedure to end of SCS trial x-ray

Time Frame

Baseline, Day 8

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Carlyle Hamsher, MD

Phone

336-716-4498

chamsher@wakehealth.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Carlyle Hamsher, MD

Organizational Affiliation

Wake Forest University Health Sciences

Official's Role

Principal Investigator

Facility Information:

Facility Name

Wake Forest University Health Sciences

City

Winston-Salem

State/Province

North Carolina

ZIP/Postal Code

27157

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Carlyle Hamsher, MD

chamsher@wakehealth.edu

First Name & Middle Initial & Last Name & Degree

Carlyle Hamsher, MD

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

analysis will include all participant data via publication

Learn more about this trial

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

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