Trial Outcomes & Findings for Use of Dermabond in Mitigation of Spinal Cord Stimulation (SCS) Trial Lead Migration (NCT NCT05914311)
NCT ID: NCT05914311
Last Updated: 2026-06-09
Results Overview
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
COMPLETED
NA
57 participants
From Baseline through Day 8
2026-06-09
Participant Flow
Unit of analysis: SCS Leads
Participant milestones
| Measure |
All Participants
Each participant will have one of the 2 trial leads secured with both dermabond and suture-randomized to left or right. This study will be a controlled trial of the two standard of care methods of securing SCS leads in which the trial leads (left and right) will be secured with one lead being secured with a suture only while the second lead will be secured after placement with both a suture in addition to Dermabond. The patient will serve as their own control.
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|---|---|
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Overall Study
STARTED
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57 2
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Overall Study
Suture Only
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57 1
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Overall Study
Suture and Dermabond
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57 1
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Overall Study
COMPLETED
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48 2
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Overall Study
NOT COMPLETED
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9 0
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Reasons for withdrawal
| Measure |
All Participants
Each participant will have one of the 2 trial leads secured with both dermabond and suture-randomized to left or right. This study will be a controlled trial of the two standard of care methods of securing SCS leads in which the trial leads (left and right) will be secured with one lead being secured with a suture only while the second lead will be secured after placement with both a suture in addition to Dermabond. The patient will serve as their own control.
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|---|---|
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Overall Study
procedure cancelled
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2
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Overall Study
missing images
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7
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Baseline Characteristics
Use of Dermabond in Mitigation of Spinal Cord Stimulation (SCS) Trial Lead Migration
Baseline characteristics by cohort
| Measure |
All Participants
n=57 Participants
Each participant will have one of the 2 trial leads secured with both dermabond and suture-randomized to left or right
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|---|---|
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Age, Continuous
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66.9 years
STANDARD_DEVIATION 12.8 • n=20 Participants
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Sex: Female, Male
Female
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28 Participants
n=20 Participants
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Sex: Female, Male
Male
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29 Participants
n=20 Participants
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Ethnicity (NIH/OMB)
Hispanic or Latino
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0 Participants
n=20 Participants
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
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56 Participants
n=20 Participants
|
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Ethnicity (NIH/OMB)
Unknown or Not Reported
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1 Participants
n=20 Participants
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=20 Participants
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Race (NIH/OMB)
Asian
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0 Participants
n=20 Participants
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Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=20 Participants
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Race (NIH/OMB)
Black or African American
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1 Participants
n=20 Participants
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Race (NIH/OMB)
White
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56 Participants
n=20 Participants
|
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Race (NIH/OMB)
More than one race
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0 Participants
n=20 Participants
|
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Race (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=20 Participants
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PRIMARY outcome
Timeframe: From Baseline through Day 8Migration 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
Outcome measures
| Measure |
Suture Group
n=48 Participants
secure one of the 2 trial leads with suture only-randomized to left or right
Suture: secures SCS trial leads with a suture
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Dermabond
n=48 Participants
secure one of the 2 trial leads to be secured with both dermabond and suture-randomized to left or right
Suture: secures SCS trial leads with a suture
Dermabond: secures SCS trial leads with dermabond
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|---|---|---|
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Migration Distance of Trial Leads
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10.6 mm
Standard Deviation 18.2
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9.1 mm
Standard Deviation 18.2
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SECONDARY outcome
Timeframe: Day 8Population: 3 participants did not complete their survey. Each participant received one lead secured with suture only and a second lead secured with both suture and Dermabond. The patient served as their own control.
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.
Outcome measures
| Measure |
Suture Group
n=45 Participants
secure one of the 2 trial leads with suture only-randomized to left or right
Suture: 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
Suture: secures SCS trial leads with a suture
Dermabond: secures SCS trial leads with dermabond
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|---|---|---|
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Patient Satisfaction Score
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7.386 score on a scale
Standard Deviation 2.058
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—
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SECONDARY outcome
Timeframe: Day 8percent of participants with a higher rate of infection
Outcome measures
| Measure |
Suture Group
n=48 Participants
secure one of the 2 trial leads with suture only-randomized to left or right
Suture: secures SCS trial leads with a suture
|
Dermabond
n=48 Participants
secure one of the 2 trial leads to be secured with both dermabond and suture-randomized to left or right
Suture: secures SCS trial leads with a suture
Dermabond: secures SCS trial leads with dermabond
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|---|---|---|
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Rate of Infection
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0 percent of participants
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0 percent of participants
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SECONDARY outcome
Timeframe: Day 8Number 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.
Outcome measures
| Measure |
Suture Group
n=48 Participants
secure one of the 2 trial leads with suture only-randomized to left or right
Suture: secures SCS trial leads with a suture
|
Dermabond
n=48 Participants
secure one of the 2 trial leads to be secured with both dermabond and suture-randomized to left or right
Suture: secures SCS trial leads with a suture
Dermabond: secures SCS trial leads with dermabond
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|---|---|---|
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Number of Patients With Pain Relief
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48 participants
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48 participants
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OTHER_PRE_SPECIFIED outcome
Timeframe: Day 8Difference in lead position on prone (face down) fluoroscopy vs upright (standing) x-ray
Outcome measures
Outcome data not reported
Adverse Events
All Participants
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place