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Dermabond for Spinal Cord Stimulation Lead Security in Chronic Pain

N/A
Recruiting
Led By Carlyle Hamsher, MD
Research Sponsored by Wake Forest University Health Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Lead placement to be done in the thoracic spine area
Age greater than 18
Must not have
Lead placement not in thoracic spine
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, day 8
Awards & highlights
No Placebo-Only Group

Summary

This trial will look at how well leads are secured in place, and how much movement occurs, depending on the method used.

Who is the study for?
This trial is for adults over 18 with chronic pain who are undergoing a spinal cord stimulator (SCS) trial lead placement in the thoracic spine area. It's not suitable for those allergic to Dermabond or if two leads can't be placed.
What is being tested?
The study is testing whether securing SCS trial leads with Dermabond, compared to sutures or tape, affects how much the leads move after they're put in place during a typical SCS procedure.
What are the potential side effects?
Potential side effects may include skin irritation at the application site of Dermabond or suture materials and possible infection risks associated with any surgical adhesive used on skin.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My medical procedure involves placing a device in my upper back.
Select...
I am older than 18 years.
Select...
I have had a trial lead placement for a spinal cord stimulator.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
My medical device is not placed in my chest spine area.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, day 8
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, day 8 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Lead migration between groups
Secondary study objectives
Affect of length of trial on migration
Number of patients who received pain relief from the SCS trial
Patient satisfaction
+2 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: DermabondExperimental Treatment2 Interventions
secure one of the 2 trial leads to be secured with both dermabond and suture-randomized to left or right
Group II: Suture GroupActive Control1 Intervention
secure one of the 2 trial leads with suture only-randomized to left or right
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dermabond
2016
N/A
~930
Suture
2023
Completed Phase 4
~2160

Find a Location

Who is running the clinical trial?

Wake Forest University Health SciencesLead Sponsor
1,395 Previous Clinical Trials
2,460,149 Total Patients Enrolled
15 Trials studying Chronic Pain
1,086 Patients Enrolled for Chronic Pain
Carlyle Hamsher, MDPrincipal InvestigatorWake Forest University Health Sciences

Media Library

Dermabond Clinical Trial Eligibility Overview. Trial Name: NCT05914311 — N/A
Chronic Pain Research Study Groups: Suture Group, Dermabond
Chronic Pain Clinical Trial 2023: Dermabond Highlights & Side Effects. Trial Name: NCT05914311 — N/A
Dermabond 2023 Treatment Timeline for Medical Study. Trial Name: NCT05914311 — N/A
~20 spots leftby Aug 2025
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