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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, day 8

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

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My medical procedure involves placing a device in my upper back.

Select...

I am older than 18 years.

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I have had a trial lead placement for a spinal cord stimulator.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, day 8

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Lead migration between groups

Secondary outcome measures

Affect of length of trial on migration

Number of patients who received pain relief from the SCS trial

Patient satisfaction

+2 more

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

Suture

2010

Completed Phase 4

~2120

Dermabond

2016

N/A

~920

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Wake Forest University Health SciencesLead Sponsor

1,243 Previous Clinical Trials

1,004,670 Total Patients Enrolled

13 Trials studying Chronic Pain

702 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has this research endeavor begun the process of enlisting participants?

"According to information found on clinicaltrials.gov, this specific trial is not currently enrolling patients and has not been updated since June 13th 2023. However, 411 other trials are actively searching for participants at the moment."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2023. "Use of Dermabond in Mitigation of Spinal Cord Stimulation (SCS) Trial Lead Migration". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05914311.

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