Recruiting

Dermabond vs. Mastisol, Grip-Lok

Sponsor:

University of Utah

Code:

NCT03976154

Conditions

Thoracic Epidural

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Thoracic Epidural Catheter Fixation Techniques

Study Details

Brief summary:

The purpose of our study is to assess the effectiveness of Dermabond as a thoracic epidural fixation technique compared to both Mastisol and the Grip-Lok fixation bandage, two common, widely used techniques for epidural fixation.

Conditions

Thoracic Epidural

Study ID

NCT03976154

Start date

Oct 1, 2019

Status verified date

Mar, 2025

Completion date

Dec 31, 2025

Anticipated

Primary completion date

Dec 31, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • surgical patient
  • receiving a thoracic epidural
  • 18 years of age or older

Exclusion Criteria:

  • Patient refusal
  • allergy to adhesives or local anesthesia
  • pregnancy
  • contraindication to receiving an epidural including coagulopathy, infection, elevated ICP, or severe pre-existing neurologic disorders

Study Design

Enrollment

300 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Dermabond

Catheter fixation will be performed after appropriate placement of a thoracic epidural with Dermabond. The investigator performing the thoracic epidural will distribute the Dermabond at the catheter insertion site in a space no greater than a 2 cm circle around the site. Once the Dermabond is allowed to dry, mastisol will be applied to the surrounding skin and a clear Tegaderm dressing will be used to cover the catheter. Catheter depth at the skin will be recorded at that time. An Epidural catheter infusion pump with 1/8thpercent Bupivacaine and 2mcg/ml Fentanyl will be attached to the catheter and started by the primary anesthesia with a goal rate of 6ml/hr.

active comparator: Mastisol

Catheter fixation will be performed after appropriate placement of a thoracic epidural with Mastisol spray. The investigator performing the epidural placement will distribute Mastisol spray both in close proximity to the catheter insertion site as well as around the insertion site. Once the Mastisol is allowed to dry, a clear Tegaderm dressing will be used to cover the catheter. Catheter depth at the skin will be recorded at that time. An Epidural catheter infusion pump with 1/8thpercent Bupivacaine and 2mcg/ml Fentanyl will be attached to the catheter and started by the primary anesthesia team with a goal rate of 6ml/hr.

active comparator: Grip-lock

Catheter fixation will be performed after appropriate placement of a thoracic epidural with a Grip-Lok fixation bandage. The investigator performing the epidural placement will place the fixation bandage one centimeter caudal from the insertion site. Mastisol will be applied to the surrounding skin and a clear Tegaderm will then be used to cover the catheter. Catheter depth at the skin will be recorded at that time. An Epidural catheter infusion pump with 1/8thpercent Bupivacaine and 2mcg/ml Fentanyl will be attached to the catheter and started by the primary anesthesia team in the operating room with a goal rate of 6ml/hr.

Interventions

Thoracic Epidural Catheter Fixation Techniques

All thoracic epidurals will be placed by a regional anesthesia resident or fellow under the direct supervision of an attending anesthesiologist using a standard epidural kit and in the paramedian approach.

Epidural placement will occur preoperatively in the same manner as our current practice criterion. There will be no difference in placement of the epidural catheter between the control groups and the treatment group. After placement, catheters will be secured with either Dermabond, Mastisol, or a Grip-Lok fixation bandage, all with overlying Tegaderms.

Primary outcome measure

  • Epidural catheter displacement immediately after surgery [ Time Frame: immediately after surgery in PACU ]
  • Epidural catheter displacement day 1 [ Time Frame: 24 hours post-operative ]
  • Epidural catheter displacement day 2 [ Time Frame: 48 hours post-operative ]
  • Epidural catheter displacement day 3 [ Time Frame: 72 hours post-operative ]
  • Epidural catheter displacement day 4 [ Time Frame: 96 hours post-operative ]
  • Epidural catheter displacement day 5 [ Time Frame: 120 hours post-operative ]
  • Epidural catheter displacement day 6 [ Time Frame: 144 hours post-operative ]
  • Epidural catheter displacement day 7 [ Time Frame: 168 hours post-operative ]

Central Contacts and Locations

Central contacts

Ami Stuart, PhD

8017934800ami.stuart@hsc.utah.edu

Adam Meier, DO

8015876393adam.meier@hsc.utah.edu

Locations

University of Utah Health Sciences Center

Recruiting

Salt Lake City, Utah, United States, 84132

Contacts

Julia L. White

801-587-4806julia.white@hsc.utah.edu

Principal Investigator:

Harriet W. Hopf, MD

More Information

Sponsor

University of Utah

Last update posted

Mar 7, 2025

Last verified

Mar, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Utah on 2025-03-07.