Aesthetic Outcome of Layered Closure vs. Layered Closure Followed by 2-Octyl Cyanoacrylate

NCT05449457 | Completed

• 1 other identifier: 1860725
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Following skin surgeries on the head and neck, several surgeons use a type of surgical glue (such as Dermabond) as a final layer on the top of wound. This glue is thought to seal the wound. Up until this point, there is limited data about the exact advantages or disadvantages of using this glue. We wish to determine if there is a difference in the cosmetic outcome of the scar when the glue is applied compared to when the glue is not applied. In addition, we want to determine if patients prefer to care for a wound with or without the glue.

Conditions

Scarring

Outcome Measures

Primary Outcomes (2)

• Scar Assessment as measured by Patient Observer Scar Assessment Score (POSAS)

  The primary endpoint will be the score of two blinded reviewers independently using the POSAS assessment. The observer scale of the POSAS consists of six items (vascularity, pigmentation, thickness, relief, pliability, and surface area). All items are scored on a scale ranging from 1 ("like normal skin") to 10 ("worst scar imaginable"). The sum of the six items results in a total score of the POSAS observer scale. Furthermore, an overall opinion is scored on a scale ranging from 1 to 10. All parameters should preferably be compared to normal skin on a comparable anatomic location.

  3 months

• Width of Scar as measured using Trace-to-Tape Method

  The trace-to-tape method is an objective measure for linear postoperative scars. The mean scar width will be determined using the trace-to-tape method. The surface area of the scar will be collected by tracing the scar with a water-based gel pen. While still wet, the gel residue will be lifted from the skin with clear packing tape and transferred on a sheet of paper.

  3 months

Secondary Outcomes (1)

• Complications or Adverse Events from Treatment

  3 months

Study Arms (2)

Layered Closure

NO INTERVENTION

One half of the wound will have a cutaneous layer of sutures (2 layers), as is standard of care, while the other half of the wound will have an additional layer of 2-octyl cyanoacrylate (3 layers).

Layered Closure with 2-Octyl Cyanoacrylate

EXPERIMENTAL

One half of the wound will have a cutaneous layer of sutures (2 layers), as is standard of care, while the other half of the wound will have an additional layer of 2-octyl cyanoacrylate (3 layers).

Other: 2-Octyl cyanoacrylate

Interventions

2-Octyl cyanoacrylate OTHER

Involves closure supplemented by 2-octyl cyanoacrylate (3 layers)

Also known as: Dermabond

Layered Closure with 2-Octyl Cyanoacrylate

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or older
• Able to give informed consent themselves
• Patient scheduled for cutaneous surgical procedure on the face or neck with predicted primary closure.
• Willing to return for follow up visit

You may not qualify if:

• Incarceration
• Under 18 years of age
• Pregnant women
• Unable to understand written and oral English.
• Wounds with predicted closure length less than 3 cm
• None of these special populations will be included.

Sponsors & Collaborators

• University of California, Davis: lead

Study Sites (1)

University of California, Davis - Dermatology Department

Sacramento, California, 95816, United States

Location

MeSH Terms

Conditions

Cicatrix

Interventions

octyl 2-cyanoacrylate

Condition Hierarchy (Ancestors)

Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Daniel Eisen, MD

  University of California, Davis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Two blinded observers will record their scores independently using the POSAS instrument.
• Purpose: OTHER
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2022
• First Posted: July 8, 2022
• Study Start: October 6, 2022
• Primary Completion: June 9, 2023
• Study Completion: June 9, 2023
• Last Updated: June 14, 2024

Record last verified: 2023-06

Locations

US (1)