Clinical trial NCT05449457: Aesthetic Outcome of Layered Closure vs. Layered Closure Followed by 2-Octyl Cyanoacrylate
Official title: Aesthetic Outcome of Layered Closure vs. Layered Closure Followed by 2-Octyl Cyanoacrylate: A Randomized Evaluator-Blinding Split-Wound Comparative Effectiveness Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Scarring
Lead sponsor: University of California, Davis
Sponsor class: OTHER
First posted: 2022-07-08
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: OTHER

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.

Detailed description: Sutures are the standard of care in repairing cutaneous wounds. The majority of surgical reconstructions following a Mohs micrographic surgery and standard surgical excisions require two layers of sutures: a deep (subcutaneous) layer and a superficial (cuticular) layer.

Alternatively, skin adhesives, such as 2-octyl cyanoacrylate (commercially available as "Dermabond"), have been used successfully in lieu of the outer layer of sutures. Cosmetic outcomes with 2-octyl cyanoacrylate have been shown to be equivalent to sutured wounds, perhaps with a lower infection rate. However, wounds repaired with 2-octyl cyanoacrylate may have a higher dehiscence rate.

Recently, surgeons have been using 2-octyl cyanoacrylate, in addition to dissolvable sutures. This is thought to combine the advantages of 2-octyl cyanoacrylate, including easier wound care and lower infection rate, with the lower dehiscence rate of sutures.

A previous study by Zhuang et al found no difference in wound cosmesis between deep sutures supplemented by 2-octyl cyanoacrylate compared with layered closure with 5-0 fast-absorbing gut suture, with the exception of inferior scar pigmentation with 2-octyl cyanoacrylate.1 Several studies likewise found no significant differences between 2-octyl cyanoacrylate versus sutures in repairing cutaneous wounds.

To our knowledge, no study has been conducted directly comparing closure (2 layers) versus closure supplemented by 2-octyl cyanoacrylate (3 layers). We hope that our study will provide new insight into this aspect of cutaneous surgery.

Eligibility criteria: All patients scheduled for cutaneous surgical procedures with one of the study investigators at the UC Davis Dermatology Clinic will be screened for eligibility.

Inclusion Criteria:

* 18 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Scar Assessment as measured by Patient Observer Scar Assessment Score (POSAS)
timeFrame: 3 months
measure: Width of Scar as measured using Trace-to-Tape Method
timeFrame: 3 months
Secondary outcomes:
measure: Complications or Adverse Events from Treatment
timeFrame: 3 months
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: University of California, Davis - Dermatology Department
state: California
Study officials:
affiliation: University of California, Davis
name: Daniel Eisen, MD
role: PRINCIPAL_INVESTIGATOR
References: