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

NCT ID: NCT05449457

Last Updated: 2024-06-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-06
• Study Completion Date: 2023-06-09

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.

Conditions

Scarring

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Layered Closure

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).

Group Type: NO_INTERVENTION

No interventions assigned to this group

Layered Closure with 2-Octyl Cyanoacrylate

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).

Group Type: EXPERIMENTAL

2-Octyl cyanoacrylate

Intervention Type: OTHER

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

Interventions

2-Octyl cyanoacrylate

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

Intervention Type: OTHER

Other Intervention Names

Dermabond

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of California, Davis

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Daniel Eisen, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, Davis

Locations

University of California, Davis - Dermatology Department

Sacramento, California, United States

Countries

United States

Other Identifiers

1860725

Identifier Type: -

Identifier Source: org_study_id