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

Primary Purpose

Scarring

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
2-Octyl cyanoacrylate
Sponsored by
University of California, Davis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Scarring

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of California, Davis - Dermatology Department

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Layered Closure

Layered Closure with 2-Octyl Cyanoacrylate

Arm Description

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).

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).

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Complications or Adverse Events from Treatment
For example, if one half of the scar has more associated erythema, as measured using the Trace-to-Tape method, then it will be recorded. Other complications from the treatment will also be recorded.

Full Information

First Posted
July 5, 2022
Last Updated
June 15, 2023
Sponsor
University of California, Davis
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1. Study Identification

Unique Protocol Identification Number
NCT05449457
Brief Title
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

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 6, 2022 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Davis

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Scarring

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Outcomes Assessor
Masking Description
Two blinded observers will record their scores independently using the POSAS instrument.
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Layered Closure
Arm Type
No Intervention
Arm Description
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).
Arm Title
Layered Closure with 2-Octyl Cyanoacrylate
Arm Type
Experimental
Arm Description
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).
Intervention Type
Other
Intervention Name(s)
2-Octyl cyanoacrylate
Other Intervention Name(s)
Dermabond
Intervention Description
Involves closure supplemented by 2-octyl cyanoacrylate (3 layers)
Primary Outcome Measure Information:
Title
Scar Assessment as measured by Patient Observer Scar Assessment Score (POSAS)
Description
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.
Time Frame
3 months
Title
Width of Scar as measured using Trace-to-Tape Method
Description
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.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Complications or Adverse Events from Treatment
Description
For example, if one half of the scar has more associated erythema, as measured using the Trace-to-Tape method, then it will be recorded. Other complications from the treatment will also be recorded.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel Eisen, MD
Organizational Affiliation
University of California, Davis
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, Davis - Dermatology Department
City
Sacramento
State/Province
California
ZIP/Postal Code
95816
Country
United States

12. IPD Sharing Statement

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

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