ScarringNCT05449457
Aesthetic Outcome of Layered Closure vs. Layered Closure Followed by 2-Octyl Cyanoacrylate
A study testing 2-Octyl cyanoacrylate in people with Scarring, run by University of California, Davis at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Scarring
- What is being tested?
- 2-Octyl cyanoacrylate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Oct 2022to 9 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, Davis - Dermatology Department
Sacramento, California, 95816
About this study
Official title: Aesthetic Outcome of Layered Closure vs. Layered Closure Followed by 2-Octyl Cyanoacrylate: A Randomized Evaluator-Blinding Split-Wound Comparative Effectiveness Trial
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.
Read the 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
- Being tested
- 2-Octyl cyanoacrylate
- Medical subject headings
- Cicatrix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2-Octyl cyanoacrylateOther
Also called Dermabond
Involves closure supplemented by 2-octyl cyanoacrylate (3 layers)
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Other: 2-Octyl cyanoacrylate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 3 months
Secondary outcomes (1)
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2022
- Study start6 Oct 2022
- Primary completion9 Jun 2023
- Study completion9 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ScarringStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Daniel Eisen, MD, Principal investigator, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05449457
- Sponsor's protocol ID
- 1860725
- Status last verified
- Jun 2023
- First submitted
- 5 Jul 2022
- Last updated
- 14 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aesthetic Outcome of Layered Closure vs. Layered Closure Followed by 2-Octyl Cyanoacrylate: A Randomized Evaluator-Blinding Split-Wound Comparative Effectiveness Trial
- ClinicalTrials.gov ID
- NCT05449457
- Acronym / sponsor ID
- 1860725
- Conditions
- Scarring
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Study start
- 6 Oct 2022 (actual)
- Primary completion
- 9 Jun 2023 (actual)
- Study completion
- 9 Jun 2023 (actual)
- First posted
- 8 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: 2-Octyl cyanoacrylateOne 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- Incarceration
- Under 18 years of age
- Pregnant women
- Unable to understand written and oral English.
- Wounds with predicted closure length less than 3 cm
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 2-Octyl cyanoacrylateAlso: DermabondInvolves closure supplemented by 2-octyl cyanoacrylate (3 layers) | Other | Layered Closure with 2-Octyl Cyanoacrylate |
Primary outcome
Scar Assessment as measured by Patient Observer Scar Assessment Score (POSAS)
Time frame: 3 months
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
Time frame: 3 months
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.
1 secondary outcome
Complications or Adverse Events from Treatment
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel Eisen, MD principal investigator
University of California, Davis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 2-Octyl cyanoacrylate in people with Scarring, run by University of California, Davis at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Scar Assessment as measured by Patient Observer Scar Assessment Score (POSAS) (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2024.