Wound Closure TechniquesNCT02550574
Use of 2-octylcyanoacrylate With Full-thickness Skin Grafts
A study testing Wound Closure with 2-octylcyanoacrylate and Wound Closure with 5-0 Vicryl Sutures in people with Wound Closure Techniques, run by University of California, Davis.
Trial summary
The purpose of this study is to determine whether the use of 2-octylcyanoacrylate during repair of cutaneous surgery wounds with full-thickness skin grafts improves scar cosmesis compared to wound closure with sutures. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Wound Closure Techniques
- What is being tested?
- Wound Closure with 2-octylcyanoacrylate and Wound Closure with 5-0 Vicryl Sutures
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Aug 2015to May 2017
- 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
- Over 18 years of age
- Able to give informed consent themselves
- Patient scheduled for cutaneous surgical procedure with predicted closure with full-thickness skin graft
- Willing to return for follow-up visits
Who cannot join
- Mentally handicapped
- Unable to understand written and oral English
- Incarceration
- Under 18 years of age
- Pregnant Women
- Patients on systemic steroid therapies
- Patients with Marfans
- Patients with allergies to 2-octylcyanoacrylate
About this study
Official title: Use of 2-octylcyanoacrylate (Dermabond) During Cutaneous Wound Closure With Full-thickness Skin Grafts: a Randomized Split Wound Comparative Effectiveness Trial
The purpose of this study is to determine whether the use of 2-octylcyanoacrylate during repair of cutaneous surgery wounds with full-thickness skin grafts improves scar cosmesis compared to wound closure with sutures.
Read the detailed description
The purpose of this study is to determine whether the use of 2-octylcyanoacrylate during repair of cutaneous surgery wounds with full-thickness skin grafts improves scar cosmesis compared to wound closure with sutures. Our aims are to compare outcomes using a split wound model, where half of the wound is treated with 2-octylcyanoacrylate and the other half is repaired with sutures, per the standard of care. Three-months post-surgery, the scar will be measured via the physician observer scar assessment scale, a validated scar instrument. Our hypothesis is that 2-octylcyanoacrylate will result in cosmetically superior wound outcomes.
- Conditions
- Wound Closure Techniques
- Being tested
- Wound Closure with 2-octylcyanoacrylate, Wound Closure with 5-0 Vicryl Sutures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wound Closure with 2-octylcyanoacrylateProcedure or surgery
Wound Closure with 5-0 Vicryl SuturesProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Wound closure with 2-octylcyanoacrylate | Experimental | One side of the patient's wound defect will be assigned to wound closure with 2-octylcyanoacrylate liquid bonding agent). Receives: Procedure: Wound Closure with 2-octylcyanoacrylate; Procedure: Wound Closure with 5-0 Vicryl Sutures |
| Wound closure with 5-0 vicryl sutures | Active comparator | One side of the patient's wound defect will be assigned to wound closure with 5-0 vicryl sutures. Receives: Procedure: Wound Closure with 2-octylcyanoacrylate; Procedure: Wound Closure with 5-0 Vicryl Sutures |
What is being measured
The primary outcome is the main question the study is designed to answer.
Appearance of Scar on the Patient and Observer Scar Assessment Scale
After surgical procedure, half of the subject's wound will be with 2-octylcyanoacrylate, while the other half is closed 5-0 vicryl sutures. After 3 months, subjects will return to clinic for evaluation of the cosmesis of both types of closure techniques.
Measured: 3 months
Secondary outcomes (2)
Incidence of Graft Failure on Case Report
The secondary endpoint will include incidence of graft failure (partial and complete on both sides).
Measured: 3 months
Incidence of Complications on Case Report
Noting the presence or absence of bleeding, dehiscence, infection or spitting sutures.
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 posted15 Sep 2015 (estimated)
- Study startAug 2015
- Primary completionDec 2016
- Study completionMay 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wound Closure TechniquesStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Daniel Eisen, M.D., Principal investigator, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02550574
- Sponsor's protocol ID
- 773443
- Status last verified
- Dec 2016
- First submitted
- 9 Sep 2015
- Last updated
- 21 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of 2-octylcyanoacrylate (Dermabond) During Cutaneous Wound Closure With Full-thickness Skin Grafts: a Randomized Split Wound Comparative Effectiveness Trial
- ClinicalTrials.gov ID
- NCT02550574
- Acronym / sponsor ID
- 773443
- Conditions
- Wound Closure Techniques
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- Dec 2016 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 15 Sep 2015 (estimated)
- 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.
The purpose of this study is to determine whether the use of 2-octylcyanoacrylate during repair of cutaneous surgery wounds with full-thickness skin grafts improves scar cosmesis compared to wound closure with sutures.
Detailed description
The purpose of this study is to determine whether the use of 2-octylcyanoacrylate during repair of cutaneous surgery wounds with full-thickness skin grafts improves scar cosmesis compared to wound closure with sutures. Our aims are to compare outcomes using a split wound model, where half of the wound is treated with 2-octylcyanoacrylate and the other half is repaired with sutures, per the standard of care. Three-months post-surgery, the scar will be measured via the physician observer scar assessment scale, a validated scar instrument. Our hypothesis is that 2-octylcyanoacrylate will result in cosmetically superior wound outcomes.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Wound closure with 2-octylcyanoacrylate | Experimental | Procedure: Wound Closure with 2-octylcyanoacrylate, Procedure: Wound Closure with 5-0 Vicryl SuturesOne side of the patient's wound defect will be assigned to wound closure with 2-octylcyanoacrylate liquid bonding agent). |
| Wound closure with 5-0 vicryl sutures | Active comparator | Procedure: Wound Closure with 2-octylcyanoacrylate, Procedure: Wound Closure with 5-0 Vicryl SuturesOne side of the patient's wound defect will be assigned to wound closure with 5-0 vicryl sutures. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Over 18 years of age
- Able to give informed consent themselves
- Patient scheduled for cutaneous surgical procedure with predicted closure with full-thickness skin graft
- Willing to return for follow-up visits
Key exclusion criteria (8 listed)
- Mentally handicapped
- Unable to understand written and oral English
- Incarceration
- Under 18 years of age
- Pregnant Women
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 |
|---|---|---|
| Wound Closure with 2-octylcyanoacrylate | Procedure or surgery | Wound closure with 2-octylcyanoacrylate, Wound closure with 5-0 vicryl sutures |
| Wound Closure with 5-0 Vicryl Sutures | Procedure or surgery | Wound closure with 2-octylcyanoacrylate, Wound closure with 5-0 vicryl sutures |
Primary outcome
Appearance of Scar on the Patient and Observer Scar Assessment Scale
Time frame: 3 months
After surgical procedure, half of the subject's wound will be with 2-octylcyanoacrylate, while the other half is closed 5-0 vicryl sutures. After 3 months, subjects will return to clinic for evaluation of the cosmesis of both types of closure techniques.
2 secondary outcomes
Incidence of Graft Failure on Case Report
Time frame: 3 months
Incidence of Complications on Case Report
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 21 Jun 2017.
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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, M.D. principal investigator
University of California, Davis
Questions about this trial
What is this clinical trial studying?
A study testing Wound Closure with 2-octylcyanoacrylate and Wound Closure with 5-0 Vicryl Sutures in people with Wound Closure Techniques, run by University of California, Davis.
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 8 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 21 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Appearance of Scar on the Patient and Observer Scar Assessment Scale (time frame: 3 months). 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 21 Jun 2017; AzTrials last refreshed its copy on 8 Nov 2026.