Wound Closure TechniquesNCT02289859
Undermining During Cutaneous Wound Closure
A study testing Wound Closure with Undermining and Wound Closure without Undermining in people with Wound Closure Techniques, run by University of California, Davis.
Trial summary
The purpose of this study is to determine whether undermining during cutaneous surgery improves scar cosmesis compared to wound closure without undermining. 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 Undermining and Wound Closure without Undermining
- Type of treatment
- Injection or infusion, 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
- May 2014to Jul 2016
- 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
- Able to give informed consent themselves
- Patient scheduled for cutaneous surgical procedure with predicted linear closure
- Willing to return for follow up visits
Who cannot join
- Mentally handicapped
- Incarceration
- Pregnant Women
- Wounds with predicted closure length less than 3 cm
- Wounds with diameter > 3 cm
- Wounds unable to be fully closed without undermining
About this study
Official title: Undermining During Cutaneous Wound Closure: a Randomized Split Wound Comparative Effectiveness Trial
The purpose of this study is to determine whether undermining during cutaneous surgery improves scar cosmesis compared to wound closure without undermining.
Read the detailed description
The purpose of this study is to determine whether undermining during cutaneous surgery improves scar cosmesis compared to wound closure without undermining. Our aims are to compare outcomes using a split wound model, where half the wound is undermined and the other half is not. This will be measured via the physician observer scar assessment scale, a validated scar instrument and via wound width. Our hypothesis is that wound undermining will result in cosmetically superior wound outcomes.
- Conditions
- Wound Closure Techniques
- Being tested
- Wound Closure with Undermining, Wound Closure without Undermining
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wound Closure with UnderminingProcedure or surgery
The side assigned to undermining will have undermining performed prior to wound closure in the subcutaneous plane. The amount of undermining will range from 1 cm for wounds with low tension to 2 cm for those with moderate tension. Since wound diameter will be 3 cm or less and exclude the scalp, high tension wounds are not anticipated.
Wound Closure without UnderminingProcedure or surgery
One side of the wound will remain un-undermined.
| Study group | Role | What they receive |
|---|---|---|
| Wound Closure with Undermining | Active comparator | The side assigned to undermining will have undermining performed prior to wound closure in the subcutaneous plane. The amount of undermining will range from 1 cm for wounds with low tension to 2 cm for those with moderate tension. Since wound diameter will be 3 cm or less and exclude the scalp, high tension wounds are not anticipated. Receives: Procedure: Wound Closure with Undermining; Procedure: Wound Closure without Undermining |
| Wound Closure without Undermining | Active comparator | One side of the wound will remain un-undermined. Receives: Procedure: Wound Closure with Undermining; Procedure: Wound Closure without Undermining |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of Scar on the Patient and Observer Scar Assessment Scale
After surgical procedure, half of the subject's wound will be closed after undermining, while the other half is closed without undermining. 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)
Measurement of Scar Width
The width of the scar will be measured 1 centimeter from the midline on both sides. There is no defined width that is considered satisfactory or not satisfactory. The measurements will be compared between subjects.
Measured: 3 months
Assessment of Complications
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 posted13 Nov 2014 (estimated)
- Study startMay 2014
- Primary completionApr 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Wound Closure TechniquesStudies of the same condition, open and under way.
- 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 (actual)
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
- NCT02289859
- Sponsor's protocol ID
- 613430
- Status last verified
- Jul 2017
- First submitted
- 10 Nov 2014
- Last updated
- 18 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Joo J, Pourang A, Tchanque-Fossuo CN, Armstrong AW, Tartar DM, King TH, Sivamani RK, Eisen DB. Undermining during cutaneous wound closure for wounds less than 3 cm in diameter: a randomized split wound comparative effectiveness trial. Arch Dermatol Res. 2022 Sep;314(7):697-703. doi: 10.1007/s00403-021-02280-5. Epub 2021 Sep 21.
PubMed 34546436
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Undermining During Cutaneous Wound Closure: a Randomized Split Wound Comparative Effectiveness Trial
- ClinicalTrials.gov ID
- NCT02289859
- Acronym / sponsor ID
- 613430
- Conditions
- Wound Closure Techniques
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Study start
- May 2014 (actual)
- Primary completion
- Apr 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 13 Nov 2014 (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 undermining during cutaneous surgery improves scar cosmesis compared to wound closure without undermining.
Detailed description
The purpose of this study is to determine whether undermining during cutaneous surgery improves scar cosmesis compared to wound closure without undermining. Our aims are to compare outcomes using a split wound model, where half the wound is undermined and the other half is not. This will be measured via the physician observer scar assessment scale, a validated scar instrument and via wound width. Our hypothesis is that wound undermining 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 Undermining | Active comparator | Procedure: Wound Closure with Undermining, Procedure: Wound Closure without UnderminingThe side assigned to undermining will have undermining performed prior to wound closure in the subcutaneous plane. The amount of undermining will range from 1 cm for wounds with low tension to 2 cm for those with moderate tension. Since wound diameter will be 3 cm or less and exclude the scalp, high tension wounds are not anticipated. |
| Wound Closure without Undermining | Active comparator | Procedure: Wound Closure with Undermining, Procedure: Wound Closure without UnderminingOne side of the wound will remain un-undermined. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Able to give informed consent themselves
- Patient scheduled for cutaneous surgical procedure with predicted linear closure
- Willing to return for follow up visits
Key exclusion criteria (6 listed)
- Mentally handicapped
- Incarceration
- Pregnant Women
- Wounds with predicted closure length less than 3 cm
- Wounds with diameter > 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 |
|---|---|---|
| Wound Closure with UnderminingThe side assigned to undermining will have undermining performed prior to wound closure in the subcutaneous plane. The amount of undermining will range from 1 cm for wounds with low tension to 2 cm for those with moderate tension. Since wound diameter will be 3 cm or less and exclude the scalp, high tension wounds are not anticipated. | Procedure or surgery | Wound Closure with Undermining, Wound Closure without Undermining |
| Wound Closure without UnderminingOne side of the wound will remain un-undermined. | Procedure or surgery | Wound Closure with Undermining, Wound Closure without Undermining |
Primary outcome
Assessment 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 closed after undermining, while the other half is closed without undermining. After 3 months, subjects will return to clinic for evaluation of the cosmesis of both types of closure techniques.
2 secondary outcomes
Measurement of Scar Width
Time frame: 3 months
Assessment of Complications
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 18 Jul 2017.
- Derived from this study: PubMed 34546436Joo J, Pourang A, Tchanque-Fossuo CN, Armstrong AW, Tartar DM, King TH, Sivamani RK, Eisen DB. Undermining during cutaneous wound closure for wounds less than 3 cm in diameter: a randomized split wound comparative effectiveness trial. Arch Dermatol Res. 2022 Sep;314(7):697-703. doi: 10.1007/s00403-021-02280-5. Epub 2021 Sep 21.
- University of California-Davis Department of Dermatology Clinical ResearchLink provided by the sponsor.
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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 Undermining and Wound Closure without Undermining 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 3 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 18 Jul 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?
Assessment 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?
On the ClinicalTrials.gov record for NCT02289859, which also lists 1 linked publication.
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 18 Jul 2017.