Basal Cell CarcinomaNCT01770002
Eversion in Dermatologic Surgery: Is Cosmetic Appearance Improved?
A study testing Everted suture technique and Non-everted suture technique in people with Basal Cell Carcinoma and Squamous Cell Carcinoma, run by University of California, Davis at 1 site in United States.
Trial summary
The investigators hypothesize that everting wound edges while suturing surgical sites will result in more aesthetic scars. Additionally, we also hypothesize that small to moderate wound irregularities present at 3 months will resolve by 6 months after surgery with no intervention Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Basal Cell Carcinoma, Squamous Cell Carcinoma, Melanoma
- What is being tested?
- Everted suture technique and Non-everted suture technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2012to Sep 2014
- 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
- 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
- Unwilling to return for follow up
- Pregnant Women
- Wounds less than 3 cm in length
Trial locations and contacts
1 site in 1 country.
United States1 site
UC Davis, Department of Dermatology
Sacramento, California, 95816
About this study
The investigators hypothesize that everting wound edges while suturing surgical sites will result in more aesthetic scars. Additionally, we also hypothesize that small to moderate wound irregularities present at 3 months will resolve by 6 months after surgery with no intervention
- Conditions
- Basal Cell Carcinoma, Squamous Cell Carcinoma, Melanoma
- Being tested
- Everted suture technique, Non-everted suture technique
- Medical subject headings
- Carcinoma, Basal Cell, Carcinoma, Squamous Cell, Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Everted suture techniqueProcedure or surgery
Non-everted suture techniqueProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Everted suture technique | Active comparator | Technique that everts the skin; the edges will sit up against each other in a little peak, raised above the surrounding skin. Receives: Procedure: Everted suture technique |
| Non-everted suture technique | Active comparator | Surgical wound will be approximated such that the suture line is flat relative to the surrounding skin. Receives: Procedure: Non-everted suture technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Everted versus non-everted suturing techniques
Primary outcome measures for this study are the post operative scar width measured at 1 cm from the midline on both sides of the scar.
Measured: 3 and 6 months
Mean score of sum of 2 blinded observers POSAS scores
The mean summed total of two blinded reviewers Physician Observer Scar Assessment Scale (POSAS) scores for each side of the wound.
Measured: 3 and 6 months
Scar measurements (height, width, length)
Scar volume will be measured in centimeters on both sides of the wound
Measured: 3 and 6 months
Scar induration
Scar induration area will be measured in centimeters for both sides of the wound
Measured: 3 and 6 months
Scar erythema
Scar erythema area will be measured in centimeters for both sides of the wound
Measured: 3 and 6 months
Wound contour irregularities
Wound contour irregularities will be measured in terms of volume in cubic centimeters via a length, width and height measurement
Measured: 3 and 6 months
Stand cone volume
The volume of standing cones will be measured via length, width and height measurements in centimeters
Measured: 3 and 6 months
Uneven edge measurement
The area of uneven edges will be measured via a length x height measurement in centimeters
Measured: 3 and 6 months
Hyperpigmentation area
areas of hyperpigmentation will be measured via a length x width measurement in centimeters
Measured: 3 and 6 months
Secondary outcomes (3)
Infection
Infections occurring anytime during the study period will be recorded
Measured: up to 6 months
wound dehiscence
incidence of wound infection will be recorded anytime during the study period
Measured: up to 6 months
spitting sutures
spitting sutures will be counted for each side of the wound at 3 and 6 months
Measured: 3 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2013 (estimated)
- Study startJan 2012
- Primary completionSep 2013
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Basal Cell CarcinomaStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, 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, M.D., Principal investigator, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01770002
- Sponsor's protocol ID
- 265161
- Status last verified
- Apr 2015
- First submitted
- 15 Jan 2013
- Last updated
- 16 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Eversion in Dermatologic Surgery: Is Cosmetic Appearance Improved?
- ClinicalTrials.gov ID
- NCT01770002
- Acronym / sponsor ID
- 265161
- Conditions
- Basal Cell Carcinoma, Squamous Cell Carcinoma, Melanoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 17 Jan 2013 (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 investigators hypothesize that everting wound edges while suturing surgical sites will result in more aesthetic scars. Additionally, we also hypothesize that small to moderate wound irregularities present at 3 months will resolve by 6 months after surgery with no intervention
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Everted suture technique | Active comparator | Procedure: Everted suture techniqueTechnique that everts the skin; the edges will sit up against each other in a little peak, raised above the surrounding skin. |
| Non-everted suture technique | Active comparator | Procedure: Non-everted suture techniqueSurgical wound will be approximated such that the suture line is flat relative to the surrounding skin. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Over 18 years of age
- Able to give informed consent themselves
- Willing to return for follow up visits
Key exclusion criteria (7 listed)
- Mentally handicapped
- Unable to understand written and oral English
- Incarceration
- Under 18 years of age
- Unwilling to return for follow up
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 |
|---|---|---|
| Everted suture technique | Procedure or surgery | Everted suture technique |
| Non-everted suture technique | Procedure or surgery | Non-everted suture technique |
Primary outcome
Everted versus non-everted suturing techniques
Time frame: 3 and 6 months
Primary outcome measures for this study are the post operative scar width measured at 1 cm from the midline on both sides of the scar.
Mean score of sum of 2 blinded observers POSAS scores
Time frame: 3 and 6 months
The mean summed total of two blinded reviewers Physician Observer Scar Assessment Scale (POSAS) scores for each side of the wound.
Scar measurements (height, width, length)
Time frame: 3 and 6 months
Scar volume will be measured in centimeters on both sides of the wound
Scar induration
Time frame: 3 and 6 months
Scar induration area will be measured in centimeters for both sides of the wound
Scar erythema
Time frame: 3 and 6 months
Scar erythema area will be measured in centimeters for both sides of the wound
Wound contour irregularities
Time frame: 3 and 6 months
Wound contour irregularities will be measured in terms of volume in cubic centimeters via a length, width and height measurement
Stand cone volume
Time frame: 3 and 6 months
The volume of standing cones will be measured via length, width and height measurements in centimeters
Uneven edge measurement
Time frame: 3 and 6 months
The area of uneven edges will be measured via a length x height measurement in centimeters
Hyperpigmentation area
Time frame: 3 and 6 months
areas of hyperpigmentation will be measured via a length x width measurement in centimeters
3 secondary outcomes
Infection
Time frame: up to 6 months
wound dehiscence
Time frame: up to 6 months
spitting sutures
Time frame: 3 and 6 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 16 Apr 2015.
- 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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Everted suture technique and Non-everted suture technique in people with Basal Cell Carcinoma and Squamous Cell Carcinoma, 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 3 inclusion and 7 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 16 Apr 2015. 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?
Everted versus non-everted suturing techniques (time frame: 3 and 6 months). The study lists 9 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 16 Apr 2015.