Basal Cell CarcinomaNCT01773447
Set-back Suture Versus Traditional Vertical Mattress Suture
A study testing Set-back suture and Vertical mattress suture 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 hope to compare two different methods of closing skin wounds using sutures. One of these methods (the set-back technique) was recently described in 2010 and has been reported to be technically easier and reduces the chance of spitting sutures (deep sutures that are pushed to the surface of the skin… 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?
- Set-back suture and Vertical mattress suture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2011to Apr 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
- Elliptical surgical wound that needs to be closed with a layered closure
- Wound 3 cm in length or longer
Who cannot join
- Incarceration
- Active pregnancy
- Less than 18 years of age
- Unable to give informed consent
- Non-English or Dutch speaking (the scar assessment scale described below has only been validated in the English and Dutch languages)
- Wound closure projected to be less than 3 cm in length
- Skin less than 3 mm in thickness (dermis and epidermis combined)
Trial locations and contacts
1 site in 1 country.
United States1 site
UC Davis, Department of Dermatology
Sacramento, California, 95816
About this study
Official title: Comparing Wound Eversion and Clinical Outcomes in Surgical Wound Repair With Subcuticular Set-back Versus Traditional Vertical Mattress Suturing Techniques
The investigators hope to compare two different methods of closing skin wounds using sutures. One of these methods (the set-back technique) was recently described in 2010 and has been reported to be technically easier and reduces the chance of spitting sutures (deep sutures that are pushed to the surface of the skin as the wound heals). The other method (the vertical mattress technique) has been used for many years with good results. However, no controlled studies have been performed to clearly demonstrate a difference between the two methods. We hope to find differences in the height of the wound edges immediately after surgery(5 minutes following the procedure) as well as the appearance of the scar and symptoms associated with the scar 3 months after surgery.
- Conditions
- Basal Cell Carcinoma, Squamous Cell Carcinoma, Melanoma
- Being tested
- Set-back suture, Vertical mattress suture
- 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.
Set-back sutureProcedure or surgery
Vertical mattress sutureProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Set-back suture | Active comparator | Wound to be close by set-back suture technique. Receives: Procedure: Set-back suture |
| Vertical mattress suture technique | Active comparator | Wound to be closed by vertical mattress technique. Receives: Procedure: Vertical mattress suture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean of sum of 2 blinded reviewers Physician Observer Assessment scores
Compare the functional and cosmetic outcomes of the two sutured halves of each scar at 3 months follow-up as follows:
- Use a previously validated scar assessment scale called the Patient and Observer Scar Assessment Scale, specifically the averaged sum of the total score of 2 blinded observers.
Measured: 3 months
Scar width
Width of scar in millimeters for each side of scar measured 1 cm from the midline.
Measured: 3 months
Secondary outcomes (1)
Height of scar immediately following wound closure
Height of each side of the wound will be measured 1 cm from the midpoint of the wound in millimeters
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2013 (estimated)
- Study startAug 2011
- Primary completionMar 2014
- Study completionApr 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
- Double blind
- Enrolment
- 47 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
- NCT01773447
- Sponsor's protocol ID
- 247354
- Status last verified
- Mar 2017
- First submitted
- 15 Jan 2013
- Last updated
- 31 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Wound Eversion and Clinical Outcomes in Surgical Wound Repair With Subcuticular Set-back Versus Traditional Vertical Mattress Suturing Techniques
- ClinicalTrials.gov ID
- NCT01773447
- Acronym / sponsor ID
- 247354
- Conditions
- Basal Cell Carcinoma, Squamous Cell Carcinoma, Melanoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (estimated)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Mar 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 23 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 hope to compare two different methods of closing skin wounds using sutures. One of these methods (the set-back technique) was recently described in 2010 and has been reported to be technically easier and reduces the chance of spitting sutures (deep sutures that are pushed to the surface of the skin as the wound heals). The other method (the vertical mattress technique) has been used for many years with good results. However, no controlled studies have been performed to clearly demonstrate a difference between the two methods. We hope to find differences in the height of the wound edges immediately after surgery(5 minutes following the procedure) as well as the appearance of the scar and symptoms associated with the scar 3 months after surgery.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Set-back suture | Active comparator | Procedure: Set-back sutureWound to be close by set-back suture technique. |
| Vertical mattress suture technique | Active comparator | Procedure: Vertical mattress sutureWound to be closed by vertical mattress technique. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Elliptical surgical wound that needs to be closed with a layered closure
- Wound 3 cm in length or longer
Key exclusion criteria (7 listed)
- Incarceration
- Active pregnancy
- Less than 18 years of age
- Unable to give informed consent
- Non-English or Dutch speaking (the scar assessment scale described below has only been validated in the English and Dutch languages)
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 |
|---|---|---|
| Set-back suture | Procedure or surgery | Set-back suture |
| Vertical mattress suture | Procedure or surgery | Vertical mattress suture technique |
Primary outcome
Mean of sum of 2 blinded reviewers Physician Observer Assessment scores
Time frame: 3 months
Compare the functional and cosmetic outcomes of the two sutured halves of each scar at 3 months follow-up as follows: a. Use a previously validated scar assessment scale called the Patient and Observer Scar Assessment Scale, specifically the averaged sum of the total score of 2 blinded observers.
Scar width
Time frame: 3 months
Width of scar in millimeters for each side of scar measured 1 cm from the midline.
1 secondary outcome
Height of scar immediately following wound closure
Time frame: 5 minutes
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 31 Mar 2017.
- 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 Set-back suture and Vertical mattress suture 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 2 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 31 Mar 2017. 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?
Mean of sum of 2 blinded reviewers Physician Observer Assessment scores (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 31 Mar 2017; AzTrials last refreshed its copy on 31 Oct 2026.