Subjects Undergoing Surgical Procedure of the SkinNCT01979497
Adhesive Strips in Dermatologic Surgery: Is Cosmetic Appearance Improved?
A study testing Suture with Adhesive Stripping and Suture without Adhesive Stripping in people with Subjects Undergoing Surgical Procedure of the Skin, run by University of California, Davis at 1 site in United States.
Trial summary
To determine whether the addition of adhesive stripping to a wound closed with dermal sutures improves outcome of wound closure. We hypothesize that the combination of adhesive strips to a wound closed with dermal sutures does not add significant cosmetic improvement of the resultant scar. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Subjects Undergoing Surgical Procedure of the Skin
- What is being tested?
- Suture with Adhesive Stripping and Suture without Adhesive Stripping
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2013to Jun 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
- 18 years of age or older
- Able to give informed consent themselves
- Willing to return for follow up visit
Who cannot join
- Mentally handicapped
- Unable to understand written and oral English
- Unwilling to return for follow up
- Wounds less than 3 cm in length
- Adults unable to consent
- Individuals who are not yet adults (infants, children, teenagers 17 and under)
- Pregnant women
- Prisoners
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California-Davis, Department of Dermatology
Sacramento, California, 95816
About this study
To determine whether the addition of adhesive stripping to a wound closed with dermal sutures improves outcome of wound closure. We hypothesize that the combination of adhesive strips to a wound closed with dermal sutures does not add significant cosmetic improvement of the resultant scar.
- Being tested
- Suture with Adhesive Stripping, Suture without Adhesive Stripping
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Suture with Adhesive StrippingProcedure or surgery
Suture without Adhesive StrippingProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Suture with Adhesive Stripping | Active comparator | Buried dissolving subcuticular sutures are sued for both sides of the wound to approximate wound edges and then steri-strips for the adhesive stripped half of the scar is applied. Receives: Procedure: Suture with Adhesive Stripping; Procedure: Suture without Adhesive Stripping |
| Suture without Adhesive Stripping | Active comparator | Buried dissolving subcuticular sutures are sued for both sides of the wound to approximate wound edges and then no closure material for the half of the scar is applied. Receives: Procedure: Suture with Adhesive Stripping; Procedure: Suture without Adhesive Stripping |
What is being measured
The primary outcome is the main question the study is designed to answer.
Split-Scar Comparison
Split-scar comparison of half of the wound closed with buried subcuticular sutures and overlying adhesive strips and half the wound closed with buried subcuticular sutures alone.
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 Nov 2013 (estimated)
- Study startAug 2013
- Primary completionJun 2014
- Study completionJun 2014
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 Subjects Undergoing Surgical Procedure of the SkinStudies 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
- Factorial
- Masking
- None (open label)
- Enrolment
- 39 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
- NCT01979497
- Sponsor's protocol ID
- 451808
- Other IDs
- 451808
- Status last verified
- Apr 2015
- First submitted
- 1 Nov 2013
- Last updated
- 16 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Custis T, Armstrong AW, King TH, Sharon VR, Eisen DB. Effect of Adhesive Strips and Dermal Sutures vs Dermal Sutures Only on Wound Closure: A Randomized Clinical Trial. JAMA Dermatol. 2015 Aug;151(8):862-7. doi: 10.1001/jamadermatol.2015.0174.
PubMed 25875131
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
- Adhesive Strips in Dermatologic Surgery: Is Cosmetic Appearance Improved?
- ClinicalTrials.gov ID
- NCT01979497
- Acronym / sponsor ID
- 451808
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 8 Nov 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.
To determine whether the addition of adhesive stripping to a wound closed with dermal sutures improves outcome of wound closure. We hypothesize that the combination of adhesive strips to a wound closed with dermal sutures does not add significant cosmetic improvement of the resultant scar.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Suture with Adhesive Stripping | Active comparator | Procedure: Suture with Adhesive Stripping, Procedure: Suture without Adhesive StrippingBuried dissolving subcuticular sutures are sued for both sides of the wound to approximate wound edges and then steri-strips for the adhesive stripped half of the scar is applied. |
| Suture without Adhesive Stripping | Active comparator | Procedure: Suture with Adhesive Stripping, Procedure: Suture without Adhesive StrippingBuried dissolving subcuticular sutures are sued for both sides of the wound to approximate wound edges and then no closure material for the half of the scar is applied. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years of age or older
- Able to give informed consent themselves
- Willing to return for follow up visit
Key exclusion criteria (8 listed)
- Mentally handicapped
- Unable to understand written and oral English
- Unwilling to return for follow up
- Wounds less than 3 cm in length
- Adults unable to consent
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 |
|---|---|---|
| Suture with Adhesive Stripping | Procedure or surgery | Suture with Adhesive Stripping, Suture without Adhesive Stripping |
| Suture without Adhesive Stripping | Procedure or surgery | Suture with Adhesive Stripping, Suture without Adhesive Stripping |
Primary outcome
Split-Scar Comparison
Time frame: 3 months
Split-scar comparison of half of the wound closed with buried subcuticular sutures and overlying adhesive strips and half the wound closed with buried subcuticular sutures alone.
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.
- Derived from this study: PubMed 25875131Custis T, Armstrong AW, King TH, Sharon VR, Eisen DB. Effect of Adhesive Strips and Dermal Sutures vs Dermal Sutures Only on Wound Closure: A Randomized Clinical Trial. JAMA Dermatol. 2015 Aug;151(8):862-7. doi: 10.1001/jamadermatol.2015.0174.
- University of California-Davis Department of Dermatology Clinical ResearchLink provided by the sponsor.
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 Suture with Adhesive Stripping and Suture without Adhesive Stripping in people with Subjects Undergoing Surgical Procedure of the Skin, 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 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 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?
Split-Scar Comparison (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 NCT01979497, 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 16 Apr 2015.