Wound CosmesisNCT01938586
Comparison of Traditional Superficial Cutaneous Sutures Versus Steri-Strip Coaptive Film in Layered Dermatologic Closures
An observational study of Wound Cosmesis, run by Henry Ford Health System at 1 site in United States.
Trial summary
The purpose of this study is to compare the cosmetic outcome between buried intradermal and superficial cutaneous suture closures versus buried intradermal sutureand superficial Steri-Strip closures in the bilayered repair of dermatologic wounds on the back following elliptical excision of benign or malignant lesions Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Wound Cosmesis
- What is being tested?
- Steri-Strip and Superficial sutures
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2013to Aug 2014
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Outpatient dermatology clinic
Who may be able to join
- 18 years or greater in age
- Simple excision of benign or malignant lesion on the back
- Final scar length of at least 3cm
Who cannot join
- Known history of keloid formation or hypertrophic scars
- Known adhesive allergy
- Pregnancy or active breast feeding
Trial locations and contacts
1 site in 1 country.
United States1 site
Henry Ford Dermatology Clinic
Detroit, Michigan, 48202
About this study
Official title: Comparison of Traditional Superficial Cutaneous Sutures Versus Steri-Strip Coaptive Film in Layered Dermatologic Closures on the Back - a Prospective, Randomized, Split-scar Study
The purpose of this study is to compare the cosmetic outcome between buried intradermal and superficial cutaneous suture closures versus buried intradermal sutureand superficial Steri-Strip closures in the bilayered repair of dermatologic wounds on the back following elliptical excision of benign or malignant lesions
- Conditions
- Wound Cosmesis
- Being tested
- Steri-Strip, Superficial sutures
- Keywords
- Scar, Appearance
- Medical subject headings
- Cicatrix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Steri-StripOther
Superficial suturesOther
| Study group | Role | What they receive |
|---|---|---|
| Surgical excision | Not described Receives: Other: Steri-Strip; Other: Superficial sutures |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall scar appearance as evaluated by the Patient and Observer Scar Assessment Scale
Measured: 6 months
Secondary outcomes (2)
Rates of postoperative complications
Assessment of scar erythema, swelling, infection, drainage, dehiscence
Measured: 6 months
Time for closure of each split half portion of wound
Measured: 1 hour (intraoperative)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2013 (estimated)
- Study startNov 2013
- Primary completionJun 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wound CosmesisStudies of the same condition, open and under way.
- More trials run by Henry Ford Health SystemThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henry Ford Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David M. Ozog, Henry Ford Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01938586
- Sponsor's protocol ID
- SYDO-2013
- Status last verified
- Sep 2013
- First submitted
- 5 Sep 2013
- Last updated
- 15 Apr 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Traditional Superficial Cutaneous Sutures Versus Steri-Strip Coaptive Film in Layered Dermatologic Closures on the Back - a Prospective, Randomized, Split-scar Study
- ClinicalTrials.gov ID
- NCT01938586
- Acronym / sponsor ID
- SYDO-2013
- Conditions
- Wound Cosmesis
- Keywords
- Scar, Appearance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Henry Ford Health SystemUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Jun 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 10 Sep 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 purpose of this study is to compare the cosmetic outcome between buried intradermal and superficial cutaneous suture closures versus buried intradermal sutureand superficial Steri-Strip closures in the bilayered repair of dermatologic wounds on the back following elliptical excision of benign or malignant lesions
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Surgical excision | – | Other: Steri-Strip, Other: Superficial sutures |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Outpatient dermatology clinic
Key inclusion criteria (3 listed)
- 18 years or greater in age
- Simple excision of benign or malignant lesion on the back
- Final scar length of at least 3cm
Key exclusion criteria (3 listed)
- Known history of keloid formation or hypertrophic scars
- Known adhesive allergy
- Pregnancy or active breast feeding
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 |
|---|---|---|
| Steri-Strip | Other | Surgical excision |
| Superficial sutures | Other | Surgical excision |
Primary outcome
Overall scar appearance as evaluated by the Patient and Observer Scar Assessment Scale
Time frame: 6 months
2 secondary outcomes
Rates of postoperative complications
Time frame: 6 months
Time for closure of each split half portion of wound
Time frame: 1 hour (intraoperative)
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 15 Apr 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Wound Cosmesis, run by Henry Ford Health System 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 3 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 15 Apr 2016. 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?
Overall scar appearance as evaluated by the Patient and Observer Scar Assessment Scale (time frame: 6 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 15 Apr 2016.