Surgical IncisionsNCT00872638
The Effect of Wound Edge Eversion on Cosmesis
A study testing Eversion and Approximation in people with Surgical Incisions, run by Stony Brook University at 1 site in United States.
Trial summary
Aesthetic appearance of repaired incisions is very important to surgical patients. It has been stated that if the edges of a wound are closed in such a manner that will result in eversion, or pouting of the edges that the end cosmetic result will be superior when compared to wound edges that are simply approximated. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgical Incisions
- What is being tested?
- Eversion and Approximation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2008to Apr 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
- age over 18.
- able to consent.
- scheduled for elective plastic or cardiothoracic surgery.
Who cannot join
- history of keloids, hypertrophic scarring, diabetes, or peripheral vascular disease.
- those requiring systemic steroids or undergoing chemotherapy, and those unable or unwilling to consent.
Trial locations and contacts
1 site in 1 country.
United States1 site
Stony Brook University Medical Center
Stony Brook, New York, 11794
About this study
Aesthetic appearance of repaired incisions is very important to surgical patients. It has been stated that if the edges of a wound are closed in such a manner that will result in eversion, or pouting of the edges that the end cosmetic result will be superior when compared to wound edges that are simply approximated. The purpose of this study is to compare cosmetic outcomes of incisions that are closed with everted edges to those in which the edges are simply approximated.
Read the detailed description
Surgical incisions will be split into two halfs and each half will be randomized to standard or everting sutures. 3 months later the cosmetic outcome of the healed wounds will be determined using a validated scar evaluation scale.
- Conditions
- Surgical Incisions
- Being tested
- Eversion, Approximation
- Keywords
- wound edge eversion, cosmetic outcomes, surgical incisions
- Medical subject headings
- Surgical Wound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EversionProcedure or surgery
Also called mattress sutures
Surgical incisions will be closed in such a manner so as to evert the wound edges.
ApproximationProcedure or surgery
Also called simple suture
Surgical incisions will be closed in such a manner so that wound edges are approximated exactly, i.e. without eversion.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Not described Receives: Procedure: Eversion |
| 2 | Active comparator | Not described Receives: Procedure: Approximation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cosmetic result of surgical incision as measured by VAS scale
Measured: 1 year
Secondary outcomes (1)
Cosmetic Results as measured by the Stony Brook Scar Scale
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2009 (estimated)
- Study startJan 2008
- Primary completionJan 2016 (estimated)
- Study completionApr 2016 (estimated)
Why it stopped: lack of participation
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical IncisionsStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stony Brook University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adam Singer, Stony Brook University
- Investigators
- Adam Singer, MD, Principal investigator, Stony Brook University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00872638
- Sponsor's protocol ID
- 20076828
- Status last verified
- May 2015
- First submitted
- 28 Mar 2009
- Last updated
- 1 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Wound Edge Eversion on Cosmesis
- ClinicalTrials.gov ID
- NCT00872638
- Acronym / sponsor ID
- 20076828
- Conditions
- Surgical Incisions
- Keywords
- wound edge eversion, cosmetic outcomes, surgical incisions
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: lack of participation
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Stony Brook UniversityUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Jan 2016 (estimated)
- Study completion
- Apr 2016 (estimated)
- First posted
- 31 Mar 2009 (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.
Aesthetic appearance of repaired incisions is very important to surgical patients. It has been stated that if the edges of a wound are closed in such a manner that will result in eversion, or pouting of the edges that the end cosmetic result will be superior when compared to wound edges that are simply approximated. The purpose of this study is to compare cosmetic outcomes of incisions that are closed with everted edges to those in which the edges are simply approximated.
Detailed description
Surgical incisions will be split into two halfs and each half will be randomized to standard or everting sutures. 3 months later the cosmetic outcome of the healed wounds will be determined using a validated scar evaluation scale.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Procedure: Eversion |
| 2 | Active comparator | Procedure: Approximation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age over 18.
- able to consent.
- scheduled for elective plastic or cardiothoracic surgery.
Key exclusion criteria (2 listed)
- history of keloids, hypertrophic scarring, diabetes, or peripheral vascular disease.
- those requiring systemic steroids or undergoing chemotherapy, and those unable or unwilling 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 |
|---|---|---|
| EversionAlso: mattress suturesSurgical incisions will be closed in such a manner so as to evert the wound edges. | Procedure or surgery | 1 |
| ApproximationAlso: simple sutureSurgical incisions will be closed in such a manner so that wound edges are approximated exactly, i.e. without eversion. | Procedure or surgery | 2 |
Primary outcome
Cosmetic result of surgical incision as measured by VAS scale
Time frame: 1 year
1 secondary outcome
Cosmetic Results as measured by the Stony Brook Scar Scale
Time frame: 1 year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2015.
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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.
Adam Singer, MD principal investigator
Stony Brook University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Eversion and Approximation in people with Surgical Incisions, run by Stony Brook University 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 2 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: withdrawn, as of the sponsor's last update on 1 Jun 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 was withdrawn before enrolling participants, so there are no results.
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?
Cosmetic result of surgical incision as measured by VAS scale (time frame: 1 year). 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 1 Jun 2015.