ClinicalTrials.gg
CompletedNCT03302988Updated Sep 24, 2018

Wound Eversion Versus Planar Closure for Face or Neck Wounds

An interventional study of Everted closure and Planar closure in Operative Wound, sponsored by University of California, Davis. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-09-24.

Sponsored by University of California, Davis · Not applicable, Interventional, and Other

From the registry’s dates

  • Registered 1 year 11 months after the study started (first participant enrolled Oct 2015, registered Oct 2017).

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Phase
Not applicable
Study type
Interventional
Enrollment
33
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 129 studies in Surgical Wound with a site in United States — 17 open to participants now, 21 under way, none of them phase 3. Surgical Wound · United States.

Enrollment
67th of 111
33 · median 50
Started
2015
with 3 others
No phase
88 of 129
9 open now
Registered
49th of 129
by date
Lead sponsor
3 of 129
University of California, Davis

Among the 129 studies in Surgical Wound with a site in United States, this one is the 67th largest by enrollment of the 111 interventional ones that give a count, is one of 4 that started in 2015, is one of 88 with no phase, and was the 49th registered.

Surgical Wound

315 studies on the registry are indexed under Surgical Wound; 57 are open to participants now.

Browse Surgical Wound studies →

Open to participants now

17 of the 129 studies in Surgical Wound with a site in United States are open now. Recruiting first, the newest first:

12 more — sign in →

All 17 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 33 Surgical Wound studies recruiting now, 19 (58%) set no upper age limit and 10 (30%) stop at 75 or younger; 6 take children under 18; 7 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 129 studies in Surgical Wound with a site in United States, or all of them as a file.
02

Study summary

The aim of this study is to determine whether wound edge eversion, achieved by careful placement of dermal sutures, improves the cosmetic outcome of operative wounds closed on the head or neck.

Read the detailed description

It has been established that as wounds heal, the resultant tissue remodeling results in wound contracture. Surgeons are taught that by everting wounds' edges with well-placed dermal sutures, there is less depression of the resultant scar. A prior study conducted by us at this center found that wound eversion was not associated with better cosmetic outcome (1). However, it was noted that most of the procedures were performed off the head and neck, places where the effects of eversion were thought to be most beneficial (2) Thus our goal is to now study the effects of eversion exclusively on the face and neck.

03

Conditions studied

  • Operative Wound

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Keywords

  • Wound Edge Eversion
  • Dermal Sutures
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Over 18 years of age
  • Able to give themselves
  • Patient scheduled for cutaneous surgical procedure with predicted linear closure on the face or neck
  • Willing to return for follow up visits

Exclusion criteria

Exclusion Criteria:

  • Mentally handicapped
  • Unable to understand written and oral English
  • Incarceration
  • Under 18 years of age
  • Pregnant Women
  • Adults unable to consent
  • Individuals who are not yet adults (infants, children, teenagers)
  • Pregnant women
  • Prisoners
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Factorial assignment
Masking
None (open label)
Enrollment
33 participants (actual)

Study arms

  • Experimental
    Everted closure

    Wound eversion will be achieved through buried vertical mattress suture or cuticular suture based on surgeon's preference, either buried vertical mattress suture or cuticular sutures

    Other: Everted closure

  • Active comparator
    Planar closure

    The planar side of the same wond will be closed with traditional buried simple closure and running cuticular sutures

    Other: Planar closure

Interventions

  • OtherEverted closure

    Suturing technique to obtain wound eversion. Type of suturing technique at surgeon's discretion

  • OtherPlanar closure

    The planar side will be closed with traditional buried simple closure and running cuticular sutures

06

What researchers measure

Primary outcomes

  1. Patient Observer Scar Assessment Scale (POSAS)

    The primary endpoint will be the score of two blinded reviewers using the physician observer assessment score at a three-month assessment visit.

    Time frame: Within 3 months

  2. Incidence of sunken scars

    The incidence of sunken scars or elevated scaring on each treatment side will also be determined

    Time frame: Within 3 months

07

Study locations

1 site
  • University of California, Davis, Department of Dermatology
    Sacramento, California 95816, United States
08

References and documents

Publications

  • Kappel S, Kleinerman R, King TH, Sivamani R, Taylor S, Nguyen U, Eisen DB. Does wound eversion improve cosmetic outcome?: Results of a randomized, split-scar, comparative trial. J Am Acad Dermatol. 2015 Apr;72(4):668-73. doi: 10.1016/j.jaad.2014.11.032. Epub 2015 Jan 23. PubMed 25619206 ↗
  • Trufant JW, Leach BC. Commentary: Wound edge eversion: surgical dogma or diversion? J Am Acad Dermatol. 2015 Apr;72(4):681-2. doi: 10.1016/j.jaad.2014.09.046. No abstract available. PubMed 25773410 ↗
  • van de Kar AL, Corion LU, Smeulders MJ, Draaijers LJ, van der Horst CM, van Zuijlen PP. Reliable and feasible evaluation of linear scars by the Patient and Observer Scar Assessment Scale. Plast Reconstr Surg. 2005 Aug;116(2):514-22. doi: 10.1097/01.prs.0000172982.43599.d6. PubMed 16079683 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Oct 2015 to primary completion in Jul 2016, 8 months.

Of 99 non-industry interventional studies with no phase under Surgical Wound, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 53. This study's 8 months is below that.

Counting every sponsor, half of 126 studies reached it within 18 months; a quarter within 9 and three quarters within 42.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 2, 2017
First posted
Oct 5, 2017
StartActual
Oct 13, 2015
Primary completionActual
Jul 6, 2016
CompletionActual
Jul 25, 2017
Last update
Sep 24, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 24, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03302988
Responsible party
Sponsor
First posted
Oct 5, 2017
Start date
Oct 13, 2015
Primary completion
Jul 6, 2016
Completion
Jul 25, 2017
Last update
Sep 24, 2018

Study contacts

Daniel Eisen, MD
principal investigator · University of California, Davis

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2018. You cannot join it, but the record below documents what was studied.

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