ClinicalTrials.gg
TerminatedNCT03425370Updated Nov 2, 2018

Effect of Replacing Buried Sutures With Tissue Adhesive on Aesthetic Outcome of Surgical Wounds.

An interventional study of Closure of surgical wounds using buried sutures or tissue adhesive on aesthetic outcome. in Surgical Wound, sponsored by West Virginia University. Terminated at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-11-02.

Sponsored by West Virginia University · Not applicable, Interventional, and Other

Why this study was terminated
Wound dehiscence on tissue adhesive side of 1 wound which developed an infection.

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Phase
Not applicable
Study type
Interventional
Enrollment
10
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
93rd of 111
10 · median 50
Started
2018
with 11 others
No phase
88 of 129
9 open now
Registered
52nd of 129
by date

Among the 129 studies in Surgical Wound with a site in United States, this one is the 93rd largest by enrollment of the 111 interventional ones that give a count, is one of 12 that started in 2018, is one of 88 with no phase, and was the 52nd 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 · healthy volunteers too.

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02

Study summary

Surgery wounds are typically closed with combination of absorbable stitches placed under the skin and non-absorbable stitched placed at the skin surface. Absorbable sutures can produce unwanted side effects when the body produces a reaction to them. The investigators are conducting a study to determine if absorbable stitches can be replaced but tissue glue applied on the surface of the skin. If participants enroll in the study, the investigators will close one half of the participants wound with absorbable stitches placed under the skin and non-absorbable stitches on the surface. The other half of the wound will be closed with non-absorbable stitches and tissue glue. The appearance of the scar (if any) will then be evaluated at 3- and 6-month follow-ups by two dermatologists (either board-certified dermatologists or dermatology residents) and the patient.

03

Conditions studied

  • Surgical Wound

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Keywords

  • Surgical wounds
  • Tissue adhesive
  • Sutures
  • Wound healing
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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

  • Age 18 years or older
  • Postoperative defects of at least 3 cm, resulting from either Mohs micrographic surgery or surgical excision
  • Willing to give and return for follow-up visits 3 months and 6 months following surgery

Exclusion criteria

Exclusion Criteria:

  • Pregnant
  • Unable to understand English
  • Mentally impaired
  • Incarcerated
  • Has nonlinear closures
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
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
10 participants (actual)

Study arms

  • Experimental
    Wound Side A: buried sutures, Wound Side B: tissue adhesive

    Wounds halves will be labeled as A (left/superior) or B (right/inferior), the halves will be randomized to receive either tissue glue or deep sutures.

    Procedure: Closure of surgical wounds using buried sutures or tissue adhesive on aesthetic outcome.

  • Experimental
    Wound Side A: tissue adhesive, Wound Side B: buried sutures

    Wounds halves will be labeled as A (left/superior) or B (right/inferior), the halves will be randomized to receive either tissue glue or deep sutures.

    Procedure: Closure of surgical wounds using buried sutures or tissue adhesive on aesthetic outcome.

Interventions

  • ProcedureClosure of surgical wounds using buried sutures or tissue adhesive on aesthetic outcome.

    Effect of replacing buried sutures with tissue adhesive on aesthetic outcome of surgical wounds will be measured using the POSAS.

06

What researchers measure

Primary outcomes

  1. Rating the healing progression of the wound

    By observation using the Patient-Observer Scar Assessment Scale (POSAS)

    Time frame: 3 months after surgical wound closure

  2. Rating the healing progression of the wound

    By observation using the Patient-Observer Scar Assessment Scale (POSAS)

    Time frame: 6 months after surgical wound closure

07

Study locations

1 site
  • West Virginia University University Town Centre Dermatology Clinic
    Morgantown, West Virginia 26501, United States
08

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jan 2018 to primary completion in Oct 2018, 9 months.

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

Registered
Jan 25, 2018
First posted
Feb 7, 2018
StartActual
Jan 26, 2018
Primary completionActual
Oct 31, 2018
CompletionActual
Oct 31, 2018
Last update
Nov 2, 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 Nov 2, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03425370
Responsible party
Michael Kolodney (Dermatology Section Chief, West Virginia University) — Principal investigator
First posted
Feb 7, 2018
Start date
Jan 26, 2018
Primary completion
Oct 31, 2018
Completion
Oct 31, 2018
Last update
Nov 2, 2018

Study contacts

Michael S Kolodney, MD, PhD
principal investigator · West Virginia University

Oversight

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

Not currently enrolling

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

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