Interrupted Subdermal SutureNCT03327922

Interrupted Subdermal Suture Spacing During Linear Wound Closures and the Effect on Wound Cosmesis

A study testing Vicryl absorbable suture in people with Interrupted Subdermal Suture, run by University of California, Davis at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Interrupted Subdermal Suture
What is being tested?: Vicryl absorbable suture
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 50 participants
Where: 1 siteUnited States
Study dates: 20 Sep 2017to 2 Mar 2022
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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
Patient scheduled for cutaneous surgical procedure on the trunk and extremities with predicted primary closure
Willing to return for follow up visit.

Who cannot join

Mentally handicapped
Unable to understand written and oral English
Incarceration
Under 18 years of age
Pregnant Women
Wounds with predicted closure length less than 4 cm

Trial locations and contacts

1 site in 1 country.

United States1 site

University of California, Davis, Department of Dermatology
Sacramento, California, 95816

Other trials in United States

About this study

Official title: Interrupted Subdermal Suture Spacing During Linear Wound Closures and the Effect on Wound Cosmesis: a Randomized Evaluator Blinded Split Wound Comparative Effectiveness Trial

Read the detailed description

Sutures are the standard of care in repairing cutaneous wounds. The majority of surgical reconstructions following a Mohs micrographic surgery and standard surgical excisions require two layers of sutures: a deep layer and a top layer. The deep layer dissolves naturally whereas the top layer must be removed.

This study aims to investigate whether the spacing of the interrupted deep (subdermal) sutures affects surgical wound cosmesis on the trunk and extremities. In other words, the investigator would like to determine which of the following yields a more cosmetically appealing scar: many closely approximated subdermal sutures or fewer, more widely spaced subdermal sutures. The investigator wishes to compare the effects of one versus two centimeter spacing between sutures. It is possible that fewer, more widely spaced sutures may leave more open space in the wound, leaving more tension to pull on those few sutures, possibly encouraging the wound to dehisce and make it harder to approximate the wound edges yielding a less cosmetically appealing scar compared to placing many closely approximated sutures which would decrease the tension and likely better approximate the wound edges yielding a more cosmetically appealing scar. On the other hand, we may find that suture spacing has no effect on wound cosmesis and that placing fewer, more widely spaced sutures is much more time efficient. The investigator may also find that the effect of suture spacing on wound cosmesis is dependent on wound tension. For example, perhaps the suture pacing would have no effect on the cosmesis of a wound under no tension, however, for a wound under high tension, it is possible that many closely approximated sutures would yield better cosmetic results for the reasons listed above.

Conditions: Interrupted Subdermal Suture
Being tested: Vicryl absorbable suture
Keywords: Subdermal, Suture, Wound Closure, Wound Cosmesis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Vicryl absorbable sutureDevice
Vicryl absorbable suture is a synthetic sterile surgical suture made up of a copolymer

Study groups in NCT03327922
Study group	Role	What they receive
Vicryl absorbable suture placed 2 cm apart	Experimental	Wound closed with sutures spaced 2 centimeters apart will be treated in a simple, interrupted subdermal suture pattern Receives: Device: Vicryl absorbable suture
Vicryl absorbable suture placed 1 cm apart	Experimental	Wound closed with sutures spaced 1 centimeter apart will be treated in a simple, interrupted subdermal suture pattern Receives: Device: Vicryl absorbable suture

What is being measured

The primary outcome is the main question the study is designed to answer.

Patient and Observer Scar Assessment Scale - Reviewer 1
The primary endpoint will be the score of two blinded reviewers using the patient observer scar assessment score (POSAS). The POSAS measures scar quality in all types of scars by evaluating visual (e.g. color), tactile (e.g. pliability) and sensory (e.g. itch) characteristics of the scar from the perspective of the observer and patients. Scores for each subscale range from 1 to 10, for a sum score range from 6 to 60. Low scores indicate better outcomes.
Measured: 3 months following procedure
Patient and Observer Scar Assessment Scale - Reviewer 2
The primary endpoint will be the score of two blinded reviewers using the patient observer scar assessment score (POSAS). The POSAS measures scar quality in all types of scars by evaluating visual (e.g. color), tactile (e.g. pliability) and sensory (e.g. itch) characteristics of the scar from the perspective of the observer and patients. Scores for each subscale range from 1 to 10, for a sum score range from 6 to 60. Low scores indicate better outcomes.
Measured: 3 months following procedure

Secondary outcomes (2)

Width of Scar
A secondary endpoint will include the width of the scar 1 cm from midline on each side
Measured: 3 months following procedure
Complications
Any complications including suture reaction, dehiscence, infection, necrosis, bleeding, and hematoma
Measured: 3 months following procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 Sep 20172 Mar 2022

First posted1 Nov 2017
Study start20 Sep 2017
Primary completion2 Mar 2022
Study completion2 Mar 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Interrupted Subdermal SutureStudies 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
Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Model description: At the follow-up visit, two blinded observers will record their scores independently using the physician observer scar assessment score instrument (POSAS).
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 50 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03327922
Sponsor's protocol ID: 1115591
Status last verified: Feb 2026
First submitted: 27 Oct 2017
Last updated: 13 Mar 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: Undecided

Publications

Eshagh K, Sklar LR, Pourang A, Armstrong AW, Dhaliwal H, Eisen DB. Interrupted subcuticular suture spacing during linear wound closures and the effect on wound cosmesis: a randomized evaluator-blinded split-wound comparative effectiveness trial. Br J Dermatol. 2022 Sep;187(3):318-323. doi: 10.1111/bjd.21625. Epub 2022 Jun 13.
PubMed 35474448

Study at a glance

From the registry record, last updated by the sponsor on 13 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Interrupted Subdermal Suture Spacing During Linear Wound Closures and the Effect on Wound Cosmesis: a Randomized Evaluator Blinded Split Wound Comparative Effectiveness Trial
ClinicalTrials.gov ID: NCT03327922
Acronym / sponsor ID: 1115591
Conditions: Interrupted Subdermal Suture
Keywords: Subdermal, Suture, Wound Closure, Wound Cosmesis
Study type: Interventional
Recruitment status: Completed
Enrolment: 50 participants (actual)
Lead sponsor: University of California, DavisUniversity, hospital or other
Study start: 20 Sep 2017 (actual)
Primary completion: 2 Mar 2022 (actual)
Study completion: 2 Mar 2022 (actual)
First posted: 1 Nov 2017 (actual)
Results: Posted 13 Mar 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2
Model description: At the follow-up visit, two blinded observers will record their scores independently using the physician observer scar assessment score instrument (POSAS).

Arm	Type	Receives
Vicryl absorbable suture placed 2 cm apart	Experimental	Device: Vicryl absorbable sutureWound closed with sutures spaced 2 centimeters apart will be treated in a simple, interrupted subdermal suture pattern
Vicryl absorbable suture placed 1 cm apart	Experimental	Device: Vicryl absorbable sutureWound closed with sutures spaced 1 centimeter apart will be treated in a simple, interrupted subdermal suture pattern

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

18 years of age or older
Able to give informed consent themselves
Patient scheduled for cutaneous surgical procedure on the trunk and extremities with predicted primary closure
Willing to return for follow up visit.

Key exclusion criteria (6 listed)

Mentally handicapped
Unable to understand written and oral English
Incarceration
Under 18 years of age
Pregnant Women

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
Vicryl absorbable sutureVicryl absorbable suture is a synthetic sterile surgical suture made up of a copolymer	Device	Vicryl absorbable suture placed 1 cm apart, Vicryl absorbable suture placed 2 cm apart

Primary outcome

Patient and Observer Scar Assessment Scale - Reviewer 1
Time frame: 3 months following procedure
The primary endpoint will be the score of two blinded reviewers using the patient observer scar assessment score (POSAS). The POSAS measures scar quality in all types of scars by evaluating visual (e.g. color), tactile (e.g. pliability) and sensory (e.g. itch) characteristics of the scar from the perspective of the observer and patients. Scores for each subscale range from 1 to 10, for a sum score range from 6 to 60. Low scores indicate better outcomes.
Patient and Observer Scar Assessment Scale - Reviewer 2
Time frame: 3 months following procedure
The primary endpoint will be the score of two blinded reviewers using the patient observer scar assessment score (POSAS). The POSAS measures scar quality in all types of scars by evaluating visual (e.g. color), tactile (e.g. pliability) and sensory (e.g. itch) characteristics of the scar from the perspective of the observer and patients. Scores for each subscale range from 1 to 10, for a sum score range from 6 to 60. Low scores indicate better outcomes.

2 secondary outcomes

Width of Scar
Time frame: 3 months following procedure
Complications
Time frame: 3 months following procedure

Results and safety

Results posted to the registry on 13 Mar 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Vicryl Absorbable Suture Placed 2 cm Apart	50	46
Vicryl Absorbable Suture Placed 1 cm Apart	50	46

Primary outcome: Patient and Observer Scar Assessment Scale - Reviewer 1

Time frame: 3 months following procedure. Mean (Full Range). Unit: score on a scale

Measure	Vicryl Absorbable Suture Placed 2 cm Apart n = 46	Vicryl Absorbable Suture Placed 1 cm Apart n = 46
Sum of Observer POSAS	13.14 (8 to 28)	12.40 (8 to 32)
Vascularity	2.46 (1 to 6)	2.23 (1 to 6)
Pigmentation	2.07 (1 to 4)	1.96 (1 to 5)
Thickness	2.52 (1 to 6)	2.34 (1 to 6)
Relief	2.56 (1 to 8)	2.36 (1 to 5)
Pliability	2.67 (1 to 5)	2.73 (1 to 7)
Surface Area	2.62 (1 to 7)	2.43 (1 to 7)
Overall Opinion	2.84 (1 to 7)	2.66 (1 to 7)

Vicryl Absorbable Suture Placed 2 cm Apart vs Vicryl Absorbable Suture Placed 1 cm Apart: p <0.05, t-test, 2 sided

Population analysed: Out of 46 patients, each patient's wound was then divided into 2 sides: A and B. An intervention was randomly assigned to each side of the wound, for a total of 92 wound halves.

Primary outcome: Patient and Observer Scar Assessment Scale - Reviewer 2

Time frame: 3 months following procedure. Mean (Full Range). Unit: score on a scale

Measure	Vicryl Absorbable Suture Placed 2 cm Apart n = 46	Vicryl Absorbable Suture Placed 1 cm Apart n = 46
Sum of POSAS	14.63 (6 to 33)	13.33 (6 to 27)
Pain	1.02 (1 to 2)	1.00 (1 to 1)
Itching	1.13 (1 to 6)	1.07 (1 to 3)
Color	3.00 (1 to 8)	2.78 (1 to 8)
Stiffness	2.85 (1 to 9)	2.67 (1 to 8)
Thickness	2.44 (1 to 8)	2.24 (1 to 8)
Irregularity	2.94 (1 to 10)	2.59 (1 to 10)
Overall opinion	2.85 (1 to 8)	2.44 (1 to 7)

Vicryl Absorbable Suture Placed 2 cm Apart vs Vicryl Absorbable Suture Placed 1 cm Apart: p <0.05, t-test, 2 sided

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Any data about adverse events was collected over the 3 months following the patient's procedure.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Vicryl Absorbable Suture Placed 2 cm Apart	0 of 50 (0%)	0 of 50 (0%)	0 of 50
Vicryl Absorbable Suture Placed 1 cm Apart	0 of 50 (0%)	0 of 50 (0%)	0 of 50

Limitations and caveats (from the sponsor): The primary limitation of our study includes its single center nature. A multicenter study would allow for narrower confidence intervals and a more diverse patient population.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 35474448Eshagh K, Sklar LR, Pourang A, Armstrong AW, Dhaliwal H, Eisen DB. Interrupted subcuticular suture spacing during linear wound closures and the effect on wound cosmesis: a randomized evaluator-blinded split-wound comparative effectiveness trial. Br J Dermatol. 2022 Sep;187(3):318-323. doi: 10.1111/bjd.21625. Epub 2022 Jun 13.
Individual participant dataSharing planned: Undecided

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?

A study testing Vicryl absorbable suture in people with Interrupted Subdermal Suture, 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 4 inclusion and 6 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 13 Mar 2026. 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?

Yes. Results are posted in the registry (first posted 13 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Patient and Observer Scar Assessment Scale - Reviewer 1 (time frame: 3 months following procedure). The study lists 2 primary outcomes in all. 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 NCT03327922, 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 13 Mar 2026.