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

Primary Purpose

Interrupted Subdermal Suture

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Vicryl absorbable suture
Sponsored by
University of California, Davis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Interrupted Subdermal Suture focused on measuring Subdermal, Suture, Wound Closure, Wound Cosmesis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Sites / Locations

  • University of California, Davis, Department of Dermatology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Vicryl absorbable suture placed 2 cm apart

Vicryl absorbable suture placed 1 cm apart

Arm Description

Wound closed with sutures spaced 2 centimeters apart will be treated in a simple, interrupted subdermal suture pattern

Wound closed with sutures spaced 1 centimeter apart will be treated in a simple, interrupted subdermal suture pattern

Outcomes

Primary Outcome Measures

Scar Assessment
The primary endpoint will be the score of two blinded reviewers using the patient observer scar assessment score.

Secondary Outcome Measures

Width of Scar
A secondary endpoint will include the width of the scar 1 cm from midline on each side
Erythema
If one half of the scar has more associated erythema, this will be noted

Full Information

First Posted
October 27, 2017
Last Updated
June 6, 2022
Sponsor
University of California, Davis
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1. Study Identification

Unique Protocol Identification Number
NCT03327922
Brief Title
Interrupted Subdermal Suture Spacing During Linear Wound Closures and the Effect on Wound Cosmesis
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
September 20, 2017 (Actual)
Primary Completion Date
March 2, 2022 (Actual)
Study Completion Date
March 2, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, Davis

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Interrupted Subdermal Suture
Keywords
Subdermal, Suture, Wound Closure, Wound Cosmesis

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
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
Outcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vicryl absorbable suture placed 2 cm apart
Arm Type
Experimental
Arm Description
Wound closed with sutures spaced 2 centimeters apart will be treated in a simple, interrupted subdermal suture pattern
Arm Title
Vicryl absorbable suture placed 1 cm apart
Arm Type
Experimental
Arm Description
Wound closed with sutures spaced 1 centimeter apart will be treated in a simple, interrupted subdermal suture pattern
Intervention Type
Device
Intervention Name(s)
Vicryl absorbable suture
Intervention Description
Vicryl absorbable suture is a synthetic sterile surgical suture made up of a copolymer
Primary Outcome Measure Information:
Title
Scar Assessment
Description
The primary endpoint will be the score of two blinded reviewers using the patient observer scar assessment score.
Time Frame
3 months following procedure
Secondary Outcome Measure Information:
Title
Width of Scar
Description
A secondary endpoint will include the width of the scar 1 cm from midline on each side
Time Frame
3 months following procedure
Title
Erythema
Description
If one half of the scar has more associated erythema, this will be noted
Time Frame
3 months following procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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
Facility Information:
Facility Name
University of California, Davis, Department of Dermatology
City
Sacramento
State/Province
California
ZIP/Postal Code
95816
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
35474448
Citation
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.
Results Reference
derived

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

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