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

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

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.

Study Overview

• Status: Completed
• Conditions: Interrupted Subdermal Suture
• Intervention / Treatment: Device: Vicryl absorbable suture

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.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: FACTORIAL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Vicryl absorbable suture placed 2 cm apart; Wound closed with sutures spaced 2 centimeters apart will be treated in a simple, interrupted subdermal suture pattern	Device: Vicryl absorbable suture; Vicryl absorbable suture is a synthetic sterile surgical suture made up of a copolymer
EXPERIMENTAL: Vicryl absorbable suture placed 1 cm apart; Wound closed with sutures spaced 1 centimeter apart will be treated in a simple, interrupted subdermal suture pattern	Device: Vicryl absorbable suture; Vicryl absorbable suture is a synthetic sterile surgical suture made up of a copolymer

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Scar Assessment	The primary endpoint will be the score of two blinded reviewers using the patient observer scar assessment score.	3 months following procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Width of Scar	A secondary endpoint will include the width of the scar 1 cm from midline on each side	3 months following procedure
Erythema	If one half of the scar has more associated erythema, this will be noted	3 months following procedure

Collaborators and Investigators

• Sponsor: University of California, Davis

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 20, 2017
• Primary Completion (ACTUAL): March 2, 2022
• Study Completion (ACTUAL): March 2, 2022

Study Registration Dates

• First Submitted: October 27, 2017
• First Submitted That Met QC Criteria: October 27, 2017
• First Posted (ACTUAL): November 1, 2017

Study Record Updates

• Last Update Posted (ACTUAL): June 7, 2022
• Last Update Submitted That Met QC Criteria: June 6, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: Suture; Wound Closure; Subdermal; Wound Cosmesis
• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID Numbers: 1115591

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes