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

Not Applicable

Completed

• Conditions: Interrupted Subdermal Suture
• Interventions: Device: Vicryl absorbable suture

• Registration Number: NCT03327922
• Lead Sponsor: University of California, Davis

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2017-09-20
• Study First Submitted: 2017-10-27
• Study First Submitted QC: 2017-10-27
• Study First Posted: 2017-11-01
• Primary Completion: 2022-03-02
• Study Completion: 2022-03-02
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-06
• Last Update Posted: 2022-06-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Vicryl absorbable suture placed 2 cm apart	Vicryl absorbable suture	Wound closed with sutures spaced 2 centimeters apart will be treated in a simple, interrupted subdermal suture pattern
Vicryl absorbable suture placed 1 cm apart	Vicryl absorbable suture	Wound closed with sutures spaced 1 centimeter apart will be treated in a simple, interrupted subdermal suture pattern

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of California, Davis, Department of Dermatology; 🇺🇸 Sacramento, California, United States