Suturing Distance From the Wound Edge, 2 mm vs 5 mm

Not Applicable

Completed

• Conditions: Cutaneous Sutures and Scar Cosmesis
• Interventions: Device: Fast absorbing gut suture

• Registration Number: NCT03330041
• Lead Sponsor: University of California, Davis

Brief Summary

This study aims to investigate whether the spacing of the interrupted cutaneous sutures affects surgical wound cosmesis on the face and neck. In other words, the investigators would like to determine which of the following yields a more cosmetically appealing scar: many closely approximated sutures or fewer, more widely spaced sutures. The investigators wish to compare the effects of two versus five millimeter 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 (subcutaneous) layer and a top (cutaneous) layer. The deep layer dissolves naturally whereas the top layer may necessitate removal if non-absorbable sutures are used. This study aims to investigate whether the spacing of the interrupted cutaneous sutures affects surgical wound cosmesis on the face and neck. In other words, the investigators would like to determine which of the following yields a more cosmetically appealing scar: many closely approximated sutures or fewer, more widely spaced sutures. The investigators wish to compare the effects of two versus five millimeter 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, the investigators 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 investigators 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: 2017-10-03
• Study First Submitted: 2017-10-26
• Study First Submitted QC: 2017-10-30
• Study First Posted: 2017-11-06
• Primary Completion: 2018-08-09
• Study Completion: 2018-08-09
• Results First Submitted: 2019-10-22
• Results First Submitted QC: 2020-01-09
• Results First Posted: 2020-01-21
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-20
• Last Update Posted: 2021-05-12

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: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Fast absorbing gut suture placed 2 mm apart	Fast absorbing gut suture	Wound closed with sutures spaced 2 millimeters apart will be treated in a simple, interrupted cutaneous suture pattern
Fast absorbing gut suture placed 5 mm apart	Fast absorbing gut suture	Wound closed with sutures spaced 5 millimeters apart will be treated in a simple, interrupted cutaneous suture pattern

Primary Outcome Measures

Name	Time	Method
Patient Posas Score	3 months following procedure	Scale name: Patient Observer Scar Assessment Score. Scale measures six parameters of scars, each using a 10-point scoring system (the six categories are summed to achieve the POSAS score - totals range from 6 to 60), with 1 representing normal skin \& 10 representing the most severe scar imaginable.

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.; This measurement will be reported in mm
Erythema	3 months following procedure	If one half of the scar has more associated erythema, this will be noted number of people with erythema after treatment will be reported

Trial Locations

Locations (1)

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