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

Aesthetic Outcome of Running Cuticular Suture Distance (2mm vs 5mm) From Wound Edge on the Closure of Linear Wounds on the Head and Neck: a Randomized Evaluator Blinded Split Wound Comparative Effective Trial.

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.

Study Overview

• Status: Completed
• Conditions: Cutaneous Sutures and Scar Cosmesis
• Intervention / Treatment: Device: Fast absorbing gut 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 (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.

• 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: Single Group Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Fast absorbing gut suture placed 2 mm apart; Wound closed with sutures spaced 2 millimeters apart will be treated in a simple, interrupted cutaneous suture pattern	Device: Fast absorbing gut suture; Fast absorbing surgical gut suture is a strand of collagenous material
Experimental: Fast absorbing gut suture placed 5 mm apart; Wound closed with sutures spaced 5 millimeters apart will be treated in a simple, interrupted cutaneous suture pattern	Device: Fast absorbing gut suture; Fast absorbing surgical gut suture is a strand of collagenous material

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Posas Score	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.	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. This measurement will be reported in mm	3 months following procedure
Erythema	If one half of the scar has more associated erythema, this will be noted number of people with erythema after treatment will be reported	3 months following procedure

Collaborators and Investigators

• Sponsor: University of California, Davis

Publications and helpful links

General Publications

• Sklar LR, Pourang A, Armstrong AW, Dhaliwal SK, Sivamani RK, Eisen DB. Comparison of Running Cutaneous Suture Spacing During Linear Wound Closures and the Effect on Wound Cosmesis of the Face and Neck: A Randomized Clinical Trial. JAMA Dermatol. 2019 Mar 1;155(3):321-326. doi: 10.1001/jamadermatol.2018.5057.

Study record dates

Study Major Dates

• Study Start (Actual): October 3, 2017
• Primary Completion (Actual): August 9, 2018
• Study Completion (Actual): August 9, 2018

Study Registration Dates

• First Submitted: October 26, 2017
• First Submitted That Met QC Criteria: October 30, 2017
• First Posted (Actual): November 6, 2017

Study Record Updates

• Last Update Posted (Actual): May 12, 2021
• Last Update Submitted That Met QC Criteria: April 20, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: Wound Cosmesis; Cutaneous Sutures; Scar Cosmesis; Linear Wound Closure
• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID Numbers: 1115596

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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