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

Overview

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.

Full Title of Study: “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.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Other
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: August 9, 2018

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.

Interventions

  • Device: Fast absorbing gut suture
    • Fast absorbing surgical gut suture is a strand of collagenous material

Arms, Groups and Cohorts

  • 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
  • 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

Clinical Trial Outcome Measures

Primary Measures

  • Patient Posas Score
    • Time Frame: 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 Measures

  • Width of Scar
    • Time Frame: 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
    • Time Frame: 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of California, Davis
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Daniel Eisen, M.D., Principal Investigator, University of California, Davis

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