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Running Cutaneous Suture Spacing During Linear Wound Closures and the Effect on Wound Cosmesis

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ClinicalTrials.gov Identifier: NCT03330041
Recruitment Status : Completed
First Posted : November 6, 2017
Results First Posted : January 21, 2020
Last Update Posted : January 21, 2020
Sponsor:
Information provided by (Responsible Party):
University of California, Davis

Tracking Information
First Submitted Date  ICMJE October 26, 2017
First Posted Date  ICMJE November 6, 2017
Results First Submitted Date  ICMJE October 22, 2019
Results First Posted Date  ICMJE January 21, 2020
Last Update Posted Date January 21, 2020
Actual Study Start Date  ICMJE October 3, 2017
Actual Primary Completion Date August 9, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 9, 2020)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: October 30, 2017)
Patient Observer Scar Asessment Score Instrument (POSAS) [ Time Frame: 3 months following procedure ]
Scale name: Patient Observer Scar Assessment Score. Scale measures from 1-10. 10 max 1 min. 1 - scar appears good, 10 - appears cosmetically bad
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 30, 2017)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Running Cutaneous Suture Spacing During Linear Wound Closures and the Effect on Wound Cosmesis
Official Title  ICMJE Running Cutaneous Suture Spacing During Linear Wound Closures and the Effect on Wound Cosmesis: a Randomized Evaluator Blinded Split Wound Comparative Effectiveness Trial
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Intervention Model Description:
At the follow-up visit, two blinded observers will record their scores independently using the physician observer scar assessment score instrument (POSAS).
Masking: Single (Outcomes Assessor)
Primary Purpose: Other
Condition  ICMJE Cutaneous Sutures and Scar Cosmesis
Intervention  ICMJE Device: Fast absorbing gut suture
Fast absorbing surgical gut suture is a strand of collagenous material
Study Arms  ICMJE
  • 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
    Intervention: Device: Fast absorbing gut suture
  • 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
    Intervention: Device: Fast absorbing gut suture
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 30, 2017)
50
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 9, 2018
Actual Primary Completion Date August 9, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03330041
Other Study ID Numbers  ICMJE 1115596
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party University of California, Davis
Study Sponsor  ICMJE University of California, Davis
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of California, Davis
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP