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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

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.

Condition or disease Intervention/treatment Phase
Cutaneous Sutures and Scar Cosmesis Device: Fast absorbing gut suture Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
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
Official Title: Running Cutaneous Suture Spacing During Linear Wound Closures and the Effect on Wound Cosmesis: a Randomized Evaluator Blinded Split Wound Comparative Effectiveness Trial
Actual Study Start Date : October 3, 2017
Actual Primary Completion Date : August 9, 2018
Actual Study Completion Date : August 9, 2018

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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


  2. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03330041


Locations
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United States, California
University of California, Davis, Department of Dermatology
Sacramento, California, United States, 95816
Sponsors and Collaborators
University of California, Davis
  Study Documents (Full-Text)

Documents provided by University of California, Davis:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT03330041    
Other Study ID Numbers: 1115596
First Posted: November 6, 2017    Key Record Dates
Results First Posted: January 21, 2020
Last Update Posted: January 21, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by University of California, Davis:
Cutaneous Sutures
Scar Cosmesis
Linear Wound Closure
Wound Cosmesis
Additional relevant MeSH terms:
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Wounds and Injuries