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Interrupted Subdermal Suture Spacing During Linear Wound Closures and the Effect on Wound Cosmesis

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ClinicalTrials.gov Identifier: NCT03327922
Recruitment Status : Recruiting
First Posted : November 1, 2017
Last Update Posted : November 19, 2018
Sponsor:
Information provided by (Responsible Party):
University of California, Davis

Tracking Information
First Submitted Date  ICMJE October 27, 2017
First Posted Date  ICMJE November 1, 2017
Last Update Posted Date November 19, 2018
Actual Study Start Date  ICMJE September 20, 2017
Estimated Primary Completion Date August 26, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 27, 2017)
Scar Assessment [ Time Frame: 3 months following procedure ]
The primary endpoint will be the score of two blinded reviewers using the patient observer scar assessment score.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03327922 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 27, 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
  • Erythema [ Time Frame: 3 months following procedure ]
    If one half of the scar has more associated erythema, this will be noted
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 Interrupted Subdermal Suture Spacing During Linear Wound Closures and the Effect on Wound Cosmesis
Official Title  ICMJE Interrupted Subdermal 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 deep (subdermal) sutures affects surgical wound cosmesis on the trunk and extremities. In other words, the investigator would like to determine which of the following yields a more cosmetically appealing scar: many closely approximated subdermal sutures or fewer, more widely spaced subdermal sutures. The investigator wishes to compare the effects of one versus two centimeter 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 layer and a top layer. The deep layer dissolves naturally whereas the top layer must be removed.

This study aims to investigate whether the spacing of the interrupted deep (subdermal) sutures affects surgical wound cosmesis on the trunk and extremities. In other words, the investigator would like to determine which of the following yields a more cosmetically appealing scar: many closely approximated subdermal sutures or fewer, more widely spaced subdermal sutures. The investigator wishes to compare the effects of one versus two centimeter 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, we 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 investigator 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: Factorial 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 Interrupted Subdermal Suture
Intervention  ICMJE Device: Vicryl absorbable suture
Vicryl absorbable suture is a synthetic sterile surgical suture made up of a copolymer
Study Arms  ICMJE
  • Experimental: Vicryl absorbable suture placed 2 cm apart
    Wound closed with sutures spaced 2 centimeters apart will be treated in a simple, interrupted subdermal suture pattern
    Intervention: Device: Vicryl absorbable suture
  • Experimental: Vicryl absorbable suture placed 1 cm apart
    Wound closed with sutures spaced 1 centimeter apart will be treated in a simple, interrupted subdermal suture pattern
    Intervention: Device: Vicryl absorbable suture
Publications * Not Provided

*   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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 27, 2017)
50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 26, 2019
Estimated Primary Completion Date August 26, 2019   (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: Daniel Eisen, MD 916-734-6479 dbeisen@ucdavis.edu
Contact: Simran Dhaliwal, BS 916-734-6556 skdhali@ucdavis.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03327922
Other Study ID Numbers  ICMJE 1115591
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
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
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 November 2018

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