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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

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.

Condition or disease Intervention/treatment Phase
Interrupted Subdermal Suture Device: Vicryl absorbable 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 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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
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
Official Title: Interrupted Subdermal 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 : September 20, 2017
Estimated Primary Completion Date : August 26, 2019
Estimated Study Completion Date : August 26, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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
Device: Vicryl absorbable suture
Vicryl absorbable suture is a synthetic sterile surgical suture made up of a copolymer

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
Device: Vicryl absorbable suture
Vicryl absorbable suture is a synthetic sterile surgical suture made up of a copolymer




Primary Outcome Measures :
  1. 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.


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

  2. Erythema [ Time Frame: 3 months following procedure ]
    If one half of the scar has more associated erythema, this will be noted



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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): NCT03327922


Contacts
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Contact: Daniel Eisen, MD 916-734-6479 dbeisen@ucdavis.edu
Contact: Simran Dhaliwal, BS 916-734-6556 skdhali@ucdavis.edu

Locations
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United States, California
University of California, Davis, Department of Dermatology Recruiting
Sacramento, California, United States, 95816
Contact: Daniel Eisen, MD    916-734-6479    dbeisen@ucdavis.edu   
Contact: Simran Dhaliwal, BS    (916) 734-6556    skdhali@ucdavis.edu   
Sponsors and Collaborators
University of California, Davis

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Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT03327922     History of Changes
Other Study ID Numbers: 1115591
First Posted: November 1, 2017    Key Record Dates
Last Update Posted: November 19, 2018
Last Verified: November 2018
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
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Keywords provided by University of California, Davis:
Subdermal
Suture
Wound Closure
Wound Cosmesis
Additional relevant MeSH terms:
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Wounds and Injuries