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6-0 Fast Absorbing Gut Versus 5-0 Fast Absorbing Gut for Linear Wound Closure

Primary Purpose

Surgical Wound Cosmesis

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
6-0 fast absorbing gut suture
5-0 fast absorbing gut suture
Sponsored by
University of California, Davis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Surgical Wound Cosmesis focused on measuring Cosmesis, Surgical Wound, Fast Absorbing Gut, Linear Cutaneous Wound

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 18 years of age or older
  • Able to give informed consent themselves
  • Patient scheduled for cutaneous surgical procedure on the head and neck 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 3 cm

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    6-0 fast absorbing gut suture

    5-0 fast absorbing gut suture

    Arm Description

    6-0 fast absorbing gut used to suture wound

    5-0 fast absorbing gut used to suture wound

    Outcomes

    Primary Outcome Measures

    Scar Assessment
    The primary endpoint will be the score of two blinded reviewers using the patient observer scar assessment score at a three-month assessment visit.

    Secondary Outcome Measures

    Width of the Scar
    The secondary endpoints will include the width of the scar 1 cm from midline on each side at the follow-up visit and any complications from the treatment.

    Full Information

    First Posted
    October 2, 2017
    Last Updated
    April 29, 2019
    Sponsor
    University of California, Davis
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03303027
    Brief Title
    6-0 Fast Absorbing Gut Versus 5-0 Fast Absorbing Gut for Linear Wound Closure
    Official Title
    Use of 6-0 Fast Absorbing Gut Versus 5-0 Fast Absorbing Gut for Linear Cutaneous Wound Closure: a Randomized Evaluator Blind Split Wound Comparative Effectiveness Trial.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    April 27, 2016 (Actual)
    Primary Completion Date
    March 21, 2017 (Actual)
    Study Completion Date
    April 16, 2019 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of California, Davis

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Traditionally, dermatologic surgeons close wounds with stitches. Fast absorbing gut is a dissolvable stitch that is very commonly used. Some surgeons believe that using a thinner size of this stitch causes less skin reaction and improves the cosmetic outcome of the scar. Other surgeons believe that using a thicker size of this stitch reduces the tension on the scar and improves the cosmetic outcome of the scar in that manner. The investigator wishes to determine whether the thickness of the fast absorbing gut suture that is used makes a difference in the cosmetic outcome of the scar.
    Detailed Description
    The purpose of this study is to determine whether the use of 6-0 fast absorbing gut during repair of linear cutaneous surgery wounds on the face or neck improves scar cosmesis compared to wound closure with 5-0 fast absorbing gut. The investigator will use a split wound model, where half of the wound is repaired with 6-0 fast absorbing gut and the other half is repaired with 5-0 fast absorbing gut. Three-months post-surgery, the scar will be measured via the patient observer scar assessment scale, a validated scar instrument. The scar width, and adverse events will also be recorded. This study aims to investigate whether 5-0 versus 6-0 fast absorbing gut suture leads to better surgical wound cosmesis on the head and neck. The 5-0 fast absorbing gut suture has a large diameter, and therefore greater tensile strength. The greater tensile strength would provide better support of the healing scar during the first 5-7 days after surgery and for this reason, could potentially lead to improved scar cosmesis. However, the greater diameter could also lead to track marks that are larger and more visible. Furthermore, fast absorbing gut has a high degree of tissue reactivity to begin with, and it is known that larger diameter sutures generate more tissue reactivity compared to smaller diameter sutures of the same material; therefore, it is also possible that the 6-0 fast absorbing gut suture would provide better scar cosmesis by virtue of its lower tissue reactivity3,4.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Surgical Wound Cosmesis
    Keywords
    Cosmesis, Surgical Wound, Fast Absorbing Gut, Linear Cutaneous Wound

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Factorial Assignment
    Model Description
    The primary endpoint will be the score of two blinded reviewers using the patient observer scar assessment score at a three-month assessment visit.
    Masking
    Outcomes Assessor
    Allocation
    Non-Randomized
    Enrollment
    50 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    6-0 fast absorbing gut suture
    Arm Type
    Experimental
    Arm Description
    6-0 fast absorbing gut used to suture wound
    Arm Title
    5-0 fast absorbing gut suture
    Arm Type
    Experimental
    Arm Description
    5-0 fast absorbing gut used to suture wound
    Intervention Type
    Device
    Intervention Name(s)
    6-0 fast absorbing gut suture
    Intervention Description
    Fast absorbing surgical gut suture is a strand of collagenous material, size 6-0
    Intervention Type
    Device
    Intervention Name(s)
    5-0 fast absorbing gut suture
    Intervention Description
    Fast absorbing surgical gut suture is a strand of collagenous material, size 5-0
    Primary Outcome Measure Information:
    Title
    Scar Assessment
    Description
    The primary endpoint will be the score of two blinded reviewers using the patient observer scar assessment score at a three-month assessment visit.
    Time Frame
    3 months following the procedure
    Secondary Outcome Measure Information:
    Title
    Width of the Scar
    Description
    The secondary endpoints will include the width of the scar 1 cm from midline on each side at the follow-up visit and any complications from the treatment.
    Time Frame
    3 months following the procedure

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 18 years of age or older Able to give informed consent themselves Patient scheduled for cutaneous surgical procedure on the head and neck 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 3 cm
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Daniel Eisen, MD
    Organizational Affiliation
    University of California, Davis
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Citations:
    PubMed Identifier
    21142740
    Citation
    Tajirian AL, Goldberg DJ. A review of sutures and other skin closure materials. J Cosmet Laser Ther. 2010 Dec;12(6):296-302. doi: 10.3109/14764172.2010.538413.
    Results Reference
    background
    PubMed Identifier
    19465201
    Citation
    Hochberg J, Meyer KM, Marion MD. Suture choice and other methods of skin closure. Surg Clin North Am. 2009 Jun;89(3):627-41. doi: 10.1016/j.suc.2009.03.001.
    Results Reference
    background
    PubMed Identifier
    11176599
    Citation
    Gabrielli F, Potenza C, Puddu P, Sera F, Masini C, Abeni D. Suture materials and other factors associated with tissue reactivity, infection, and wound dehiscence among plastic surgery outpatients. Plast Reconstr Surg. 2001 Jan;107(1):38-45. doi: 10.1097/00006534-200101000-00007.
    Results Reference
    background
    PubMed Identifier
    2543937
    Citation
    van Rijssel EJ, Brand R, Admiraal C, Smit I, Trimbos JB. Tissue reaction and surgical knots: the effect of suture size, knot configuration, and knot volume. Obstet Gynecol. 1989 Jul;74(1):64-8.
    Results Reference
    background

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    6-0 Fast Absorbing Gut Versus 5-0 Fast Absorbing Gut for Linear Wound Closure

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