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5-0 Prolene Versus 5-0 Fast Absorbing Gut

Primary Purpose

Cutaneous Wound

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
5-0 Prolene, 5-0 Fast Absorbing Gut
Sponsored by
University of California, Davis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Cutaneous Wound focused on measuring Suture, Absorbable, Non-absorbable, Split wound, 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

    5-0 Prolene

    5-0 Fast Absorbing Gut

    Arm Description

    Half of the wound will be treated with 5-0 prolene

    Half of the wound will be treated with 5-0 fast absorbing gut

    Outcomes

    Primary Outcome Measures

    Patient Observer Scar Assessment Scale (POSAS)
    The primary endpoint will be the score of two blinded reviewers using the physician observer assessment score at a three-month assessment visit.

    Secondary Outcome Measures

    Width of the scar
    The secondary endpoint will include the width of the scar at the follow-up visit and any complications from the treatment.

    Full Information

    First Posted
    October 2, 2017
    Last Updated
    April 20, 2021
    Sponsor
    University of California, Davis
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03303014
    Brief Title
    5-0 Prolene Versus 5-0 Fast Absorbing Gut
    Official Title
    Use of 5-0 Prolene Versus 5-0 Fast Absorbing Gut During Cutaneous Wound Closure: a Randomized Evaluator Blinded Split Wound Comparative Effectiveness Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2021
    Overall Recruitment Status
    Completed
    Study Start Date
    October 13, 2015 (Actual)
    Primary Completion Date
    March 15, 2016 (Actual)
    Study Completion Date
    October 1, 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

    5. Study Description

    Brief Summary
    When using suture (stitches) to close wounds, surgeons can use suture that is absorbable or non-absorbable. Absorbable sutures naturally break down. Non-absorbable sutures need to be removed. We wish to determine how the cosmetic result of a specific absorbable suture (fast absorbing gut) compares to that of a specific non-absorbable suture (prolene).
    Detailed Description
    The purpose of this study is to determine whether the use of 5-0 prolene during repair of linear cutaneous surgery wounds improves scar cosmesis compared to wound closure with 5-0 fast absorbing gut (both SOC). We will use a split wound model, where half of the wound is treated with 5-0 prolene and the other half is repaired with 5-0 fast absorbing gut. Three-months post-surgery, the scar will be measured via the physician observer scar assessment scale, a validated scar instrument (research procedure). The scar width and adverse events will be recorded. There are many options when it comes to closing a linear cutaneous wound, and an important consideration is choosing between non-absorbable and absorbable sutures. The overall aesthetic superiority between the two is not well understood. Studies to date have typically compared prolene (non-absorbable) and vicryl (absorbable) sutures and found no significant difference in cosmesis.1-4 One study found an increased pain score at 10 days with vicryl, but not at 6 weeks,1 while others have found no difference in pain.2-4 Another study found an increased number of complications with vicryl sutures, including infections and suture granulomas.4 This supports past observations that absorbable sutures can cause more of an immune response and therefore inflammation, despite the benefit of providing more prolonged support to wound edges compared to non-absorbable sutures.1 There is a lack of data, though, comparing prolene to other absorbable sutures, such as fast absorbing gut. In the setting of blepharoplasty, a study found that a running stitch of fast absorbing gut with a simple interrupted stitch of prolene at each end of the incision yielded better cosmetic results and fewer complications than a running stitch or subcuticular stitch using prolene.5 More studies are therefore needed to compare the outcomes of linear closures using only prolene compared to only fast absorbing gut. Using only absorbable sutures has the potential benefit of decreasing healthcare costs by reducing the number of appointments needed for suture removals, and, if superior in terms of cosmesis, corrective procedures.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cutaneous Wound
    Keywords
    Suture, Absorbable, Non-absorbable, Split wound, Cutaneous Wound

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Factorial Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    50 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    5-0 Prolene
    Arm Type
    Experimental
    Arm Description
    Half of the wound will be treated with 5-0 prolene
    Arm Title
    5-0 Fast Absorbing Gut
    Arm Type
    Experimental
    Arm Description
    Half of the wound will be treated with 5-0 fast absorbing gut
    Intervention Type
    Device
    Intervention Name(s)
    5-0 Prolene, 5-0 Fast Absorbing Gut
    Intervention Description
    The interventions are two types of sutures: 5-0 Prolene, 5-0 Fast Absorbing Gut.
    Primary Outcome Measure Information:
    Title
    Patient Observer Scar Assessment Scale (POSAS)
    Description
    The primary endpoint will be the score of two blinded reviewers using the physician observer assessment score at a three-month assessment visit.
    Time Frame
    within 3 months of the procedure
    Secondary Outcome Measure Information:
    Title
    Width of the scar
    Description
    The secondary endpoint will include the width of the scar at the follow-up visit and any complications from the treatment.
    Time Frame
    within 3 months of 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
    270137
    Citation
    Zemla J. [Plastic operation of the alveolar process and associated deformities of the middle part of the face after primary operations for bilateral complete clefts of the lip, alveolar process and palate]. Protet Stomatol. 1977 Mar-Apr;27(2):143-4. No abstract available. Polish.
    Results Reference
    background
    PubMed Identifier
    11281671
    Citation
    Erel E, Pleasance PI, Ahmed O, Hart NB. Absorbable versus non-absorbable suture in carpal tunnel decompression. J Hand Surg Br. 2001 Apr;26(2):157-8. doi: 10.1054/jhsb.2000.0545.
    Results Reference
    background
    PubMed Identifier
    21987279
    Citation
    Theopold C, Potter S, Dempsey M, O'Shaughnessy M. A randomised controlled trial of absorbable versus non-absorbable sutures for skin closure after open carpal tunnel release. J Hand Surg Eur Vol. 2012 May;37(4):350-3. doi: 10.1177/1753193411422334. Epub 2011 Oct 10.
    Results Reference
    background
    PubMed Identifier
    15368623
    Citation
    Menovsky T, Bartels RH, van Lindert EL, Grotenhuis JA. Skin closure in carpal tunnel surgery: a prospective comparative study between nylon, polyglactin 910 and stainless steel sutures. Hand Surg. 2004 Jul;9(1):35-8. doi: 10.1142/s0218810404002017.
    Results Reference
    background
    PubMed Identifier
    17545862
    Citation
    Joshi AS, Janjanin S, Tanna N, Geist C, Lindsey WH. Does suture material and technique really matter? Lessons learned from 800 consecutive blepharoplasties. Laryngoscope. 2007 Jun;117(6):981-4. doi: 10.1097/MLG.0b013e31804f54bd. Erratum In: Laryngoscope. 2007 Aug;117(8):1510. Lindsey, Charlie [corrected to Lindsey, William H].
    Results Reference
    background

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    5-0 Prolene Versus 5-0 Fast Absorbing Gut

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