<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03303014</url>
  </required_header>
  <id_info>
    <org_study_id>811023</org_study_id>
    <nct_id>NCT03303014</nct_id>
    <nct_alias>NCT02991755</nct_alias>
  </id_info>
  <brief_title>5-0 Prolene Versus 5-0 Fast Absorbing Gut</brief_title>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, Davis</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of California, Davis</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      When using suture (stitches) to close wounds, surgeons can use suture that is absorbable or&#xD;
      non-absorbable. Absorbable sutures naturally break down. Non-absorbable sutures need to be&#xD;
      removed. We wish to determine how the cosmetic result of a specific absorbable suture (fast&#xD;
      absorbing gut) compares to that of a specific non-absorbable suture (prolene).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this study is to determine whether the use of 5-0 prolene during repair of&#xD;
      linear cutaneous surgery wounds improves scar cosmesis compared to wound closure with 5-0&#xD;
      fast absorbing gut (both SOC). We will use a split wound model, where half of the wound is&#xD;
      treated with 5-0 prolene and the other half is repaired with 5-0 fast absorbing gut.&#xD;
      Three-months post-surgery, the scar will be measured via the physician observer scar&#xD;
      assessment scale, a validated scar instrument (research procedure). The scar width and&#xD;
      adverse events will be recorded.&#xD;
&#xD;
      There are many options when it comes to closing a linear cutaneous wound, and an important&#xD;
      consideration is choosing between non-absorbable and absorbable sutures. The overall&#xD;
      aesthetic superiority between the two is not well understood. Studies to date have typically&#xD;
      compared prolene (non-absorbable) and vicryl (absorbable) sutures and found no significant&#xD;
      difference in cosmesis.1-4 One study found an increased pain score at 10 days with vicryl,&#xD;
      but not at 6 weeks,1 while others have found no difference in pain.2-4 Another study found an&#xD;
      increased number of complications with vicryl sutures, including infections and suture&#xD;
      granulomas.4 This supports past observations that absorbable sutures can cause more of an&#xD;
      immune response and therefore inflammation, despite the benefit of providing more prolonged&#xD;
      support to wound edges compared to non-absorbable sutures.1&#xD;
&#xD;
      There is a lack of data, though, comparing prolene to other absorbable sutures, such as fast&#xD;
      absorbing gut. In the setting of blepharoplasty, a study found that a running stitch of fast&#xD;
      absorbing gut with a simple interrupted stitch of prolene at each end of the incision yielded&#xD;
      better cosmetic results and fewer complications than a running stitch or subcuticular stitch&#xD;
      using prolene.5 More studies are therefore needed to compare the outcomes of linear closures&#xD;
      using only prolene compared to only fast absorbing gut. Using only absorbable sutures has the&#xD;
      potential benefit of decreasing healthcare costs by reducing the number of appointments&#xD;
      needed for suture removals, and, if superior in terms of cosmesis, corrective procedures.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 13, 2015</start_date>
  <completion_date type="Actual">October 1, 2019</completion_date>
  <primary_completion_date type="Actual">March 15, 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Factorial Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Patient Observer Scar Assessment Scale (POSAS)</measure>
    <time_frame>within 3 months of the procedure</time_frame>
    <description>The primary endpoint will be the score of two blinded reviewers using the physician observer assessment score at a three-month assessment visit.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Width of the scar</measure>
    <time_frame>within 3 months of the procedure</time_frame>
    <description>The secondary endpoint will include the width of the scar at the follow-up visit and any complications from the treatment.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Cutaneous Wound</condition>
  <arm_group>
    <arm_group_label>5-0 Prolene</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Half of the wound will be treated with 5-0 prolene</description>
  </arm_group>
  <arm_group>
    <arm_group_label>5-0 Fast Absorbing Gut</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Half of the wound will be treated with 5-0 fast absorbing gut</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>5-0 Prolene, 5-0 Fast Absorbing Gut</intervention_name>
    <description>The interventions are two types of sutures: 5-0 Prolene, 5-0 Fast Absorbing Gut.</description>
    <arm_group_label>5-0 Fast Absorbing Gut</arm_group_label>
    <arm_group_label>5-0 Prolene</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 years of age or older&#xD;
&#xD;
          -  Able to give informed consent themselves&#xD;
&#xD;
          -  Patient scheduled for cutaneous surgical procedure on the head and neck with predicted&#xD;
             primary closure&#xD;
&#xD;
          -  Willing to return for follow up visit.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Mentally handicapped&#xD;
&#xD;
          -  Unable to understand written and oral English&#xD;
&#xD;
          -  Incarceration&#xD;
&#xD;
          -  Under 18 years of age&#xD;
&#xD;
          -  Pregnant Women&#xD;
&#xD;
          -  Wounds with predicted closure length less than 3 cm&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Daniel Eisen, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of California, Davis</affiliation>
  </overall_official>
  <reference>
    <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.</citation>
    <PMID>270137</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>11281671</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>21987279</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>15368623</PMID>
  </reference>
  <reference>
    <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].</citation>
    <PMID>17545862</PMID>
  </reference>
  <verification_date>April 2021</verification_date>
  <study_first_submitted>October 2, 2017</study_first_submitted>
  <study_first_submitted_qc>October 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 5, 2017</study_first_posted>
  <last_update_submitted>April 20, 2021</last_update_submitted>
  <last_update_submitted_qc>April 20, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 22, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Suture</keyword>
  <keyword>Absorbable</keyword>
  <keyword>Non-absorbable</keyword>
  <keyword>Split wound</keyword>
  <keyword>Cutaneous Wound</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Wounds and Injuries</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03303014
org study id: 811023
nct id: NCT03303014
nct alias: NCT02991755
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
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).
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.
allocation: Randomized
intervention model: Factorial Assignment
primary purpose: Other
masking: Single (Outcomes Assessor)
measure: Patient Observer Scar Assessment Scale (POSAS)
time frame: within 3 months of the procedure
description: The primary endpoint will be the score of two blinded reviewers using the physician observer assessment score at a three-month assessment visit.
measure: Width of the scar
time frame: within 3 months of the procedure
description: The secondary endpoint will include the width of the scar at the follow-up visit and any complications from the treatment.
arm group label: 5-0 Prolene
arm group type: Experimental
description: Half of the wound will be treated with 5-0 prolene
arm group label: 5-0 Fast Absorbing Gut
arm group type: Experimental
description: Half of the wound will be treated with 5-0 fast absorbing gut
intervention type: Device
intervention name: 5-0 Prolene, 5-0 Fast Absorbing Gut
description: The interventions are two types of sutures: 5-0 Prolene, 5-0 Fast Absorbing Gut.
arm group label: 5-0 Fast Absorbing Gut
arm group label: 5-0 Prolene
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Daniel Eisen, MD
role: Principal Investigator
affiliation: University of California, Davis
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.
PMID: 270137
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.
PMID: 11281671
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.
PMID: 21987279
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.
PMID: 15368623
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].
PMID: 17545862
responsible party type: Sponsor
mesh term: Wounds and Injuries
sharing ipd: Undecided