<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/NCT03001856</url>
  </required_header>
  <id_info>
    <org_study_id>MaeFahLuangUH</org_study_id>
    <nct_id>NCT03001856</nct_id>
  </id_info>
  <brief_title>Interrupted Oblique Intradermal Suture Versus Conventional Interrupted Intradermal Suture</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mae Fah Luang University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mae Fah Luang University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study was conducted to demonstrate the equivalence of wound outcomes between the&#xD;
      interrupted oblique intradermal suture (OIS) and conventional interrupted intradermal suture&#xD;
      (IS) methods&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Bi-layered skin closure is one of the most common methods for closing cutaneous defects. The&#xD;
      deep layer is closed with a conventional interrupted intradermal suture using absorbable&#xD;
      materials, while the superficial layer is approximated with simple interrupted or simple&#xD;
      continuous suture using non-absorbable materials. The cosmetic result of bi-layered closure&#xD;
      is better than simple interrupted suture alone, because the interrupted intradermal suture&#xD;
      component plays a major role in reducing wound tension, which has the effect of minimizing&#xD;
      suture marks. Although the advantages of bi-layered closure are recognized, bi-layered&#xD;
      closure is often not used in favor of simple interrupted suture due to the fact that&#xD;
      interrupted intradermal suture is time consuming and more suture material is required. Thus,&#xD;
      if an intradermal suturing technique can be identified that takes less time and requires less&#xD;
      material while yielding a similar cosmetic result, patients would have more opportunity to&#xD;
      receive bi-layered closure and obtain a better wound outcome.&#xD;
&#xD;
      Several novel intradermal suturing techniques could be alternative to the conventional&#xD;
      interrupted intradermal suture technique, including buried butterfly suture, double butterfly&#xD;
      suture, subcutaneous inverted cross mattress suture, and interrupted oblique intradermal&#xD;
      suture. Among these novel techniques, interrupted oblique intradermal suture (OIS) is&#xD;
      recognized for its relative simplicity. OIS is easy to perform, even for beginners. The&#xD;
      simplicity and effectiveness of OIS increase its potential of becoming one of the standard&#xD;
      suturing techniques in medical practice.&#xD;
&#xD;
      OIS is very similar to conventional interrupted intradermal suture (IS), except that the&#xD;
      suture in OIS is canted or angled relative to the vertical plane. To perform OIS, the needle&#xD;
      is passed from deep to superficial dermis and canted 30°-60° from the normal vertical plane.&#xD;
      The needle is then inserted into the opposite wound edge from superficial to deep dermis in a&#xD;
      mirror-image fashion. The thread is tied with a square knot to finish the suture. The key&#xD;
      characteristic that distinguishes OIS from IS is that OIS involves suturing on an angle to&#xD;
      the vertical plane and IS involves suturing on the vertical plane.&#xD;
&#xD;
      In theory, OIS is a hybrid method that combines IS and buried horizontal butterfly suture.&#xD;
      OIS combines the ability of IS to reduce tension at the wound edge and the ability of&#xD;
      horizontal butterfly suture to provide good wound edge apposition and eversion. Because OIS&#xD;
      is canted, it can provide tension in both the vertical and horizontal planes. Moreover, 1&#xD;
      stitch of OIS should yield wound closure approximately equal to that of 2 stitches of IS due&#xD;
      to the same horizontal distance between 1 OIS stitch and 2 VIS stitches. Accordingly, it can&#xD;
      be inferred that OIS should result in a 50% reduction in both suturing time and suturing&#xD;
      material used.&#xD;
&#xD;
      However, OIS has the same obstacle as many other novel suturing techniques that there is very&#xD;
      little literature to support OIS clinically which makes usage and generalization of TIS&#xD;
      remain limited. It was hypothesized that OIS is equivalence to IS in wound outcome while&#xD;
      consumes less time and less suture material. This study aims to demonstrate the equivalence&#xD;
      of wound outcomes between the interrupted oblique intradermal suture (OIS) and conventional&#xD;
      interrupted intradermal suture (IS) methods.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2016</start_date>
  <completion_date type="Actual">December 2016</completion_date>
  <primary_completion_date type="Actual">December 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>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Modified Hollander Cosmesis Scale (MHCS) at 1st week</measure>
    <time_frame>1 week</time_frame>
    <description>Wound evaluation at 1st week</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Patient and Observer Scar Assessment Scale (POSAS) at 1st week</measure>
    <time_frame>1 week</time_frame>
    <description>Wound evaluation at 1st week</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Modified Hollander Cosmesis Scale (MHCS) at 2nd month</measure>
    <time_frame>2nd month</time_frame>
    <description>Wound evaluation at 2nd month</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Patient and Observer Scar Assessment Scale (POSAS) at 2nd month</measure>
    <time_frame>2nd month</time_frame>
    <description>Wound evaluation at 2nd month</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Rate of wound dehiscence</measure>
    <time_frame>1 week</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of wound infection</measure>
    <time_frame>1 week</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Suture time</measure>
    <time_frame>day 1</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of stitches</measure>
    <time_frame>day 1</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Suture material length</measure>
    <time_frame>day 1</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">144</enrollment>
  <condition>Surgery</condition>
  <arm_group>
    <arm_group_label>Oblique Intradermal Suture</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>OIS is very similar to conventional interrupted intradermal suture (IS), except that the suture in OIS is canted or angled relative to the vertical plane (Figure 1). To perform OIS, the needle is passed from deep to superficial dermis and canted 30°-60° from the normal vertical plane. The needle is then inserted into the opposite wound edge from superficial to deep dermis in a mirror-image fashion. The thread is tied with a square knot to finish the suture.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intradermal Suture</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Conventional interrupted intradermal suture</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Oblique Intradermal Suture</intervention_name>
    <arm_group_label>Oblique Intradermal Suture</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Intradermal Suture</intervention_name>
    <arm_group_label>Intradermal Suture</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 years or older&#xD;
&#xD;
          -  needs elective surgery with linear incision wound&#xD;
&#xD;
          -  wound length must be 3-12 cm.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  irregular wound shape&#xD;
&#xD;
          -  asymmetrical wound depth&#xD;
&#xD;
          -  different skin color in wound area&#xD;
&#xD;
          -  contaminated wound&#xD;
&#xD;
          -  mental impairment&#xD;
&#xD;
          -  pregnancy&#xD;
&#xD;
          -  patients with soft tissue disease&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>December 19, 2016</study_first_submitted>
  <study_first_submitted_qc>December 22, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 23, 2016</study_first_posted>
  <last_update_submitted>January 8, 2017</last_update_submitted>
  <last_update_submitted_qc>January 8, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 10, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mae Fah Luang University Hospital</investigator_affiliation>
    <investigator_full_name>Apinut Wongkietkachorn</investigator_full_name>
    <investigator_title>Doctor</investigator_title>
  </responsible_party>
  <!-- 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/NCT03001856
org study id: MaeFahLuangUH
nct id: NCT03001856
lead sponsor: 
has dmc: No
This study was conducted to demonstrate the equivalence of wound outcomes between the
      interrupted oblique intradermal suture (OIS) and conventional interrupted intradermal suture
      (IS) methods
Bi-layered skin closure is one of the most common methods for closing cutaneous defects. The
      deep layer is closed with a conventional interrupted intradermal suture using absorbable
      materials, while the superficial layer is approximated with simple interrupted or simple
      continuous suture using non-absorbable materials. The cosmetic result of bi-layered closure
      is better than simple interrupted suture alone, because the interrupted intradermal suture
      component plays a major role in reducing wound tension, which has the effect of minimizing
      suture marks. Although the advantages of bi-layered closure are recognized, bi-layered
      closure is often not used in favor of simple interrupted suture due to the fact that
      interrupted intradermal suture is time consuming and more suture material is required. Thus,
      if an intradermal suturing technique can be identified that takes less time and requires less
      material while yielding a similar cosmetic result, patients would have more opportunity to
      receive bi-layered closure and obtain a better wound outcome.

      Several novel intradermal suturing techniques could be alternative to the conventional
      interrupted intradermal suture technique, including buried butterfly suture, double butterfly
      suture, subcutaneous inverted cross mattress suture, and interrupted oblique intradermal
      suture. Among these novel techniques, interrupted oblique intradermal suture (OIS) is
      recognized for its relative simplicity. OIS is easy to perform, even for beginners. The
      simplicity and effectiveness of OIS increase its potential of becoming one of the standard
      suturing techniques in medical practice.

      OIS is very similar to conventional interrupted intradermal suture (IS), except that the
      suture in OIS is canted or angled relative to the vertical plane. To perform OIS, the needle
      is passed from deep to superficial dermis and canted 30°-60° from the normal vertical plane.
      The needle is then inserted into the opposite wound edge from superficial to deep dermis in a
      mirror-image fashion. The thread is tied with a square knot to finish the suture. The key
      characteristic that distinguishes OIS from IS is that OIS involves suturing on an angle to
      the vertical plane and IS involves suturing on the vertical plane.

      In theory, OIS is a hybrid method that combines IS and buried horizontal butterfly suture.
      OIS combines the ability of IS to reduce tension at the wound edge and the ability of
      horizontal butterfly suture to provide good wound edge apposition and eversion. Because OIS
      is canted, it can provide tension in both the vertical and horizontal planes. Moreover, 1
      stitch of OIS should yield wound closure approximately equal to that of 2 stitches of IS due
      to the same horizontal distance between 1 OIS stitch and 2 VIS stitches. Accordingly, it can
      be inferred that OIS should result in a 50% reduction in both suturing time and suturing
      material used.

      However, OIS has the same obstacle as many other novel suturing techniques that there is very
      little literature to support OIS clinically which makes usage and generalization of TIS
      remain limited. It was hypothesized that OIS is equivalence to IS in wound outcome while
      consumes less time and less suture material. This study aims to demonstrate the equivalence
      of wound outcomes between the interrupted oblique intradermal suture (OIS) and conventional
      interrupted intradermal suture (IS) methods.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Modified Hollander Cosmesis Scale (MHCS) at 1st week
time frame: 1 week
description: Wound evaluation at 1st week
measure: Patient and Observer Scar Assessment Scale (POSAS) at 1st week
time frame: 1 week
description: Wound evaluation at 1st week
measure: Modified Hollander Cosmesis Scale (MHCS) at 2nd month
time frame: 2nd month
description: Wound evaluation at 2nd month
measure: Patient and Observer Scar Assessment Scale (POSAS) at 2nd month
time frame: 2nd month
description: Wound evaluation at 2nd month
measure: Rate of wound dehiscence
time frame: 1 week
measure: Rate of wound infection
time frame: 1 week
measure: Suture time
time frame: day 1
measure: Number of stitches
time frame: day 1
measure: Suture material length
time frame: day 1
arm group label: Oblique Intradermal Suture
arm group type: Experimental
description: OIS is very similar to conventional interrupted intradermal suture (IS), except that the suture in OIS is canted or angled relative to the vertical plane (Figure 1). To perform OIS, the needle is passed from deep to superficial dermis and canted 30°-60° from the normal vertical plane. The needle is then inserted into the opposite wound edge from superficial to deep dermis in a mirror-image fashion. The thread is tied with a square knot to finish the suture.
arm group label: Intradermal Suture
arm group type: Experimental
description: Conventional interrupted intradermal suture
intervention type: Procedure
intervention name: Oblique Intradermal Suture
arm group label: Oblique Intradermal Suture
intervention type: Procedure
intervention name: Intradermal Suture
arm group label: Intradermal Suture
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Principal Investigator
investigator affiliation: Mae Fah Luang University Hospital
investigator full name: Apinut Wongkietkachorn
investigator title: Doctor