<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/NCT01687972</url>
  </required_header>
  <id_info>
    <org_study_id>NA_00043795</org_study_id>
    <nct_id>NCT01687972</nct_id>
  </id_info>
  <brief_title>INSORB Versus Subcuticular Sutures at Cesarean Section</brief_title>
  <official_title>A Randomized Controlled Trial of Skin Closure at Cesarean Section: INSORB Absorbable Staples Versus Subcuticular Sutures</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Johns Hopkins University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Johns Hopkins University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The proposed study is a randomized controlled trial with two arms. All patients admitted to&#xD;
      Labor and Delivery at Johns Hopkins Hospital for delivery will be approached and offered&#xD;
      entry into our study. Once the patient is enrolled, and if she undergoes a cesarean section,&#xD;
      the patient will be randomized at time of cesarean section to receive skin closure by either&#xD;
      the INSORB™ absorbable staples or subcuticular closure using Biosyn™ suture as is the&#xD;
      standard practice. Both an observer scar assessment score (OSAS) and patient scar assessment&#xD;
      score (PSAS) will be obtained during this visit. The patient will then be contacted by&#xD;
      telephone by a study member 3 months after her surgery for a brief survey (same PSAS survey)&#xD;
      assessing her satisfaction with the resulting scar.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The proposed study is a randomized controlled trial with two arms. All patients admitted to&#xD;
      Labor and Delivery at Johns Hopkins Hospital for delivery will be approached and offered&#xD;
      entry into our study during the routine consent process which includes consent for cesarean&#xD;
      section that occurs with each patient. Once the patient is enrolled, and if she undergoes a&#xD;
      cesarean section, the patient will be randomized at time of cesarean section to receive skin&#xD;
      closure by either the INSORB™ absorbable staples or subcuticular closure using Biosyn™ suture&#xD;
      as is the standard practice. The size of the suture (3-0 vs. 4-0) and type of needle used to&#xD;
      sew is at the discretion of the surgeon. The indications for and performance of the cesarean&#xD;
      section will remain standard care by the Obstetrical team and the patient's participation in&#xD;
      this study will have no impact whatsoever on the obstetrical course of the patient. The only&#xD;
      additional procedure that will be asked of the obstetrical team performing the cesarean&#xD;
      section is to measure and close the subcutaneous tissue if the depth from the skin edge to&#xD;
      the transversalis fascia is greater than 2cm as this has been shown to decrease subsequent&#xD;
      seroma formation and wound disruption. The dressing will be standardized as follows: a folded&#xD;
      abdominal (ABD) pad will be placed in a sterile fashion directly over the incision and foam&#xD;
      tape will be applied to provide a &quot;pressure dressing.&quot; The dressing will be removed on&#xD;
      post-operative day #2.&#xD;
&#xD;
      The patient's postoperative course will remain unchanged and her discharge will be at the&#xD;
      discretion of her obstetrical providers. On post-operative day #3, a picture of the incision&#xD;
      will be taken with the patient's identifying number adjacent to the picture and the patient&#xD;
      will be asked to complete a brief survey asking about post-operative pain and scars (see&#xD;
      included PSAS survey). The patients will follow-up with her Obstetrician for her normal&#xD;
      post-partum visit where another picture of the incision will be taken. Both an observer scar&#xD;
      assessment score (OSAS) and patient scar assessment score (PSAS) will be obtained during this&#xD;
      visit. The patient will then be contacted by telephone by a study member 3 months after her&#xD;
      surgery for a brief survey (same PSAS survey) assessing her satisfaction with the resulting&#xD;
      scar. At this point, the patient's participation in the study will end.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    insufficient recruitment&#xD;
  </why_stopped>
  <start_date type="Actual">September 2011</start_date>
  <completion_date type="Actual">August 2012</completion_date>
  <primary_completion_date type="Actual">August 2012</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Patient Pain Scale</measure>
    <time_frame>3 months</time_frame>
    <description>Visual Analog Score 0-10, with 0 being painless and 10 being the most severe</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Patient Scar Assessment Scale (PSAS)</measure>
    <time_frame>6 weeks</time_frame>
    <description>assessed using the Objective scar scale score, score range 6-60 with 6 being the best score, representing normal skin and 60 being the worst score representing scar very different from the normal skin.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Closure Time</measure>
    <time_frame>up to 20 minutes post intervention</time_frame>
    <description>Number of minutes taken to close post cesarean section</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">187</enrollment>
  <condition>Cesarean Section</condition>
  <condition>Pregnancy</condition>
  <arm_group>
    <arm_group_label>Sutures</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Insorb Staples</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Combination Product</intervention_type>
    <intervention_name>Insorb absorbable staples</intervention_name>
    <description>Placement of Insorb absorbable staples at cesarean section</description>
    <arm_group_label>Insorb Staples</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Combination Product</intervention_type>
    <intervention_name>Absorbable sutures</intervention_name>
    <description>placement of absorbable sutures at cesarean section</description>
    <arm_group_label>Sutures</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  cesarean section via transverse skin incision informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  vertical skin incision&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Johns Hopkins Hospital</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>20794</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Chelmow D, Rodriguez EJ, Sabatini MM. Suture closure of subcutaneous fat and wound disruption after cesarean delivery: a meta-analysis. Obstet Gynecol. 2004 May;103(5 Pt 1):974-80. doi: 10.1097/01.AOG.0000124807.76451.47.</citation>
    <PMID>15121573</PMID>
  </reference>
  <reference>
    <citation>Basha SL, Rochon ML, Quinones JN, Coassolo KM, Rust OA, Smulian JC. Randomized controlled trial of wound complication rates of subcuticular suture vs staples for skin closure at cesarean delivery. Am J Obstet Gynecol. 2010 Sep;203(3):285.e1-8. doi: 10.1016/j.ajog.2010.07.011.</citation>
    <PMID>20816153</PMID>
  </reference>
  <reference>
    <citation>Cromi A, Ghezzi F, Gottardi A, Cherubino M, Uccella S, Valdatta L. Cosmetic outcomes of various skin closure methods following cesarean delivery: a randomized trial. Am J Obstet Gynecol. 2010 Jul;203(1):36.e1-8. doi: 10.1016/j.ajog.2010.02.001. Epub 2010 Apr 24.</citation>
    <PMID>20417924</PMID>
  </reference>
  <reference>
    <citation>Gaertner I, Burkhardt T, Beinder E. Scar appearance of different skin and subcutaneous tissue closure techniques in caesarean section: a randomized study. Eur J Obstet Gynecol Reprod Biol. 2008 May;138(1):29-33. doi: 10.1016/j.ejogrb.2007.07.003. Epub 2007 Sep 6.</citation>
    <PMID>17825472</PMID>
  </reference>
  <reference>
    <citation>Couto RC, Pedrosa TM, Nogueira JM, Gomes DL, Neto MF, Rezende NA. Post-discharge surveillance and infection rates in obstetric patients. Int J Gynaecol Obstet. 1998 Jun;61(3):227-31. doi: 10.1016/s0020-7292(98)00047-2.</citation>
    <PMID>9688482</PMID>
  </reference>
  <reference>
    <citation>Menacker F, Hamilton BE. Recent trends in cesarean delivery in the United States. NCHS Data Brief. 2010 Mar;(35):1-8.</citation>
    <PMID>20334736</PMID>
  </reference>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>September 9, 2012</study_first_submitted>
  <study_first_submitted_qc>September 14, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 19, 2012</study_first_posted>
  <results_first_submitted>March 9, 2017</results_first_submitted>
  <results_first_submitted_qc>August 29, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">April 2, 2018</results_first_posted>
  <last_update_submitted>August 29, 2017</last_update_submitted>
  <last_update_submitted_qc>August 29, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">April 2, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>cesarean section</keyword>
  <keyword>insorb staples</keyword>
  <keyword>absorbable staples</keyword>
  <keyword>transverse skin incision</keyword>

  <clinical_results>

    <participant_flow>
      <recruitment_details>187 were consented, and 88 were randomized to intervention versus placebo.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Sutures</title>
          <description>Absorbable sutures: placement of absorbable sutures at cesarean section</description>
        </group>
        <group group_id="P2">
          <title>Insorb Staples</title>
          <description>Insorb absorbable staples: Placement of Insorb absorbable staples at cesarean section</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="44"/>
                <participants group_id="P2" count="44"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="44"/>
                <participants group_id="P2" count="44"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Sutures</title>
          <description>Absorbable sutures: placement of absorbable sutures at cesarean section</description>
        </group>
        <group group_id="B2">
          <title>Insorb Staples</title>
          <description>Insorb absorbable staples: Placement of Insorb absorbable staples at cesarean section</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="44"/>
            <count group_id="B2" value="44"/>
            <count group_id="B3" value="88"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="44"/>
                    <measurement group_id="B2" value="44"/>
                    <measurement group_id="B3" value="88"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="44"/>
                    <measurement group_id="B2" value="44"/>
                    <measurement group_id="B3" value="88"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="44"/>
                    <measurement group_id="B2" value="44"/>
                    <measurement group_id="B3" value="88"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Patient Pain Scale</title>
        <description>Visual Analog Score 0-10, with 0 being painless and 10 being the most severe</description>
        <time_frame>3 months</time_frame>
        <population>Data was not collected for all participants enrolled due to failure to follow-up post intervention.</population>
        <group_list>
          <group group_id="O1">
            <title>Sutures</title>
            <description>Absorbable sutures: placement of absorbable sutures at cesarean section</description>
          </group>
          <group group_id="O2">
            <title>Insorb Staples</title>
            <description>Insorb absorbable staples: Placement of Insorb absorbable staples at cesarean section</description>
          </group>
        </group_list>
        <measure>
          <title>Patient Pain Scale</title>
          <description>Visual Analog Score 0-10, with 0 being painless and 10 being the most severe</description>
          <population>Data was not collected for all participants enrolled due to failure to follow-up post intervention.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="16"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.375" lower_limit="1" upper_limit="8"/>
                    <measurement group_id="O2" value="3.053" lower_limit="0" upper_limit="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Patient Scar Assessment Scale (PSAS)</title>
        <description>assessed using the Objective scar scale score, score range 6-60 with 6 being the best score, representing normal skin and 60 being the worst score representing scar very different from the normal skin.</description>
        <time_frame>6 weeks</time_frame>
        <population>Data was unable to be collected from all participants randomized due to lack of follow-up post intervention.</population>
        <group_list>
          <group group_id="O1">
            <title>Sutures</title>
            <description>Absorbable sutures: placement of absorbable sutures at cesarean section</description>
          </group>
          <group group_id="O2">
            <title>Insorb Staples</title>
            <description>Insorb absorbable staples: Placement of Insorb absorbable staples at cesarean section</description>
          </group>
        </group_list>
        <measure>
          <title>Patient Scar Assessment Scale (PSAS)</title>
          <description>assessed using the Objective scar scale score, score range 6-60 with 6 being the best score, representing normal skin and 60 being the worst score representing scar very different from the normal skin.</description>
          <population>Data was unable to be collected from all participants randomized due to lack of follow-up post intervention.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
                <count group_id="O2" value="1"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20" lower_limit="11" upper_limit="29"/>
                    <measurement group_id="O2" value="13" lower_limit="13" upper_limit="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Closure Time</title>
        <description>Number of minutes taken to close post cesarean section</description>
        <time_frame>up to 20 minutes post intervention</time_frame>
        <population>Data was not collected for all participants enrolled</population>
        <group_list>
          <group group_id="O1">
            <title>Sutures</title>
            <description>Absorbable sutures: placement of absorbable sutures at cesarean section</description>
          </group>
          <group group_id="O2">
            <title>Insorb Staples</title>
            <description>Insorb absorbable staples: Placement of Insorb absorbable staples at cesarean section</description>
          </group>
        </group_list>
        <measure>
          <title>Closure Time</title>
          <description>Number of minutes taken to close post cesarean section</description>
          <population>Data was not collected for all participants enrolled</population>
          <units>minutes</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="33"/>
                <count group_id="O2" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.161" lower_limit="1" upper_limit="8"/>
                    <measurement group_id="O2" value="9.79" lower_limit="1" upper_limit="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>3 months</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Sutures</title>
          <description>Absorbable sutures: placement of absorbable sutures at cesarean section</description>
        </group>
        <group group_id="E2">
          <title>Insorb Staples</title>
          <description>Insorb absorbable staples: Placement of Insorb absorbable staples at cesarean section</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="44"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="44"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="44"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Janice Henderson, MD Assistant Professor</name_or_title>
      <organization>Johns Hopkins Univesity School of Medicine</organization>
      <phone>443-287-2783</phone>
      <email>jhender7@jhmi.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT01687972
org study id: NA_00043795
nct id: NCT01687972
lead sponsor: 
has dmc: No
The proposed study is a randomized controlled trial with two arms. All patients admitted to
      Labor and Delivery at Johns Hopkins Hospital for delivery will be approached and offered
      entry into our study. Once the patient is enrolled, and if she undergoes a cesarean section,
      the patient will be randomized at time of cesarean section to receive skin closure by either
      the INSORB™ absorbable staples or subcuticular closure using Biosyn™ suture as is the
      standard practice. Both an observer scar assessment score (OSAS) and patient scar assessment
      score (PSAS) will be obtained during this visit. The patient will then be contacted by
      telephone by a study member 3 months after her surgery for a brief survey (same PSAS survey)
      assessing her satisfaction with the resulting scar.
The proposed study is a randomized controlled trial with two arms. All patients admitted to
      Labor and Delivery at Johns Hopkins Hospital for delivery will be approached and offered
      entry into our study during the routine consent process which includes consent for cesarean
      section that occurs with each patient. Once the patient is enrolled, and if she undergoes a
      cesarean section, the patient will be randomized at time of cesarean section to receive skin
      closure by either the INSORB™ absorbable staples or subcuticular closure using Biosyn™ suture
      as is the standard practice. The size of the suture (3-0 vs. 4-0) and type of needle used to
      sew is at the discretion of the surgeon. The indications for and performance of the cesarean
      section will remain standard care by the Obstetrical team and the patient's participation in
      this study will have no impact whatsoever on the obstetrical course of the patient. The only
      additional procedure that will be asked of the obstetrical team performing the cesarean
      section is to measure and close the subcutaneous tissue if the depth from the skin edge to
      the transversalis fascia is greater than 2cm as this has been shown to decrease subsequent
      seroma formation and wound disruption. The dressing will be standardized as follows: a folded
      abdominal (ABD) pad will be placed in a sterile fashion directly over the incision and foam
      tape will be applied to provide a "pressure dressing." The dressing will be removed on
      post-operative day #2.

      The patient's postoperative course will remain unchanged and her discharge will be at the
      discretion of her obstetrical providers. On post-operative day #3, a picture of the incision
      will be taken with the patient's identifying number adjacent to the picture and the patient
      will be asked to complete a brief survey asking about post-operative pain and scars (see
      included PSAS survey). The patients will follow-up with her Obstetrician for her normal
      post-partum visit where another picture of the incision will be taken. Both an observer scar
      assessment score (OSAS) and patient scar assessment score (PSAS) will be obtained during this
      visit. The patient will then be contacted by telephone by a study member 3 months after her
      surgery for a brief survey (same PSAS survey) assessing her satisfaction with the resulting
      scar. At this point, the patient's participation in the study will end.
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: Patient Pain Scale
time frame: 3 months
description: Visual Analog Score 0-10, with 0 being painless and 10 being the most severe
measure: Patient Scar Assessment Scale (PSAS)
time frame: 6 weeks
description: assessed using the Objective scar scale score, score range 6-60 with 6 being the best score, representing normal skin and 60 being the worst score representing scar very different from the normal skin.
measure: Closure Time
time frame: up to 20 minutes post intervention
description: Number of minutes taken to close post cesarean section
arm group label: Sutures
arm group type: Active Comparator
arm group label: Insorb Staples
arm group type: Active Comparator
intervention type: Combination Product
intervention name: Insorb absorbable staples
description: Placement of Insorb absorbable staples at cesarean section
arm group label: Insorb Staples
intervention type: Combination Product
intervention name: Absorbable sutures
description: placement of absorbable sutures at cesarean section
arm group label: Sutures
criteria: 
gender: Female
minimum age: 16 Years
maximum age: 50 Years
healthy volunteers: No
facility: 
country: United States
citation: Chelmow D, Rodriguez EJ, Sabatini MM. Suture closure of subcutaneous fat and wound disruption after cesarean delivery: a meta-analysis. Obstet Gynecol. 2004 May;103(5 Pt 1):974-80. doi: 10.1097/01.AOG.0000124807.76451.47.
PMID: 15121573
citation: Basha SL, Rochon ML, Quinones JN, Coassolo KM, Rust OA, Smulian JC. Randomized controlled trial of wound complication rates of subcuticular suture vs staples for skin closure at cesarean delivery. Am J Obstet Gynecol. 2010 Sep;203(3):285.e1-8. doi: 10.1016/j.ajog.2010.07.011.
PMID: 20816153
citation: Cromi A, Ghezzi F, Gottardi A, Cherubino M, Uccella S, Valdatta L. Cosmetic outcomes of various skin closure methods following cesarean delivery: a randomized trial. Am J Obstet Gynecol. 2010 Jul;203(1):36.e1-8. doi: 10.1016/j.ajog.2010.02.001. Epub 2010 Apr 24.
PMID: 20417924
citation: Gaertner I, Burkhardt T, Beinder E. Scar appearance of different skin and subcutaneous tissue closure techniques in caesarean section: a randomized study. Eur J Obstet Gynecol Reprod Biol. 2008 May;138(1):29-33. doi: 10.1016/j.ejogrb.2007.07.003. Epub 2007 Sep 6.
PMID: 17825472
citation: Couto RC, Pedrosa TM, Nogueira JM, Gomes DL, Neto MF, Rezende NA. Post-discharge surveillance and infection rates in obstetric patients. Int J Gynaecol Obstet. 1998 Jun;61(3):227-31. doi: 10.1016/s0020-7292(98)00047-2.
PMID: 9688482
citation: Menacker F, Hamilton BE. Recent trends in cesarean delivery in the United States. NCHS Data Brief. 2010 Mar;(35):1-8.
PMID: 20334736
responsible party type: Sponsor
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 