<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/NCT01724255</url>
  </required_header>
  <id_info>
    <org_study_id>StapleDressingRemoval-HMO-CTIL</org_study_id>
    <nct_id>NCT01724255</nct_id>
  </id_info>
  <brief_title>Optimal Time for Staple/Dressing Removal</brief_title>
  <official_title>The Influence of the Timing of Staple and Dressing Removal After Cesarean Section on the Surgical Incision Healing</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hadassah Medical Organization</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hadassah Medical Organization</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The medical literature does not provide sufficient information or recommendation regarding&#xD;
      the optimal time to remove the staples and the bandage after a cesarean section. The goal of&#xD;
      this study is to compare 5 groups of patients:&#xD;
&#xD;
        1. staple removal on POD 4 and dressing removal on Post Operative Day (POD)1&#xD;
&#xD;
        2. staple removal on POD 4 and dressing removal on Post Operative Day (POD)4&#xD;
&#xD;
        3. staple removal on POD 7 and dressing removal on Post Operative Day (POD)1&#xD;
&#xD;
        4. staple removal on POD 7 and dressing removal on Post Operative Day (POD)7&#xD;
&#xD;
        5. staple removal on POD 4 and dressing removal on Post Operative Day (POD)7&#xD;
&#xD;
      Since there is no definite protocol for staple and dressing removal, we will adapt the above&#xD;
      protocol each for a 3-4 month period of time. Patients will be contacted to either return for&#xD;
      a follow up visit or to answer a telephone survey.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 2013</start_date>
  <completion_date type="Actual">December 2014</completion_date>
  <primary_completion_date type="Actual">October 2014</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of Wound infection and complications</measure>
    <time_frame>6 weeks</time_frame>
  </primary_outcome>
  <number_of_groups>5</number_of_groups>
  <enrollment type="Actual">1500</enrollment>
  <condition>Surgical Wound Healing</condition>
  <condition>Surgical Wound Infection</condition>
  <condition>Patient Satisfaction</condition>
  <arm_group>
    <arm_group_label>staple removal day 4 dressing removal day 1</arm_group_label>
    <description>early staple removal and early dressing removal</description>
  </arm_group>
  <arm_group>
    <arm_group_label>staple removal day 4 dressing removal day 4</arm_group_label>
    <description>early staple removal and day 4 dressing removal</description>
  </arm_group>
  <arm_group>
    <arm_group_label>staple removal day 7, dressing removal day 1</arm_group_label>
    <description>late staple removal and early dressing removal</description>
  </arm_group>
  <arm_group>
    <arm_group_label>staple removal day 7, dressing removal day 7</arm_group_label>
    <description>late staple removal and late dressing removal</description>
  </arm_group>
  <arm_group>
    <arm_group_label>staple removal day 7, dressing removal day 4</arm_group_label>
    <description>late staple removal and day 4 dressing removal</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>questionnaire</intervention_name>
    <arm_group_label>staple removal day 4 dressing removal day 1</arm_group_label>
    <arm_group_label>staple removal day 4 dressing removal day 4</arm_group_label>
    <arm_group_label>staple removal day 7, dressing removal day 1</arm_group_label>
    <arm_group_label>staple removal day 7, dressing removal day 4</arm_group_label>
    <arm_group_label>staple removal day 7, dressing removal day 7</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All patients undergoing a cesarean section at our facility&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients undergoing a cesarean section at our facility&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients lost to follow up&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Drorith Hochner-Celnikier, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hadassah Medical Organization</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hadassah Medical Organization</name>
      <address>
        <city>Jerusalem</city>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>July 2015</verification_date>
  <study_first_submitted>November 7, 2012</study_first_submitted>
  <study_first_submitted_qc>November 7, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 9, 2012</study_first_posted>
  <last_update_submitted>July 26, 2015</last_update_submitted>
  <last_update_submitted_qc>July 26, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 28, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Caesarian section</keyword>
  <keyword>Surgical Wound</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Wound Infection</mesh_term>
    <mesh_term>Surgical Wound Infection</mesh_term>
    <mesh_term>Wounds and Injuries</mesh_term>
    <mesh_term>Surgical Wound</mesh_term>
  </condition_browse>
  <!-- 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/NCT01724255
org study id: StapleDressingRemoval-HMO-CTIL
nct id: NCT01724255
lead sponsor: 
has dmc: No
The medical literature does not provide sufficient information or recommendation regarding
      the optimal time to remove the staples and the bandage after a cesarean section. The goal of
      this study is to compare 5 groups of patients:

        1. staple removal on POD 4 and dressing removal on Post Operative Day (POD)1

        2. staple removal on POD 4 and dressing removal on Post Operative Day (POD)4

        3. staple removal on POD 7 and dressing removal on Post Operative Day (POD)1

        4. staple removal on POD 7 and dressing removal on Post Operative Day (POD)7

        5. staple removal on POD 4 and dressing removal on Post Operative Day (POD)7

      Since there is no definite protocol for staple and dressing removal, we will adapt the above
      protocol each for a 3-4 month period of time. Patients will be contacted to either return for
      a follow up visit or to answer a telephone survey.
observational model: Cohort
time perspective: Prospective
measure: Incidence of Wound infection and complications
time frame: 6 weeks
arm group label: staple removal day 4 dressing removal day 1
description: early staple removal and early dressing removal
arm group label: staple removal day 4 dressing removal day 4
description: early staple removal and day 4 dressing removal
arm group label: staple removal day 7, dressing removal day 1
description: late staple removal and early dressing removal
arm group label: staple removal day 7, dressing removal day 7
description: late staple removal and late dressing removal
arm group label: staple removal day 7, dressing removal day 4
description: late staple removal and day 4 dressing removal
intervention type: Other
intervention name: questionnaire
arm group label: staple removal day 4 dressing removal day 1
arm group label: staple removal day 4 dressing removal day 4
arm group label: staple removal day 7, dressing removal day 1
arm group label: staple removal day 7, dressing removal day 4
arm group label: staple removal day 7, dressing removal day 7
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: Drorith Hochner-Celnikier, MD
role: Principal Investigator
affiliation: Hadassah Medical Organization
facility: 
country: Israel
responsible party type: Sponsor
mesh term: Wound Infection
mesh term: Surgical Wound Infection
mesh term: Wounds and Injuries
mesh term: Surgical Wound