<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/NCT01697748</url>
  </required_header>
  <id_info>
    <org_study_id>USF IRB 00008650</org_study_id>
    <nct_id>NCT01697748</nct_id>
    <nct_alias>NCT01927211</nct_alias>
  </id_info>
  <brief_title>Prospective Study on Cesarean Wound Outcomes</brief_title>
  <official_title>A Prospective Randomized Study Assessing Post Operative Wound Infections Along With Cosmetic Outcomes Using Silver Impregnated Dressings Compared to Conventional Dressings on Cesarean Section Incisions</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of South Florida</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of South Florida</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will investigate whether the placement of silver impregnated dressings beginning&#xD;
      in the OR will improve wound healing in patients undergoing cesarean delivery compared to&#xD;
      traditional Telfa pads. This study will also explore the presumed improvement in scar&#xD;
      integrity when silver impregnated dressings are used compared to the Telfa pads.&#xD;
&#xD;
      The study will compare the percentage of patients who develop a surgical site infection after&#xD;
      application of silver impregnated dressings versus standard Telfa dressings. Investigators&#xD;
      will also assess the cosmetic appearance and pain of the cesarean section scar at the&#xD;
      patient's one week and 6 week post-operative visits.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a randomized, prospective study involving 660 patients undergoing cesarean sections&#xD;
      at Tampa General Hospital. The control group (n=330) will receive standard Telfa pad dressing&#xD;
      and the treatment group (n=330) will receive the silver impregnated dressing.&#xD;
&#xD;
      The primary objective is to compare the percentage of patients who develop a surgical site&#xD;
      infection between the two groups at the 1-week and 6-weeks post operative visits. The&#xD;
      secondary objective is to assess the cosmetic outcome of the cesarean incision observed at&#xD;
      the 1-week and 6-week post-operative visits. A plastic surgery investigator will also conduct&#xD;
      a blinded assessment of cosmetic outcome by review of photographs taken of the wounds at&#xD;
      1-week and 6-weeks.The tertiary objective is to evaluate the amount of narcotic and non&#xD;
      narcotic medicine consumed during the hospitalization and query the patient with regards to&#xD;
      pain involving the cesarean wound at 1 and 6 week post-operative visits&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2013</start_date>
  <completion_date type="Actual">May 2018</completion_date>
  <primary_completion_date type="Actual">August 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>Prevention</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Patients Who Develop a Surgical Site Infection</measure>
    <time_frame>from post operative day #1 through post operative day 30</time_frame>
    <description>A surgical site infection involving the skin and subcutaneous tissue is defined as either&#xD;
The presence of a purulent discharge from the wound on inspection, or&#xD;
Purulent discharge obtained from the wound after exploration based on the suspicion of the provider (erythema, swelling, heat or pain), or&#xD;
The presence of a seroma or hematoma discharge from the wound on inspection or after exploration that also involves isolation of an organism from an aseptically obtained culture based on suspicion of the provider (erythema, swelling, heat or pain). Seromas or hematomas with negative cultures will not be considered a surgical site infection.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cosmetic Outcome of the Cesarean Section Incision</measure>
    <time_frame>Post operative day 7</time_frame>
    <description>The following instruments will be used to determine the cosmetic outcome:&#xD;
• The Modified Vancouver scar scale Range of scale values are from 0-12 (0 indicating a better outcome)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cosmetic Outcome of the Cesarean Section Incision</measure>
    <time_frame>Six weeks post-operative</time_frame>
    <description>The following instruments will be used to determine the cosmetic outcome&#xD;
• The Modified Observer Scar Assessment Scale Range of scale values is from 5 - 50 ( the lower the score the better the outcome)</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Reduction of Pain After Cesarean Delivery</measure>
    <time_frame>Immediately post operatively to hospital discharge</time_frame>
    <description>The amount of narcotics measured in Morphine equivalent milligrams and non opioids administered during the cesarean delivery hospitalization were recorded</description>
  </other_outcome>
  <other_outcome>
    <measure>The Number of Participants Noting Pain at the One Week Post Cesarean Visit</measure>
    <time_frame>Post operative day 7</time_frame>
    <description>Pain response to notable pain at wound site during 7 day post operative visit Subjective self reporting pain as yes or no.</description>
  </other_outcome>
  <other_outcome>
    <measure>The Number of Participants Noting Pain at the Six Weeks Post Cesarean Visit</measure>
    <time_frame>6 weeks post operative</time_frame>
    <description>Pain response to notable pain at wound site during 6 week post operative visit Subjective self reporting of pain as yes or no.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">660</enrollment>
  <condition>Surgical Site Infection</condition>
  <condition>Cosmetic Appearance of Cesarean Scar</condition>
  <condition>Post Operative Pain</condition>
  <arm_group>
    <arm_group_label>Telfa pad dressing</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Telfa pad dressing placed over Cesarean wound after skin closure; the dressing will be changed to a new Telfa pad dressing on post-operative day 2 which will remain on the incision through post-operative day 7.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Silver-impregnated dressing</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Silver-impregnated dressing placed over Cesarean wound after skin closure; the dressing will be changed to saline-treated dressing on post-operative day 2 which will remain on the incision through post-operative day 7.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Silver-impregnated dressing</intervention_name>
    <description>Silver-impregnated dressing placed over Cesarean wound after skin closure; the dressing will be changed to saline-treated dressing on post-operative day 2 which will remain on the incision through post-operative day 7.</description>
    <arm_group_label>Silver-impregnated dressing</arm_group_label>
    <other_name>Silverlon</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Telfa pad dressing</intervention_name>
    <description>Telfa pad dressing placed over Cesarean wound after skin closure; the dressing will be changed to a new Telfa pad dressing on post-operative day 2 which will remain on the incision through post-operative day 7.</description>
    <arm_group_label>Telfa pad dressing</arm_group_label>
    <other_name>Telfa pad</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 18 or older&#xD;
&#xD;
          -  Elective and emergent cesarean deliveries&#xD;
&#xD;
          -  Primary and repeat cesarean sections&#xD;
&#xD;
          -  Transverse skin incisions (Pfannenstiel)&#xD;
&#xD;
          -  Low transverse uterine incisions&#xD;
&#xD;
          -  Patients with or without the diagnosis of chorioamnionitis with antibiotic treatment&#xD;
             prior to or after the delivery of the baby&#xD;
&#xD;
          -  Single and multiple gestations&#xD;
&#xD;
          -  Able and willing to provide written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients that did not receive routine prophylactic dose of antibiotics in the&#xD;
             operating room.&#xD;
&#xD;
          -  Skin incisions other than Pfannenstiel&#xD;
&#xD;
          -  Uterine incisions other than low transverse&#xD;
&#xD;
          -  Patients with known or discovered allergy to silver or nylon&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sheila Connery, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>USF Health Morsani College of Medicine, Department of Obstetrics and Gynecology</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>USF Health South Tampa Center for Advanced Healthcare</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33606</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Women's Center Operating Rooms at the Tampa General Hospital</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33606</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>USF Health Morsani Center for Advanced Healthcare</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Opoien HK, Valbo A, Grinde-Andersen A, Walberg M. Post-cesarean surgical site infections according to CDC standards: rates and risk factors. A prospective cohort study. Acta Obstet Gynecol Scand. 2007;86(9):1097-102. doi: 10.1080/00016340701515225.</citation>
    <PMID>17712651</PMID>
  </reference>
  <reference>
    <citation>Owens SM, Brozanski BS, Meyn LA, Wiesenfeld HC. Antimicrobial prophylaxis for cesarean delivery before skin incision. Obstet Gynecol. 2009 Sep;114(3):573-579. doi: 10.1097/AOG.0b013e3181b490f1.</citation>
    <PMID>19701037</PMID>
  </reference>
  <reference>
    <citation>Olsen MA, Butler AM, Willers DM, Devkota P, Gross GA, Fraser VJ. Risk factors for surgical site infection after low transverse cesarean section. Infect Control Hosp Epidemiol. 2008 Jun;29(6):477-84; discussion 485-6. doi: 10.1086/587810.</citation>
    <PMID>18510455</PMID>
  </reference>
  <reference>
    <citation>Epstein NE. Do silver-impregnated dressings limit infections after lumbar laminectomy with instrumented fusion? Surg Neurol. 2007 Nov;68(5):483-5; discussion 485. doi: 10.1016/j.surneu.2007.05.045.</citation>
    <PMID>17961738</PMID>
  </reference>
  <reference>
    <citation>Perkins James, Pattillo Rolandid. How to Avert Postoperative Wound Complications-Treat It when It Occurs. OBG Management 2009;21(10):43-53.</citation>
  </reference>
  <reference>
    <citation>Huckfeldt R, Redmond C, Mikkelson D, Finley PJ, Lowe C, Robertson J. A clinical trial to investigate the effect of silver nylon dressings on mediastinitis rates in postoperative cardiac sternotomy incisions. Ostomy Wound Manage. 2008 Oct;54(10):36-41.</citation>
    <PMID>18927482</PMID>
  </reference>
  <reference>
    <citation>Leaper DJ. Silver dressings: their role in wound management. Int Wound J. 2006 Dec;3(4):282-94. doi: 10.1111/j.1742-481X.2006.00265.x.</citation>
    <PMID>17199764</PMID>
  </reference>
  <reference>
    <citation>Mustoe TA, Cooter RD, Gold MH, Hobbs FD, Ramelet AA, Shakespeare PG, Stella M, Teot L, Wood FM, Ziegler UE; International Advisory Panel on Scar Management. International clinical recommendations on scar management. Plast Reconstr Surg. 2002 Aug;110(2):560-71. doi: 10.1097/00006534-200208000-00031.</citation>
    <PMID>12142678</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>Draaijers LJ, Tempelman FR, Botman YA, Tuinebreijer WE, Middelkoop E, Kreis RW, van Zuijlen PP. The patient and observer scar assessment scale: a reliable and feasible tool for scar evaluation. Plast Reconstr Surg. 2004 Jun;113(7):1960-5; discussion 1966-7. doi: 10.1097/01.prs.0000122207.28773.56.</citation>
    <PMID>15253184</PMID>
  </reference>
  <reference>
    <citation>Thomas Steve. MRSA and the Use of Silver Dressings: Overcoming Bacterial Resistance. http://www.worldwidewounds.com/2004/november/Thomas/Introducing-Silver Dressings.html.</citation>
  </reference>
  <reference>
    <citation>Yiannias, James. Clinical features and diagnosis of allergic contact dermatitis. http://www.uptodate.com/contents/clinical-features-and-diagnosis-of-allergic-contact-dermatitis</citation>
  </reference>
  <verification_date>December 2012</verification_date>
  <study_first_submitted>September 19, 2012</study_first_submitted>
  <study_first_submitted_qc>September 27, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 2, 2012</study_first_posted>
  <results_first_submitted>August 6, 2018</results_first_submitted>
  <results_first_submitted_qc>August 27, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">September 26, 2018</results_first_posted>
  <last_update_submitted>October 25, 2019</last_update_submitted>
  <last_update_submitted_qc>October 25, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">November 14, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>cesarean section incisions</keyword>
  <keyword>silver</keyword>
  <keyword>c-section</keyword>
  <keyword>wound infection</keyword>
  <keyword>scar appearance</keyword>
  <keyword>post operative pain</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</mesh_term>
    <mesh_term>Surgical Wound Infection</mesh_term>
    <mesh_term>Wound Infection</mesh_term>
    <mesh_term>Pain, Postoperative</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Recruitment was from September 2013 through June 2016. The 6 week post operative visits were completed August 2016.&#xD;
Recruitment was at University of South Florida South Tampa Campus, Tampa General Hospital Healthpark Genesis and Tampa General Hospital Tampa Florida Labor and Delivery Triage.</recruitment_details>
      <pre_assignment_details>3 patients were inadequately consented, two in the Silverlon dressing group and one in the Telfa dressing group</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Telfa Pad Dressing</title>
          <description>Telfa pad dressing placed over Cesarean wound after skin closure; the dressing will be changed to a new Telfa pad dressing on post-operative day 2 which will remain on the incision through post-operative day 7.&#xD;
Telfa pad dressing: Telfa pad dressing placed over Cesarean wound after skin closure; the dressing will be changed to a new Telfa pad dressing on post-operative day 2 which will remain on the incision through post-operative day 7.</description>
        </group>
        <group group_id="P2">
          <title>Silver-impregnated Dressing</title>
          <description>Silver-impregnated dressing placed over Cesarean wound after skin closure; the dressing will be changed to saline-treated dressing on post-operative day 2 which will remain on the incision through post-operative day 7.&#xD;
Silver-impregnated dressing: Silver-impregnated dressing placed over Cesarean wound after skin closure; the dressing will be changed to saline-treated dressing on post-operative day 2 which will remain on the incision through post-operative day 7.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="329"/>
                <participants group_id="P2" count="328"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="271"/>
                <participants group_id="P2" count="260"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="58"/>
                <participants group_id="P2" count="68"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>ineligible skin incision</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>ineligible uterine incision</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="53"/>
                <participants group_id="P2" count="65"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Telfa Pad Dressing</title>
          <description>Telfa pad dressing placed over Cesarean wound after skin closure; the dressing will be changed to a new Telfa pad dressing on post-operative day 2 which will remain on the incision through post-operative day 7.&#xD;
Telfa pad dressing: Telfa pad dressing placed over Cesarean wound after skin closure; the dressing will be changed to a new Telfa pad dressing on post-operative day 2 which will remain on the incision through post-operative day 7.</description>
        </group>
        <group group_id="B2">
          <title>Silver-impregnated Dressing</title>
          <description>Silver-impregnated dressing placed over Cesarean wound after skin closure; the dressing will be changed to saline-treated dressing on post-operative day 2 which will remain on the incision through post-operative day 7.&#xD;
Silver-impregnated dressing: Silver-impregnated dressing placed over Cesarean wound after skin closure; the dressing will be changed to saline-treated dressing on post-operative day 2 which will remain on the incision through post-operative day 7.</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="329"/>
            <count group_id="B2" value="328"/>
            <count group_id="B3" value="657"/>
          </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="329"/>
                    <measurement group_id="B2" value="328"/>
                    <measurement group_id="B3" value="657"/>
                  </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>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="31.0" spread="5.5"/>
                    <measurement group_id="B2" value="30.9" spread="5.6"/>
                    <measurement group_id="B3" value="31.0" spread="5.6"/>
                  </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="329"/>
                    <measurement group_id="B2" value="328"/>
                    <measurement group_id="B3" value="657"/>
                  </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="329"/>
                    <measurement group_id="B2" value="328"/>
                    <measurement group_id="B3" value="657"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Patients Who Develop a Surgical Site Infection</title>
        <description>A surgical site infection involving the skin and subcutaneous tissue is defined as either&#xD;
The presence of a purulent discharge from the wound on inspection, or&#xD;
Purulent discharge obtained from the wound after exploration based on the suspicion of the provider (erythema, swelling, heat or pain), or&#xD;
The presence of a seroma or hematoma discharge from the wound on inspection or after exploration that also involves isolation of an organism from an aseptically obtained culture based on suspicion of the provider (erythema, swelling, heat or pain). Seromas or hematomas with negative cultures will not be considered a surgical site infection.</description>
        <time_frame>from post operative day #1 through post operative day 30</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Telfa Pad Dressing</title>
            <description>Telfa pad dressing placed over Cesarean wound after skin closure; the dressing will be changed to a new Telfa pad dressing on post-operative day 2 which will remain on the incision through post-operative day 7.&#xD;
Telfa pad dressing: Telfa pad dressing placed over Cesarean wound after skin closure; the dressing will be changed to a new Telfa pad dressing on post-operative day 2 which will remain on the incision through post-operative day 7.</description>
          </group>
          <group group_id="O2">
            <title>Silver-impregnated Dressing</title>
            <description>Silver-impregnated dressing placed over Cesarean wound after skin closure; the dressing will be changed to saline-treated dressing on post-operative day 2 which will remain on the incision through post-operative day 7.&#xD;
Silver-impregnated dressing: Silver-impregnated dressing placed over Cesarean wound after skin closure; the dressing will be changed to saline-treated dressing on post-operative day 2 which will remain on the incision through post-operative day 7.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Patients Who Develop a Surgical Site Infection</title>
          <description>A surgical site infection involving the skin and subcutaneous tissue is defined as either&#xD;
The presence of a purulent discharge from the wound on inspection, or&#xD;
Purulent discharge obtained from the wound after exploration based on the suspicion of the provider (erythema, swelling, heat or pain), or&#xD;
The presence of a seroma or hematoma discharge from the wound on inspection or after exploration that also involves isolation of an organism from an aseptically obtained culture based on suspicion of the provider (erythema, swelling, heat or pain). Seromas or hematomas with negative cultures will not be considered a surgical site infection.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="329"/>
                <count group_id="O2" value="328"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14"/>
                    <measurement group_id="O2" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>With an SSI rate of 15% at Tampa General Hospital at the time of study design, a sample size of 600 patients was determined to provide a power of 80% to detect a 50% absolute reduction (15 vs. 7.5%) surgical site infection at a two sided alpha = 0.05. Assuming an approximate 10% dropout loss to follow up rate, the total sample size was adjusted to 660.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>With an SSI rate of 15% at Tampa General Hospital at the time of study design, a sample size of 600 patients was determined to provide a power of 80% to detect a 50% absolute reduction (15 vs. 7.5%) surgical site infection at a two sided alpha = 0.05. Assuming an approximate 10% dropout loss to follow up rate, the total sample size was adjusted to 660.</non_inferiority_desc>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.96</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.44</ci_lower_limit>
            <ci_upper_limit>1.96</ci_upper_limit>
            <other_analysis_desc>Besides the Chi Square, Fisher's Exact test, Student T-test, Mann Whitney U test, and logistic regression were utilized where appropriate</other_analysis_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>With an SSI rate of 15% at Tampa General Hospital at the time of study design, a sample size of 600 patients was determined to provide a power of 80% to detect a 50% absolute reduction (15% vs. 7.5%) surgical site infection at a two side alpha = 0.05. Assuming an approximate 10% dropout loss to follow up rate, the total sample size was adjusted to 660.</non_inferiority_desc>
            <p_value>&lt;0.05</p_value>
            <p_value_desc>Variables with at least a borderline association (P≤.10) were then included in a multiple logistic regression model to verify which is independently associated with the outcome of interest</p_value_desc>
            <method>Mixed Models Analysis</method>
            <method_desc>In addition to the Chi-Square, Fisher's exact test, Student T-Test, Mann Whitney U test and logistic regression were utilized when appropriate.</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Cosmetic Outcome of the Cesarean Section Incision</title>
        <description>The following instruments will be used to determine the cosmetic outcome:&#xD;
• The Modified Vancouver scar scale Range of scale values are from 0-12 (0 indicating a better outcome)</description>
        <time_frame>Post operative day 7</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Telfa Pad Dressing</title>
            <description>Telfa pad dressing placed over Cesarean wound after skin closure; the dressing will be changed to a new Telfa pad dressing on post-operative day 2 which will remain on the incision through post-operative day 7.&#xD;
Telfa pad dressing: Telfa pad dressing placed over Cesarean wound after skin closure; the dressing will be changed to a new Telfa pad dressing on post-operative day 2 which will remain on the incision through post-operative day 7.</description>
          </group>
          <group group_id="O2">
            <title>Silver-impregnated Dressing</title>
            <description>Silver-impregnated dressing placed over Cesarean wound after skin closure; the dressing will be changed to saline-treated dressing on post-operative day 2 which will remain on the incision through post-operative day 7.&#xD;
Silver-impregnated dressing: Silver-impregnated dressing placed over Cesarean wound after skin closure; the dressing will be changed to saline-treated dressing on post-operative day 2 which will remain on the incision through post-operative day 7.</description>
          </group>
        </group_list>
        <measure>
          <title>Cosmetic Outcome of the Cesarean Section Incision</title>
          <description>The following instruments will be used to determine the cosmetic outcome:&#xD;
• The Modified Vancouver scar scale Range of scale values are from 0-12 (0 indicating a better outcome)</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="329"/>
                <count group_id="O2" value="328"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.8" spread="1.8"/>
                    <measurement group_id="O2" value="3.7" spread="1.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;.05</p_value>
            <method>see below</method>
            <method_desc>Chi square, Fisher Exact, Student t-test, Wilcoxon-Mann-Whitney test where appropriate</method_desc>
            <other_analysis_desc>In addition to Chi-Square, Fisher's Exact test, Student T-test, Wilcoxon-Mann Whitney test were utilized where appropriate</other_analysis_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Cosmetic Outcome of the Cesarean Section Incision</title>
        <description>The following instruments will be used to determine the cosmetic outcome&#xD;
• The Modified Observer Scar Assessment Scale Range of scale values is from 5 - 50 ( the lower the score the better the outcome)</description>
        <time_frame>Six weeks post-operative</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Telfa Pad Dressing</title>
            <description>Telfa pad dressing placed over Cesarean wound after skin closure; the dressing will be changed to a new Telfa pad dressing on post-operative day 2 which will remain on the incision through post-operative day 7.&#xD;
Telfa pad dressing: Telfa pad dressing placed over Cesarean wound after skin closure; the dressing will be changed to a new Telfa pad dressing on post-operative day 2 which will remain on the incision through post-operative day 7.</description>
          </group>
          <group group_id="O2">
            <title>Silver-impregnated Dressing</title>
            <description>Silver-impregnated dressing placed over Cesarean wound after skin closure; the dressing will be changed to saline-treated dressing on post-operative day 2 which will remain on the incision through post-operative day 7.&#xD;
Silver-impregnated dressing: Silver-impregnated dressing placed over Cesarean wound after skin closure; the dressing will be changed to saline-treated dressing on post-operative day 2 which will remain on the incision through post-operative day 7.</description>
          </group>
        </group_list>
        <measure>
          <title>Cosmetic Outcome of the Cesarean Section Incision</title>
          <description>The following instruments will be used to determine the cosmetic outcome&#xD;
• The Modified Observer Scar Assessment Scale Range of scale values is from 5 - 50 ( the lower the score the better the outcome)</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="329"/>
                <count group_id="O2" value="328"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.4" spread="6.5"/>
                    <measurement group_id="O2" value="11.6" spread="6.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;.05</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Chi Square, Fisher's Exact, Student's T test, Wilcoxon-Mann-Whitney test and logistic regression when appropriate,</method_desc>
            <other_analysis_desc>Besides the Chi Square, Fisher's Exact test, Student T-test, Wilcoxon-Mann-Whitney Test, and logistic regression were utilized where appropriate</other_analysis_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;.05</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Chi Square, Fisher Exact, Student t-test, Wilcoxon-Mann-Whitney test</method_desc>
            <other_analysis_desc>Besides the Chi Square, Fisher's Exact test, Student T-test, Wilcoxon-Mann-Whitney test and logistic regression were utilized where appropriate</other_analysis_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Reduction of Pain After Cesarean Delivery</title>
        <description>The amount of narcotics measured in Morphine equivalent milligrams and non opioids administered during the cesarean delivery hospitalization were recorded</description>
        <time_frame>Immediately post operatively to hospital discharge</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Telfa Pad Dressing</title>
            <description>Telfa pad dressing placed over Cesarean wound after skin closure; the dressing will be changed to a new Telfa pad dressing on post-operative day 2 which will remain on the incision through post-operative day 7.&#xD;
Telfa pad dressing: Telfa pad dressing placed over Cesarean wound after skin closure; the dressing will be changed to a new Telfa pad dressing on post-operative day 2 which will remain on the incision through post-operative day 7.</description>
          </group>
          <group group_id="O2">
            <title>Silver-impregnated Dressing</title>
            <description>Silver-impregnated dressing placed over Cesarean wound after skin closure; the dressing will be changed to saline-treated dressing on post-operative day 2 which will remain on the incision through post-operative day 7.&#xD;
Silver-impregnated dressing: Silver-impregnated dressing placed over Cesarean wound after skin closure; the dressing will be changed to saline-treated dressing on post-operative day 2 which will remain on the incision through post-operative day 7.</description>
          </group>
        </group_list>
        <measure>
          <title>Reduction of Pain After Cesarean Delivery</title>
          <description>The amount of narcotics measured in Morphine equivalent milligrams and non opioids administered during the cesarean delivery hospitalization were recorded</description>
          <units>Morphine milligram equivalent</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="329"/>
                <count group_id="O2" value="328"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="90.0" lower_limit="60" upper_limit="135"/>
                    <measurement group_id="O2" value="82.5" lower_limit="52.5" upper_limit="120"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>The Number of Participants Noting Pain at the One Week Post Cesarean Visit</title>
        <description>Pain response to notable pain at wound site during 7 day post operative visit Subjective self reporting pain as yes or no.</description>
        <time_frame>Post operative day 7</time_frame>
        <population>This was the number of participants that completed the form at their 7 day post- operative visit.</population>
        <group_list>
          <group group_id="O1">
            <title>Telfa Pad Dressing</title>
            <description>Telfa pad dressing placed over Cesarean wound after skin closure; the dressing will be changed to a new Telfa pad dressing on post-operative day 2 which will remain on the incision through post-operative day 7.&#xD;
Telfa pad dressing: Telfa pad dressing placed over Cesarean wound after skin closure; the dressing will be changed to a new Telfa pad dressing on post-operative day 2 which will remain on the incision through post-operative day 7.</description>
          </group>
          <group group_id="O2">
            <title>Silver-impregnated Dressing</title>
            <description>Silver-impregnated dressing placed over Cesarean wound after skin closure; the dressing will be changed to saline-treated dressing on post-operative day 2 which will remain on the incision through post-operative day 7.&#xD;
Silver-impregnated dressing: Silver-impregnated dressing placed over Cesarean wound after skin closure; the dressing will be changed to saline-treated dressing on post-operative day 2 which will remain on the incision through post-operative day 7.</description>
          </group>
        </group_list>
        <measure>
          <title>The Number of Participants Noting Pain at the One Week Post Cesarean Visit</title>
          <description>Pain response to notable pain at wound site during 7 day post operative visit Subjective self reporting pain as yes or no.</description>
          <population>This was the number of participants that completed the form at their 7 day post- operative visit.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="299"/>
                <count group_id="O2" value="296"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23"/>
                    <measurement group_id="O2" value="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.05</p_value>
            <method>Mixed Models Analysis</method>
            <other_analysis_desc>Besides the Chi Square, Fisher's Exact test, Student T-test, Wilcoxon-Mann-Whitney test, and logistic regression were utilized where appropriate</other_analysis_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>The Number of Participants Noting Pain at the Six Weeks Post Cesarean Visit</title>
        <description>Pain response to notable pain at wound site during 6 week post operative visit Subjective self reporting of pain as yes or no.</description>
        <time_frame>6 weeks post operative</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Telfa Pad Dressing</title>
            <description>Telfa pad dressing placed over Cesarean wound after skin closure; the dressing will be changed to a new Telfa pad dressing on post-operative day 2 which will remain on the incision through post-operative day 7.&#xD;
Telfa pad dressing: Telfa pad dressing placed over Cesarean wound after skin closure; the dressing will be changed to a new Telfa pad dressing on post-operative day 2 which will remain on the incision through post-operative day 7.</description>
          </group>
          <group group_id="O2">
            <title>Silver-impregnated Dressing</title>
            <description>Silver-impregnated dressing placed over Cesarean wound after skin closure; the dressing will be changed to saline-treated dressing on post-operative day 2 which will remain on the incision through post-operative day 7.&#xD;
Silver-impregnated dressing: Silver-impregnated dressing placed over Cesarean wound after skin closure; the dressing will be changed to saline-treated dressing on post-operative day 2 which will remain on the incision through post-operative day 7.</description>
          </group>
        </group_list>
        <measure>
          <title>The Number of Participants Noting Pain at the Six Weeks Post Cesarean Visit</title>
          <description>Pain response to notable pain at wound site during 6 week post operative visit Subjective self reporting of pain as yes or no.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="263"/>
                <count group_id="O2" value="242"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.05</p_value>
            <method>Mixed Models Analysis</method>
            <other_analysis_desc>In addition to the Chi-square, Fisher's exact test, Student T-Test, Wilcoxon-Mann-Whitney test and logistic regression were utilized where approprate</other_analysis_desc>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Telfa Pad Dressing</title>
          <description>Telfa pad dressing placed over Cesarean wound after skin closure; the dressing will be changed to a new Telfa pad dressing on post-operative day 2 which will remain on the incision through post-operative day 7.&#xD;
Telfa pad dressing: Telfa pad dressing placed over Cesarean wound after skin closure; the dressing will be changed to a new Telfa pad dressing on post-operative day 2 which will remain on the incision through post-operative day 7.</description>
        </group>
        <group group_id="E2">
          <title>Silver-impregnated Dressing</title>
          <description>Silver-impregnated dressing placed over Cesarean wound after skin closure; the dressing will be changed to saline-treated dressing on post-operative day 2 which will remain on the incision through post-operative day 7.&#xD;
Silver-impregnated dressing: Silver-impregnated dressing placed over Cesarean wound after skin closure; the dressing will be changed to saline-treated dressing on post-operative day 2 which will remain on the incision through post-operative day 7.</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Systematic Assessment</default_assessment>
        <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="329"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="328"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="329"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="328"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Readmission to hospital</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="329"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="328"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="329"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="328"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Skin reaction to adhesive</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="329"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="328"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>The application was initiated in 12/12. A sponsor subsequently was identified with the addition of objectives to the study. After completion of the University Clinical Trials agreement by both parties and IRB notification, the clinical trials registration was completed with receipt in 8/13. Patients were then consented and the first randomized patient occurred 9/13.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr Sheila Connery, Associate Professor Obstetrics and Gynecology</name_or_title>
      <organization>University of South Florida</organization>
      <phone>813-259-8542</phone>
      <email>sconnery@health.usf.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/NCT01697748
org study id: USF IRB 00008650
nct id: NCT01697748
nct alias: NCT01927211
lead sponsor: 
has dmc: No
This study will investigate whether the placement of silver impregnated dressings beginning
      in the OR will improve wound healing in patients undergoing cesarean delivery compared to
      traditional Telfa pads. This study will also explore the presumed improvement in scar
      integrity when silver impregnated dressings are used compared to the Telfa pads.

      The study will compare the percentage of patients who develop a surgical site infection after
      application of silver impregnated dressings versus standard Telfa dressings. Investigators
      will also assess the cosmetic appearance and pain of the cesarean section scar at the
      patient's one week and 6 week post-operative visits.
This is a randomized, prospective study involving 660 patients undergoing cesarean sections
      at Tampa General Hospital. The control group (n=330) will receive standard Telfa pad dressing
      and the treatment group (n=330) will receive the silver impregnated dressing.

      The primary objective is to compare the percentage of patients who develop a surgical site
      infection between the two groups at the 1-week and 6-weeks post operative visits. The
      secondary objective is to assess the cosmetic outcome of the cesarean incision observed at
      the 1-week and 6-week post-operative visits. A plastic surgery investigator will also conduct
      a blinded assessment of cosmetic outcome by review of photographs taken of the wounds at
      1-week and 6-weeks.The tertiary objective is to evaluate the amount of narcotic and non
      narcotic medicine consumed during the hospitalization and query the patient with regards to
      pain involving the cesarean wound at 1 and 6 week post-operative visits
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Outcomes Assessor)
measure: Percentage of Patients Who Develop a Surgical Site Infection
time frame: from post operative day #1 through post operative day 30
description: A surgical site infection involving the skin and subcutaneous tissue is defined as either
The presence of a purulent discharge from the wound on inspection, or
Purulent discharge obtained from the wound after exploration based on the suspicion of the provider (erythema, swelling, heat or pain), or
The presence of a seroma or hematoma discharge from the wound on inspection or after exploration that also involves isolation of an organism from an aseptically obtained culture based on suspicion of the provider (erythema, swelling, heat or pain). Seromas or hematomas with negative cultures will not be considered a surgical site infection.
measure: Cosmetic Outcome of the Cesarean Section Incision
time frame: Post operative day 7
description: The following instruments will be used to determine the cosmetic outcome:
• The Modified Vancouver scar scale Range of scale values are from 0-12 (0 indicating a better outcome)
measure: Cosmetic Outcome of the Cesarean Section Incision
time frame: Six weeks post-operative
description: The following instruments will be used to determine the cosmetic outcome
• The Modified Observer Scar Assessment Scale Range of scale values is from 5 - 50 ( the lower the score the better the outcome)
measure: Reduction of Pain After Cesarean Delivery
time frame: Immediately post operatively to hospital discharge
description: The amount of narcotics measured in Morphine equivalent milligrams and non opioids administered during the cesarean delivery hospitalization were recorded
measure: The Number of Participants Noting Pain at the One Week Post Cesarean Visit
time frame: Post operative day 7
description: Pain response to notable pain at wound site during 7 day post operative visit Subjective self reporting pain as yes or no.
measure: The Number of Participants Noting Pain at the Six Weeks Post Cesarean Visit
time frame: 6 weeks post operative
description: Pain response to notable pain at wound site during 6 week post operative visit Subjective self reporting of pain as yes or no.
arm group label: Telfa pad dressing
arm group type: Placebo Comparator
description: Telfa pad dressing placed over Cesarean wound after skin closure; the dressing will be changed to a new Telfa pad dressing on post-operative day 2 which will remain on the incision through post-operative day 7.
arm group label: Silver-impregnated dressing
arm group type: Active Comparator
description: Silver-impregnated dressing placed over Cesarean wound after skin closure; the dressing will be changed to saline-treated dressing on post-operative day 2 which will remain on the incision through post-operative day 7.
intervention type: Device
intervention name: Silver-impregnated dressing
description: Silver-impregnated dressing placed over Cesarean wound after skin closure; the dressing will be changed to saline-treated dressing on post-operative day 2 which will remain on the incision through post-operative day 7.
arm group label: Silver-impregnated dressing
other name: Silverlon
intervention type: Device
intervention name: Telfa pad dressing
description: Telfa pad dressing placed over Cesarean wound after skin closure; the dressing will be changed to a new Telfa pad dressing on post-operative day 2 which will remain on the incision through post-operative day 7.
arm group label: Telfa pad dressing
other name: Telfa pad
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Sheila Connery, MD
role: Principal Investigator
affiliation: USF Health Morsani College of Medicine, Department of Obstetrics and Gynecology
facility: 
facility: 
facility: 
country: United States
citation: Opoien HK, Valbo A, Grinde-Andersen A, Walberg M. Post-cesarean surgical site infections according to CDC standards: rates and risk factors. A prospective cohort study. Acta Obstet Gynecol Scand. 2007;86(9):1097-102. doi: 10.1080/00016340701515225.
PMID: 17712651
citation: Owens SM, Brozanski BS, Meyn LA, Wiesenfeld HC. Antimicrobial prophylaxis for cesarean delivery before skin incision. Obstet Gynecol. 2009 Sep;114(3):573-579. doi: 10.1097/AOG.0b013e3181b490f1.
PMID: 19701037
citation: Olsen MA, Butler AM, Willers DM, Devkota P, Gross GA, Fraser VJ. Risk factors for surgical site infection after low transverse cesarean section. Infect Control Hosp Epidemiol. 2008 Jun;29(6):477-84; discussion 485-6. doi: 10.1086/587810.
PMID: 18510455
citation: Epstein NE. Do silver-impregnated dressings limit infections after lumbar laminectomy with instrumented fusion? Surg Neurol. 2007 Nov;68(5):483-5; discussion 485. doi: 10.1016/j.surneu.2007.05.045.
PMID: 17961738
citation: Perkins James, Pattillo Rolandid. How to Avert Postoperative Wound Complications-Treat It when It Occurs. OBG Management 2009;21(10):43-53.
citation: Huckfeldt R, Redmond C, Mikkelson D, Finley PJ, Lowe C, Robertson J. A clinical trial to investigate the effect of silver nylon dressings on mediastinitis rates in postoperative cardiac sternotomy incisions. Ostomy Wound Manage. 2008 Oct;54(10):36-41.
PMID: 18927482
citation: Leaper DJ. Silver dressings: their role in wound management. Int Wound J. 2006 Dec;3(4):282-94. doi: 10.1111/j.1742-481X.2006.00265.x.
PMID: 17199764
citation: Mustoe TA, Cooter RD, Gold MH, Hobbs FD, Ramelet AA, Shakespeare PG, Stella M, Teot L, Wood FM, Ziegler UE; International Advisory Panel on Scar Management. International clinical recommendations on scar management. Plast Reconstr Surg. 2002 Aug;110(2):560-71. doi: 10.1097/00006534-200208000-00031.
PMID: 12142678
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: Draaijers LJ, Tempelman FR, Botman YA, Tuinebreijer WE, Middelkoop E, Kreis RW, van Zuijlen PP. The patient and observer scar assessment scale: a reliable and feasible tool for scar evaluation. Plast Reconstr Surg. 2004 Jun;113(7):1960-5; discussion 1966-7. doi: 10.1097/01.prs.0000122207.28773.56.
PMID: 15253184
citation: Thomas Steve. MRSA and the Use of Silver Dressings: Overcoming Bacterial Resistance. http://www.worldwidewounds.com/2004/november/Thomas/Introducing-Silver Dressings.html.
citation: Yiannias, James. Clinical features and diagnosis of allergic contact dermatitis. http://www.uptodate.com/contents/clinical-features-and-diagnosis-of-allergic-contact-dermatitis
responsible party type: Sponsor
mesh term: Infections
mesh term: Surgical Wound Infection
mesh term: Wound Infection
mesh term: Pain, Postoperative
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 