<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/NCT03284749</url>
  </required_header>
  <id_info>
    <org_study_id>15/07</org_study_id>
    <nct_id>NCT03284749</nct_id>
  </id_info>
  <brief_title>Effect of Copper on the Healing of Obstetric Wounds</brief_title>
  <acronym>ECHO</acronym>
  <official_title>Randomised Controlled Trial on the Effect of Copper Impregnated Dressings and Maternity Pads on the Healing of Obstetric Wounds and Wound Infection</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Croydon Health Services NHS Trust</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Croydon Health Services NHS Trust</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The most common complication of vaginal delivery is perineal tearing with a prevalence of 85%&#xD;
      and 70% will need suturing. The caesarean section rate worldwide is rising and the rate in&#xD;
      Croydon University Hospital is in the region of 25% of all deliveries. One in ten women will&#xD;
      develop a wound infection of their perineal tear or caesarean section wound. Wound infection&#xD;
      can cause pain, dehiscence, delayed wound healing, prolonged hospital stay, readmissions and&#xD;
      interfere with a woman's ability to nurture their baby and enjoy motherhood. Copper has shown&#xD;
      to have strong antimicrobial properties, with the ability to kill various bacteria including&#xD;
      MRSA. It has also been shown that copper promotes new blood vessel formation and therefore&#xD;
      enhance wound healing. This study is to investigate the effect of copper impregnated&#xD;
      dressings and maternity pads on wound infection. Women will be randomised for a wound&#xD;
      dressing or maternity pad with (study group) or without copper (control group). Both the&#xD;
      clinician and the woman will be blinded to the randomised group. Wound infection will be&#xD;
      assessed via a telephone questionnaire after 7, 14 and 30 days after delivery. When wound&#xD;
      infection is suspected, based on the questionnaire, a swab of the wound site will be taken to&#xD;
      detect the causative bacteria.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a double blind randomised controlled pilot study to assess feasibility of copper&#xD;
      impregnated wound dressings and maternity pads for the healing of obstetric wounds. All women&#xD;
      having a caesarean section or with perineal sutures after a vaginal delivery will be&#xD;
      recruited from the antenatal clinic (in case of an elective caesarean section) or from the&#xD;
      maternity wards within Croydon Health Services. All women will be given a patient information&#xD;
      sheet describing the study prior to consent and will be giving adequate time to read the&#xD;
      information before signing the Informed consent. Participants will be followed up via a&#xD;
      telephone questionnaire 7, 14 and 30 days after the delivery.&#xD;
&#xD;
      Randomisation:&#xD;
&#xD;
      After inclusion all participants will be randomised for a wound dressing or maternity pad&#xD;
      with (study group) or without copper (control group). The two sets of wound dressings and&#xD;
      pads will be marked &quot;A&quot; or &quot;B&quot;. Both the clinician and the participant will be blinded to the&#xD;
      randomised group. Only the manufacturer will be aware of which group contains copper.&#xD;
&#xD;
      Copper impregnated dressings:&#xD;
&#xD;
      As soon as possible, but within 12 hours after primary closure of the caesarean section&#xD;
      incision, the randomised study dressing will be applied. The two study dressings were&#xD;
      equivalent to the dressing normally used within this Trust, except the foam of one set of&#xD;
      dressings was impregnated with 3% copper oxide ions. The two sets of wound dressings were&#xD;
      marked &quot;A&quot; and &quot;B&quot; and both the women and clinician were blinded to the randomised group.&#xD;
      According to local protocol the wound dressing will be left intact for 7 days following&#xD;
      surgery and will be renewed if necessary.&#xD;
&#xD;
      Copper impregnated maternity pads As soon as possible, but within 12 hours after suturing,&#xD;
      women will be asked to wear the study maternity pads, which will be provided. The two sets of&#xD;
      study maternity pads will be equivalent to the currently recommended pads, except that one&#xD;
      set of pads will have a thin top layer of non-woven polyester fibres with 3% copper oxide&#xD;
      ions permanently attached to it. Women will be asked to use the pads for 14 days.&#xD;
&#xD;
      Patient data, history and physical examination:&#xD;
&#xD;
      Demographic data such as age, ethnicity, height and weight will be collected as well as&#xD;
      obstetric data and delivery details. Past medical history such as concomitant (chronic)&#xD;
      diseases and the use of medications will be obtained. Wound infection will be assessed via a&#xD;
      telephone questionnaire after 7, 14 and 30 days after delivery. The data will be stored in a&#xD;
      secure room within Trust facilities. All electronic data will be stored within password&#xD;
      protected IT system within the Trust, which is only accessible by the clinical and research&#xD;
      team.&#xD;
&#xD;
      Questionnaire:&#xD;
&#xD;
      For the assessment of surgical site infection, the Post Discharge Questionnaire used by the&#xD;
      HPC surgical site infection surveillance will be used, which is according to the worldwide&#xD;
      used definition of surgical site infection by the CDC.&#xD;
&#xD;
      Statistical analysis Statistical analysis will be performed using SPSS version 20.0 or&#xD;
      higher. Infection rates in the perineal tear group and the caesarean section group will be&#xD;
      analysed seperately. The infection rates in the study group (with copper) will be compared to&#xD;
      the control group and possible risk factors for infection will be explored. the Chi-Square&#xD;
      will be used to analyse categorical variables and the T-test or Mann Whitney-U test will be&#xD;
      used to analyse continuous variables. Multivariable logistic regression will be used to&#xD;
      investigate risk factors for development of infection.&#xD;
&#xD;
      Sample size calculation Since the effect of copper on infection rates is currently unknown,&#xD;
      we will conduct a pilot study for 12 months.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 14, 2016</start_date>
  <completion_date type="Actual">December 19, 2017</completion_date>
  <primary_completion_date type="Actual">October 19, 2017</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>
    <intervention_model_description>All women are randomised to either the copper or the control group. Randomisation will be done separately for the caesarean section and vaginal delivery group.</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    <masking_description>After inclusion all patients will be randomised for a wound dressing or maternity pad with (study group) or without copper (control group). The two sets of wound dressings and pads will be marked &quot;A&quot; or &quot;B&quot;. Both the clinician and the patient will be blinded to the randomised group. Only the manufacturer will be aware of which group contains copper.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Post Discharge Questionnaire (PDQ)</measure>
    <time_frame>30 days</time_frame>
    <description>Questionnaire used by the HPC for surgical site infection surveillance. Using worldwide definition of surgical site infection by the CDC infection is present if one of the 6 criteria are met: 1) discharge pus AND antibiotics prescribed; 2) Clinical signs* AND wound dehiscence; 3) Clinical signs* AND antibiotics prescribed; 4)Uterine tenderness AND antibiotics prescribed; 5) Abdominal tenderness AND antibiotics prescribed; 6) Purulent discharge from uterus AND antibiotics prescribed.&#xD;
* Clinical signs: at least 2 of pain, heat, redness or swelling</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Length of hospitalisation</measure>
    <time_frame>30 days</time_frame>
    <description>Length of in hospital stay following child birth</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain score</measure>
    <time_frame>7, 14 and 30 days after delivery</time_frame>
    <description>Visual Analog Scale for wound pain</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">774</enrollment>
  <condition>Cesarean Section; Infection</condition>
  <condition>Perineal Infection</condition>
  <condition>Wound Infection</condition>
  <condition>Surgical Site Infection</condition>
  <arm_group>
    <arm_group_label>Copper impregnated wound dressing</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Wound dressing impregnated with 3% copper oxide ions, to be applied for 7 days after caesarean section</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Normal wound dressing</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Wound dressing without copper, to be applied for 7 days after caesarean section</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Copper impregnated maternity pads</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Maternity pads impregnated with 3% copper oxide ions, to be used for 14 days after delivery</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Normal maternity pads</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Maternity pads without copper, to be used for 14 days after delivery</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Copper impregnated wound dressing</intervention_name>
    <description>Copper impregnated wound dressing</description>
    <arm_group_label>Copper impregnated wound dressing</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Normal wound dressing</intervention_name>
    <description>Normal wound dressing</description>
    <arm_group_label>Normal wound dressing</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Copper impregnated maternity pads</intervention_name>
    <description>Copper impregnated maternity pads</description>
    <arm_group_label>Copper impregnated maternity pads</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Normal maternity pads</intervention_name>
    <description>Normal maternity pads</description>
    <arm_group_label>Normal maternity pads</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Aged 18 or over&#xD;
&#xD;
          -  Delivered by caesarean section (emergency or elective), or vaginally, sustaining a&#xD;
             perineal tear or episiotomy which needed to be sutured&#xD;
&#xD;
          -  Ability to understand and read the content of the patient information sheet (in&#xD;
             English, via an interpreter if needed and possible)&#xD;
&#xD;
          -  Ability to give informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Inability to give consent&#xD;
&#xD;
          -  Fetal or neonatal death or poor neonatal outcome&#xD;
&#xD;
          -  Obstetric anal sphincter injuries&#xD;
&#xD;
          -  Included in another study on postpartum infection&#xD;
&#xD;
          -  Wilson's disease&#xD;
&#xD;
          -  Allergy to copper&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Abdul H Sultan</last_name>
    <role>Principal Investigator</role>
    <affiliation>Croydon Health Services NHS Trust</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Croydon Health Services NHS Trust</name>
      <address>
        <city>Croydon</city>
        <zip>CR7 7YE</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <reference>
    <citation>Johnson A, Thakar R, Sultan AH. Obstetric perineal wound infection: is there underreporting? Br J Nurs. 2012 Mar 8-21;21(5):S28, S30, S32-5. doi: 10.12968/bjon.2012.21.Sup5.S28.</citation>
    <PMID>22489339</PMID>
  </reference>
  <reference>
    <citation>American College of Obstetrics and Gynecology.. Operative vaginal delivery. Clinical management guidelines for obstetrician-gynecologists. American College of Obstetrics and Gynecology. Int J Gynaecol Obstet. 2001 Jul;74(1):69-76. doi: 10.1016/s0020-7292(01)00434-9. No abstract available.</citation>
    <PMID>11480404</PMID>
  </reference>
  <reference>
    <citation>Callwood A, Thomas J. The National Sentinel Caesarean Section Audit. Pract Midwife. 2000 Jun;3(6):34-5. No abstract available.</citation>
    <PMID>11260996</PMID>
  </reference>
  <reference>
    <citation>Smaill FM, Grivell RM. Antibiotic prophylaxis versus no prophylaxis for preventing infection after cesarean section. Cochrane Database Syst Rev. 2014 Oct 28;2014(10):CD007482. doi: 10.1002/14651858.CD007482.pub3.</citation>
    <PMID>25350672</PMID>
  </reference>
  <reference>
    <citation>Declercq E, Barger M, Cabral HJ, Evans SR, Kotelchuck M, Simon C, Weiss J, Heffner LJ. Maternal outcomes associated with planned primary cesarean births compared with planned vaginal births. Obstet Gynecol. 2007 Mar;109(3):669-77. doi: 10.1097/01.AOG.0000255668.20639.40.</citation>
    <PMID>17329519</PMID>
  </reference>
  <reference>
    <citation>Hillan EM. Postoperative morbidity following Caesarean delivery. J Adv Nurs. 1995 Dec;22(6):1035-42. doi: 10.1111/j.1365-2648.1995.tb03102.x.</citation>
    <PMID>8675855</PMID>
  </reference>
  <reference>
    <citation>Henderson E, Love EJ. Incidence of hospital-acquired infections associated with caesarean section. J Hosp Infect. 1995 Apr;29(4):245-55. doi: 10.1016/0195-6701(95)90271-6.</citation>
    <PMID>7658004</PMID>
  </reference>
  <reference>
    <citation>Ward VP, Charlett A, Fagan J, Crawshaw SC. Enhanced surgical site infection surveillance following caesarean section: experience of a multicentre collaborative post-discharge system. J Hosp Infect. 2008 Oct;70(2):166-73. doi: 10.1016/j.jhin.2008.06.002. Epub 2008 Aug 23.</citation>
    <PMID>18723248</PMID>
  </reference>
  <reference>
    <citation>Creech CB, Litzner B, Talbot TR, Schaffner W. Frequency of detection of methicillin-resistant Staphylococcus aureus from rectovaginal swabs in pregnant women. Am J Infect Control. 2010 Feb;38(1):72-4. doi: 10.1016/j.ajic.2009.06.015. Epub 2009 Oct 21.</citation>
    <PMID>19836855</PMID>
  </reference>
  <reference>
    <citation>ACOG Practice Bulletin No. 120: Use of prophylactic antibiotics in labor and delivery. Obstet Gynecol. 2011 Jun;117(6):1472-1483. doi: 10.1097/AOG.0b013e3182238c31. No abstract available.</citation>
    <PMID>21606770</PMID>
  </reference>
  <reference>
    <citation>Borkow G, Gabbay J. Copper as a biocidal tool. Curr Med Chem. 2005;12(18):2163-75. doi: 10.2174/0929867054637617.</citation>
    <PMID>16101497</PMID>
  </reference>
  <reference>
    <citation>Noyce JO, Michels H, Keevil CW. Potential use of copper surfaces to reduce survival of epidemic meticillin-resistant Staphylococcus aureus in the healthcare environment. J Hosp Infect. 2006 Jul;63(3):289-97. doi: 10.1016/j.jhin.2005.12.008. Epub 2006 May 2.</citation>
    <PMID>16650507</PMID>
  </reference>
  <reference>
    <citation>O'Gorman J, Humphreys H. Application of copper to prevent and control infection. Where are we now? J Hosp Infect. 2012 Aug;81(4):217-23. doi: 10.1016/j.jhin.2012.05.009. Epub 2012 Jun 26.</citation>
    <PMID>22738611</PMID>
  </reference>
  <reference>
    <citation>Borkow G, Gabbay J, Zatcoff RC. Could chronic wounds not heal due to too low local copper levels? Med Hypotheses. 2008;70(3):610-3. doi: 10.1016/j.mehy.2007.06.006. Epub 2007 Aug 6.</citation>
    <PMID>17689198</PMID>
  </reference>
  <reference>
    <citation>Sen CK, Khanna S, Venojarvi M, Trikha P, Ellison EC, Hunt TK, Roy S. Copper-induced vascular endothelial growth factor expression and wound healing. Am J Physiol Heart Circ Physiol. 2002 May;282(5):H1821-7. doi: 10.1152/ajpheart.01015.2001.</citation>
    <PMID>11959648</PMID>
  </reference>
  <reference>
    <citation>Uauy R, Olivares M, Gonzalez M. Essentiality of copper in humans. Am J Clin Nutr. 1998 May;67(5 Suppl):952S-959S. doi: 10.1093/ajcn/67.5.952S.</citation>
    <PMID>9587135</PMID>
  </reference>
  <reference>
    <citation>Hostynek JJ, Dreher F, Maibach HI. Human skin penetration of a copper tripeptide in vitro as a function of skin layer. Inflamm Res. 2011 Jan;60(1):79-86. doi: 10.1007/s00011-010-0238-9. Epub 2010 Aug 20. Erratum In: Inflamm Res. 2011 Jun;60(6):611.</citation>
    <PMID>20721598</PMID>
  </reference>
  <verification_date>August 2018</verification_date>
  <study_first_submitted>September 13, 2017</study_first_submitted>
  <study_first_submitted_qc>September 14, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 15, 2017</study_first_posted>
  <last_update_submitted>August 2, 2018</last_update_submitted>
  <last_update_submitted_qc>August 2, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">August 3, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Croydon Health Services NHS Trust</investigator_affiliation>
    <investigator_full_name>Mr Abdul H Sultan</investigator_full_name>
    <investigator_title>Consultant Obstetrician and Gynaecologist</investigator_title>
  </responsible_party>
  <keyword>Copper Oxide</keyword>
  <keyword>Antibiotic Resistance</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</mesh_term>
    <mesh_term>Communicable Diseases</mesh_term>
    <mesh_term>Surgical Wound Infection</mesh_term>
    <mesh_term>Wound Infection</mesh_term>
    <mesh_term>Wounds and Injuries</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Copper</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>September 17, 2015</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/49/NCT03284749/Prot_SAP_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>January 12, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/49/NCT03284749/ICF_001.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT03284749
org study id: 15/07
nct id: NCT03284749
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The most common complication of vaginal delivery is perineal tearing with a prevalence of 85%
      and 70% will need suturing. The caesarean section rate worldwide is rising and the rate in
      Croydon University Hospital is in the region of 25% of all deliveries. One in ten women will
      develop a wound infection of their perineal tear or caesarean section wound. Wound infection
      can cause pain, dehiscence, delayed wound healing, prolonged hospital stay, readmissions and
      interfere with a woman's ability to nurture their baby and enjoy motherhood. Copper has shown
      to have strong antimicrobial properties, with the ability to kill various bacteria including
      MRSA. It has also been shown that copper promotes new blood vessel formation and therefore
      enhance wound healing. This study is to investigate the effect of copper impregnated
      dressings and maternity pads on wound infection. Women will be randomised for a wound
      dressing or maternity pad with (study group) or without copper (control group). Both the
      clinician and the woman will be blinded to the randomised group. Wound infection will be
      assessed via a telephone questionnaire after 7, 14 and 30 days after delivery. When wound
      infection is suspected, based on the questionnaire, a swab of the wound site will be taken to
      detect the causative bacteria.
This is a double blind randomised controlled pilot study to assess feasibility of copper
      impregnated wound dressings and maternity pads for the healing of obstetric wounds. All women
      having a caesarean section or with perineal sutures after a vaginal delivery will be
      recruited from the antenatal clinic (in case of an elective caesarean section) or from the
      maternity wards within Croydon Health Services. All women will be given a patient information
      sheet describing the study prior to consent and will be giving adequate time to read the
      information before signing the Informed consent. Participants will be followed up via a
      telephone questionnaire 7, 14 and 30 days after the delivery.

      Randomisation:

      After inclusion all participants will be randomised for a wound dressing or maternity pad
      with (study group) or without copper (control group). The two sets of wound dressings and
      pads will be marked "A" or "B". Both the clinician and the participant will be blinded to the
      randomised group. Only the manufacturer will be aware of which group contains copper.

      Copper impregnated dressings:

      As soon as possible, but within 12 hours after primary closure of the caesarean section
      incision, the randomised study dressing will be applied. The two study dressings were
      equivalent to the dressing normally used within this Trust, except the foam of one set of
      dressings was impregnated with 3% copper oxide ions. The two sets of wound dressings were
      marked "A" and "B" and both the women and clinician were blinded to the randomised group.
      According to local protocol the wound dressing will be left intact for 7 days following
      surgery and will be renewed if necessary.

      Copper impregnated maternity pads As soon as possible, but within 12 hours after suturing,
      women will be asked to wear the study maternity pads, which will be provided. The two sets of
      study maternity pads will be equivalent to the currently recommended pads, except that one
      set of pads will have a thin top layer of non-woven polyester fibres with 3% copper oxide
      ions permanently attached to it. Women will be asked to use the pads for 14 days.

      Patient data, history and physical examination:

      Demographic data such as age, ethnicity, height and weight will be collected as well as
      obstetric data and delivery details. Past medical history such as concomitant (chronic)
      diseases and the use of medications will be obtained. Wound infection will be assessed via a
      telephone questionnaire after 7, 14 and 30 days after delivery. The data will be stored in a
      secure room within Trust facilities. All electronic data will be stored within password
      protected IT system within the Trust, which is only accessible by the clinical and research
      team.

      Questionnaire:

      For the assessment of surgical site infection, the Post Discharge Questionnaire used by the
      HPC surgical site infection surveillance will be used, which is according to the worldwide
      used definition of surgical site infection by the CDC.

      Statistical analysis Statistical analysis will be performed using SPSS version 20.0 or
      higher. Infection rates in the perineal tear group and the caesarean section group will be
      analysed seperately. The infection rates in the study group (with copper) will be compared to
      the control group and possible risk factors for infection will be explored. the Chi-Square
      will be used to analyse categorical variables and the T-test or Mann Whitney-U test will be
      used to analyse continuous variables. Multivariable logistic regression will be used to
      investigate risk factors for development of infection.

      Sample size calculation Since the effect of copper on infection rates is currently unknown,
      we will conduct a pilot study for 12 months.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: All women are randomised to either the copper or the control group. Randomisation will be done separately for the caesarean section and vaginal delivery group.
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
masking description: After inclusion all patients will be randomised for a wound dressing or maternity pad with (study group) or without copper (control group). The two sets of wound dressings and pads will be marked "A" or "B". Both the clinician and the patient will be blinded to the randomised group. Only the manufacturer will be aware of which group contains copper.
measure: Post Discharge Questionnaire (PDQ)
time frame: 30 days
description: Questionnaire used by the HPC for surgical site infection surveillance. Using worldwide definition of surgical site infection by the CDC infection is present if one of the 6 criteria are met: 1) discharge pus AND antibiotics prescribed; 2) Clinical signs* AND wound dehiscence; 3) Clinical signs* AND antibiotics prescribed; 4)Uterine tenderness AND antibiotics prescribed; 5) Abdominal tenderness AND antibiotics prescribed; 6) Purulent discharge from uterus AND antibiotics prescribed.
* Clinical signs: at least 2 of pain, heat, redness or swelling
measure: Length of hospitalisation
time frame: 30 days
description: Length of in hospital stay following child birth
measure: Pain score
time frame: 7, 14 and 30 days after delivery
description: Visual Analog Scale for wound pain
arm group label: Copper impregnated wound dressing
arm group type: Experimental
description: Wound dressing impregnated with 3% copper oxide ions, to be applied for 7 days after caesarean section
arm group label: Normal wound dressing
arm group type: Placebo Comparator
description: Wound dressing without copper, to be applied for 7 days after caesarean section
arm group label: Copper impregnated maternity pads
arm group type: Experimental
description: Maternity pads impregnated with 3% copper oxide ions, to be used for 14 days after delivery
arm group label: Normal maternity pads
arm group type: Placebo Comparator
description: Maternity pads without copper, to be used for 14 days after delivery
intervention type: Other
intervention name: Copper impregnated wound dressing
description: Copper impregnated wound dressing
arm group label: Copper impregnated wound dressing
intervention type: Other
intervention name: Normal wound dressing
description: Normal wound dressing
arm group label: Normal wound dressing
intervention type: Other
intervention name: Copper impregnated maternity pads
description: Copper impregnated maternity pads
arm group label: Copper impregnated maternity pads
intervention type: Other
intervention name: Normal maternity pads
description: Normal maternity pads
arm group label: Normal maternity pads
criteria: 
gender: Female
gender based: Yes
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Abdul H Sultan
role: Principal Investigator
affiliation: Croydon Health Services NHS Trust
facility: 
country: United Kingdom
citation: Johnson A, Thakar R, Sultan AH. Obstetric perineal wound infection: is there underreporting? Br J Nurs. 2012 Mar 8-21;21(5):S28, S30, S32-5. doi: 10.12968/bjon.2012.21.Sup5.S28.
PMID: 22489339
citation: American College of Obstetrics and Gynecology.. Operative vaginal delivery. Clinical management guidelines for obstetrician-gynecologists. American College of Obstetrics and Gynecology. Int J Gynaecol Obstet. 2001 Jul;74(1):69-76. doi: 10.1016/s0020-7292(01)00434-9. No abstract available.
PMID: 11480404
citation: Callwood A, Thomas J. The National Sentinel Caesarean Section Audit. Pract Midwife. 2000 Jun;3(6):34-5. No abstract available.
PMID: 11260996
citation: Smaill FM, Grivell RM. Antibiotic prophylaxis versus no prophylaxis for preventing infection after cesarean section. Cochrane Database Syst Rev. 2014 Oct 28;2014(10):CD007482. doi: 10.1002/14651858.CD007482.pub3.
PMID: 25350672
citation: Declercq E, Barger M, Cabral HJ, Evans SR, Kotelchuck M, Simon C, Weiss J, Heffner LJ. Maternal outcomes associated with planned primary cesarean births compared with planned vaginal births. Obstet Gynecol. 2007 Mar;109(3):669-77. doi: 10.1097/01.AOG.0000255668.20639.40.
PMID: 17329519
citation: Hillan EM. Postoperative morbidity following Caesarean delivery. J Adv Nurs. 1995 Dec;22(6):1035-42. doi: 10.1111/j.1365-2648.1995.tb03102.x.
PMID: 8675855
citation: Henderson E, Love EJ. Incidence of hospital-acquired infections associated with caesarean section. J Hosp Infect. 1995 Apr;29(4):245-55. doi: 10.1016/0195-6701(95)90271-6.
PMID: 7658004
citation: Ward VP, Charlett A, Fagan J, Crawshaw SC. Enhanced surgical site infection surveillance following caesarean section: experience of a multicentre collaborative post-discharge system. J Hosp Infect. 2008 Oct;70(2):166-73. doi: 10.1016/j.jhin.2008.06.002. Epub 2008 Aug 23.
PMID: 18723248
citation: Creech CB, Litzner B, Talbot TR, Schaffner W. Frequency of detection of methicillin-resistant Staphylococcus aureus from rectovaginal swabs in pregnant women. Am J Infect Control. 2010 Feb;38(1):72-4. doi: 10.1016/j.ajic.2009.06.015. Epub 2009 Oct 21.
PMID: 19836855
citation: ACOG Practice Bulletin No. 120: Use of prophylactic antibiotics in labor and delivery. Obstet Gynecol. 2011 Jun;117(6):1472-1483. doi: 10.1097/AOG.0b013e3182238c31. No abstract available.
PMID: 21606770
citation: Borkow G, Gabbay J. Copper as a biocidal tool. Curr Med Chem. 2005;12(18):2163-75. doi: 10.2174/0929867054637617.
PMID: 16101497
citation: Noyce JO, Michels H, Keevil CW. Potential use of copper surfaces to reduce survival of epidemic meticillin-resistant Staphylococcus aureus in the healthcare environment. J Hosp Infect. 2006 Jul;63(3):289-97. doi: 10.1016/j.jhin.2005.12.008. Epub 2006 May 2.
PMID: 16650507
citation: O'Gorman J, Humphreys H. Application of copper to prevent and control infection. Where are we now? J Hosp Infect. 2012 Aug;81(4):217-23. doi: 10.1016/j.jhin.2012.05.009. Epub 2012 Jun 26.
PMID: 22738611
citation: Borkow G, Gabbay J, Zatcoff RC. Could chronic wounds not heal due to too low local copper levels? Med Hypotheses. 2008;70(3):610-3. doi: 10.1016/j.mehy.2007.06.006. Epub 2007 Aug 6.
PMID: 17689198
citation: Sen CK, Khanna S, Venojarvi M, Trikha P, Ellison EC, Hunt TK, Roy S. Copper-induced vascular endothelial growth factor expression and wound healing. Am J Physiol Heart Circ Physiol. 2002 May;282(5):H1821-7. doi: 10.1152/ajpheart.01015.2001.
PMID: 11959648
citation: Uauy R, Olivares M, Gonzalez M. Essentiality of copper in humans. Am J Clin Nutr. 1998 May;67(5 Suppl):952S-959S. doi: 10.1093/ajcn/67.5.952S.
PMID: 9587135
citation: Hostynek JJ, Dreher F, Maibach HI. Human skin penetration of a copper tripeptide in vitro as a function of skin layer. Inflamm Res. 2011 Jan;60(1):79-86. doi: 10.1007/s00011-010-0238-9. Epub 2010 Aug 20. Erratum In: Inflamm Res. 2011 Jun;60(6):611.
PMID: 20721598
responsible party type: Principal Investigator
investigator affiliation: Croydon Health Services NHS Trust
investigator full name: Mr Abdul H Sultan
investigator title: Consultant Obstetrician and Gynaecologist
mesh term: Infections
mesh term: Communicable Diseases
mesh term: Surgical Wound Infection
mesh term: Wound Infection
mesh term: Wounds and Injuries
mesh term: Copper
sharing ipd: No
provided document: 
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