xml: <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/NCT06022835</url>
    </required_header>
    <id_info>
      <org_study_id>2019/00493</org_study_id>
      <nct_id>NCT06022835</nct_id>
    </id_info>
    <brief_title>Chlorhexidine Gluconate-gel Dressing for Exit Site Infection in Peritoneal Dialysis</brief_title>
    <official_title>Tegaderm(TM) Chlorhexidine Gluconate-gel (CHG) Dressing for the Prevention of Exit Site Infection in Patients Receiving Peritoneal Dialysis.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>National Healthcare Group, Singapore</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>National Healthcare Group, Singapore</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Exit site infection (ESI) is one of the major predisposing factors to peritoneal dialysis&#xD;
        (PD) related peritonitis. Chlorhexidine Gluconate (CHG) has been widely used for cutaneous&#xD;
        disinfection for half a century. TegadermTM CHG is a water-proof dressing with gel pads that&#xD;
        provide 2% CHG to the skin surface and effectively prevents catheter-related infections for&#xD;
        intravascular catheters. However, its use has not been accessed in patients with PD&#xD;
        catheters. We aim to evaluate the effectiveness of TegadermTM CHG dressing in preventing ESI&#xD;
        in PD patients.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Peritoneal Dialysis (PD) is one of the common therapies for patients with End Stage Renal&#xD;
        Failure (ESRF). As the global burden of chronic kidney disease continues to increase, so does&#xD;
        the need for a cost-effective renal replacement therapy (1). Patient outcomes with peritoneal&#xD;
        dialysis are comparable to or better than those with haemodialysis, and peritoneal dialysis&#xD;
        is also more cost-effective (1). It is reported that PD improves patient's well-being and has&#xD;
        greater personal freedom as compared to Hemodialysis through less restrictive life-style&#xD;
        changes (2). All dialysis treatments include a certain risk of infection because of the&#xD;
        decreased immune defenses of patients in established renal failure (ERF) and because dialysis&#xD;
        techniques increase the potential of microbial contamination (3).&#xD;
  &#xD;
        PD is associated with a high risk of infection of the peritoneum, subcutaneous tunnel and&#xD;
        catheter exit site (4). ESI is diagnosed by the presence of purulent drainage, with or&#xD;
        without erythema of the skin at the catheter-epidermal interface (5). Exit site infection&#xD;
        (ESI) increases the possibility of developing PD peritonitis which demands careful attendance&#xD;
        to these problems. It is estimated that 12% of cases of ESI results in PD peritonitis (6). As&#xD;
        many as 15%-50% of ESRF patients are on PD, but recurrent or prolonged peritonitis may causes&#xD;
        technique failure in PD (3). The majority of catheter related problems are of an infection&#xD;
        nature - mainly represented by peritonitis (61%); ESI (23%); catheter obstruction,&#xD;
        dislocation and leakage making up the rest (3). Peritonitis can be associated with severe&#xD;
        pain leading to hospitalisation, catheter loss, and a risk of death; and it therefore&#xD;
        continues to be a serious complication for PD patients (7).&#xD;
  &#xD;
        There are no recommendations what topical care of the PD catheter exit site is optimal.&#xD;
        Several methods including Povidone-Iodine, hydrogen peroxide, chlorhexidine, soap and water,&#xD;
        and topical creams such as gentamicin or mupirocin cream have been studied for exit site care&#xD;
        (8,9).&#xD;
  &#xD;
        A number of topical cleansing agents have been studied for prevention of catheter-related&#xD;
        infections however no cleansing agent has shown to be superior with respect to preventing&#xD;
        catheter-related infections (5). The International Society for Peritoneal Dialysis (ISPD)&#xD;
        recommends the use of daily topical application of antibiotic cream or ointment to the&#xD;
        catheter exit site to prevent infection and exit site be cleansed at least twice weekly and&#xD;
        every time after a shower (5).&#xD;
  &#xD;
        Appropriate care of the exit site will avoid loss of catheter and unnecessary dialysis&#xD;
        modality change. PD-related infection is the most common cause of technique failure.&#xD;
        Prevention and treatment of PD catheter related infection such as peritonitis and exit site&#xD;
        infections are important to maintain on PD therapy.&#xD;
  &#xD;
        In Khoo Teck Puat Hospital (KTPH) we had been following the ISPD guidelines on the dressing&#xD;
        recommendation to use iodine as the preferred cleansing agent and application of Gentamicin&#xD;
        cream 0.1% as prophylaxis to prevent PD exit site infection. However, we had noticed an&#xD;
        increase in patient's risk of PD ESI from 2016 0.15/year at risk, 2017 0.19/year at risk and&#xD;
        2018 0.22/year at risk. Of which 40-55% were gram positive infections, 5-15% were gram&#xD;
        negative infections and the rest were having no bacterial cultures or fungal infections. We&#xD;
        evaluated on the infection episodes and reassessed on patients technique and home environment&#xD;
        and found that reasons of infection were due to poor compliance to dressing techniques,&#xD;
        frequency of change after shower, hand washing technique and home environment cleanliness.&#xD;
  &#xD;
        Several research articles were reviewed and Chlorhexidine Gluconate (CHG) was found to be&#xD;
        used widely throughout the world for more than 50 years for cutaneous disinfection, hand&#xD;
        hygiene and oral hygiene, and the safety of CHG is well established (10).Clinically relevant&#xD;
        high-level bacterial resistance has been very rare (11).&#xD;
  &#xD;
        TegadermTM CHG Dressing had a gel pad that provides 2% CHG to the skin surface. It was proven&#xD;
        to largely reduce catheter-related bloodstream infections (CRBSI) (from 1.21 to 0.28 per 1000&#xD;
        catheter days) and vascular catheter colonization (12). The CHG dressing is recommended to be&#xD;
        worn up to 7days and provide CHG antimicrobial protection, secure adhesion, gentle removal,&#xD;
        site visibility, breathability and patient comfort (13).&#xD;
  &#xD;
        Unlike CRBSI, TegadermTM CHG Dressing was not evaluated for its effectiveness in prevention&#xD;
        of exit infection in PD patients. This would be the first study to evaluate the effectiveness&#xD;
        of TegadermTM CHG Dressing in reducing peritoneal dialysis catheter exit site infection. The&#xD;
        ease of application of the dressing will help to increase patients and caregivers' compliance&#xD;
        as the frequency of change was reduced from daily to once every 7 days. TegadermTM CHG&#xD;
        dressing also water-proof and it will helps in maintaining the exit site clean and dry. By&#xD;
        reducing the PD ESI rates, it will also helps in preventing secondary peritonitis and&#xD;
        prevents unnecessary dialysis modality changes.&#xD;
  &#xD;
        This would be the first study to evaluate the effectiveness of Tegaderm™ chlorhexidine&#xD;
        gluconate-gel (CHG) dressing for the prevention of exit site infection in patient receiving&#xD;
        peritoneal dialysis.&#xD;
  &#xD;
        Participants will use Tegaderm™ chlorhexidine gluconate-gel (CHG) dressing for a period of&#xD;
        4-6months. Results will be compared with historical data from 1st Nov 2016 to 31st Oct 2017.&#xD;
        Estimated 40 patient's historical data will be reviewed.&#xD;
  &#xD;
        New Method:&#xD;
  &#xD;
        Patients are taught to perform 7 steps handwashing, clean PD exit site with chlorhexidine&#xD;
        swab sticks, dry with gauze, and apply TegadermTM CHG Dressing. This has to be repeated every&#xD;
        7days or when the dressing is soiled.&#xD;
  &#xD;
        Old Method:&#xD;
  &#xD;
        Patients are taught to perform 7 steps handwashing, clean PD exit site with 3 swab sticks,&#xD;
        dry with gauze, apply Gentamicin cream 0.1% and cover with soft cloth dressing. This has to&#xD;
        be repeated daily after shower or when the dressing is soiled.&#xD;
  &#xD;
        References&#xD;
  &#xD;
          1. Kam TL, Chow KM, Luijtaarden M, Johnson DW, Jager KJ, Mehrotra, JR, Naicker, S,&#xD;
             Pecoits-Filho R, Yu XQ, Lameire N: Changes in the worldwide epidemiology of peritoneal&#xD;
             dialysis. Nature Reviews Nephrology, 13:90-109-3, 2017&#xD;
  &#xD;
          2. Lockwood C, Hodgkinson B, Page T: Clinical effectiveness of different approaches to&#xD;
             peritoneal dialysis catheter exit-site care. JBI Reports, 1(6): 167-201, 2003&#xD;
  &#xD;
          3. Akoh JA: Peritoneal dialysis associated infections: An update on diagnosis and&#xD;
             management. World Journal of Nephrology, 1(4):106-122, 2012&#xD;
  &#xD;
          4. Bianchi P, Buoncristiani E, Buoncristiani U: Antisepsis. Contrib Nephrol 154: 1-6, 2007&#xD;
  &#xD;
          5. Szeto CC, Kam TL, Johnson DW, Bernardini J, Dong J, Figueiredo AE, Ito Y, Kazancioglu R,&#xD;
             Moraes T, Esch SV, Brown EA: ISPD Catheter-related infection recommendations: 2017&#xD;
             Update. Perit Dial Int, 37: 141-154, 2007&#xD;
  &#xD;
          6. Brook NR, White SA, Waller JR, Nicholson ML: The surgical management of peritoneal&#xD;
             dialysis catheters. Ann R Coll Surg Engl. 86: 190-195. 2004&#xD;
  &#xD;
          7. Campos RP, Chula DC, Riella MC: Complications of the peritoneal access and their&#xD;
             management. Contrib Nephrol, 163: 183-197, 2009&#xD;
  &#xD;
          8. Ques AAM, Campo MV, Arribas CM, Marcos BB, Ramos CQ, del Barrio OR, Cortes MP, Marenco&#xD;
             MT: Effectiveness of different types of care for the peritoneal dialysis catheter exit&#xD;
             site: A systematic review. JBI Database of Systematic Reviews and Implementation&#xD;
             Reports, 11(9):133-179, 2013&#xD;
  &#xD;
          9. McCormack K, Rabindranath K, Kilonzo M, Vale L, Fraser C, Mclntyre L, Thomas S, Rothnie&#xD;
             H, Fluck N, Gould IM, Waugh N: Systematic review of the effectiveness of preventing and&#xD;
             treating Staphylococcus aureus carriage in reducing peritoneal catheter-related&#xD;
             infections. Health Technol Assess, 11(23):iii-iv, ix-x, 1-66, 2007&#xD;
  &#xD;
         10. Milstone AM. Passaretti CL. Perl TM. Chlorhexidine: expanding the armamentarium for&#xD;
             infection control and prevention. Clin Infec Dis. 46:274-81, 2008&#xD;
  &#xD;
         11. McDonnell G, Russell AD. Antiseptics and disinfectants: activity, action, and&#xD;
             resistance. Clin Microbiol Rev, 12(1): 147-79, 1999&#xD;
  &#xD;
         12. Righetti M, Palmieri N, Bracchi O, Prencipe M, Bruschetta E, Colombo F, et al.: Tegaderm&#xD;
             CHG dressing significantly improves catheter-related infection rate in hemodialysis&#xD;
             patients. The journal of vascular access, 17(5):417-22, 2016&#xD;
  &#xD;
         13. https://multimedia.3m.com/mws/media/501550O/tegaderm-chg-dressing-product-brochure.pdf&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">September 27, 2019</start_date>
    <completion_date type="Actual">July 31, 2023</completion_date>
    <primary_completion_date type="Actual">July 31, 2023</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <intervention_model_description>The recruitment period was from October 2019 to August 2022. All incident PD patients aged between 21-99 years were screened. Patients allergic to chlorhexidine and Tegaderm dressing were excluded from the study. One hundred thirty-eight patients initiated PD and were screened between October 2019 and April 2022.&#xD;
  A historical cohort of incident PD patients from November 2016 to October 2017 with the same inclusion and exclusion criteria were also recruited and compared to the CHG dressing group.</intervention_model_description>
      <primary_purpose>Prevention</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>The incidence rate of exit site infection</measure>
      <time_frame>12 weeks</time_frame>
      <description>the rate in patient months and by percentage</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>time to first ESI and PD-associated peritonitis</measure>
      <time_frame>12 weeks</time_frame>
      <description>Number of days patients have ESI/peritonitis-free survival</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>PD-associated peritonitis</measure>
      <time_frame>12 weeks</time_frame>
      <description>based on ISPD guidelines</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>PD-related hospitalisation rate</measure>
      <time_frame>12 weeks</time_frame>
      <description>hospitalisation rate in patient months</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Actual">30</enrollment>
    <condition>Peritoneal Dialysis Catheter Exit Site Infection</condition>
    <condition>End Stage Renal Disease on Dialysis</condition>
    <condition>Dialysis; Complications</condition>
    <arm_group>
      <arm_group_label>Chlorhexidine Gluconate-gel (CHG) Dressing group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants used Tegaderm™ CHG dressing for 4 months. The dressing was changed every seven days or soiled.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Chlorhexidine Gluconate-gel (CHG) Dressing</intervention_name>
      <description>Participants used Tegaderm™ CHG dressing for 4 months. The dressing was changed every seven days or soiled.</description>
      <arm_group_label>Chlorhexidine Gluconate-gel (CHG) Dressing group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          All incident PD patients&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          Patients allergic to chlorhexidine and Tegaderm dressing&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>21 Years</minimum_age>
      <maximum_age>99 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Allen Yan Lun Liu</last_name>
      <role>Study Chair</role>
      <affiliation>Khoo Teck Puat Hospital, Singapore</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Allen Liu</name>
        <address>
          <city>Singapore</city>
          <country>Singapore</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Singapore</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 28, 2023</study_first_submitted>
    <study_first_submitted_qc>August 28, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 5, 2023</study_first_posted>
    <last_update_submitted>August 28, 2023</last_update_submitted>
    <last_update_submitted_qc>August 28, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 5, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>National Healthcare Group, Singapore</investigator_affiliation>
      <investigator_full_name>Allen Liu Yan Lun</investigator_full_name>
      <investigator_title>Senior Consultant</investigator_title>
    </responsible_party>
    <keyword>peritoneal dialysis</keyword>
    <keyword>exit site infection</keyword>
    <keyword>chlorhexidine</keyword>
    <keyword>dressing</keyword>
    <keyword>End stage renal disease</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>Kidney Diseases</mesh_term>
      <mesh_term>Kidney Failure, Chronic</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Chlorhexidine</mesh_term>
      <mesh_term>Chlorhexidine gluconate</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06022835
  org study id: 2019/00493
  nct id: NCT06022835
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  Exit site infection (ESI) is one of the major predisposing factors to peritoneal dialysis
        (PD) related peritonitis. Chlorhexidine Gluconate (CHG) has been widely used for cutaneous
        disinfection for half a century. TegadermTM CHG is a water-proof dressing with gel pads that
        provide 2% CHG to the skin surface and effectively prevents catheter-related infections for
        intravascular catheters. However, its use has not been accessed in patients with PD
        catheters. We aim to evaluate the effectiveness of TegadermTM CHG dressing in preventing ESI
        in PD patients.
  Peritoneal Dialysis (PD) is one of the common therapies for patients with End Stage Renal
        Failure (ESRF). As the global burden of chronic kidney disease continues to increase, so does
        the need for a cost-effective renal replacement therapy (1). Patient outcomes with peritoneal
        dialysis are comparable to or better than those with haemodialysis, and peritoneal dialysis
        is also more cost-effective (1). It is reported that PD improves patient's well-being and has
        greater personal freedom as compared to Hemodialysis through less restrictive life-style
        changes (2). All dialysis treatments include a certain risk of infection because of the
        decreased immune defenses of patients in established renal failure (ERF) and because dialysis
        techniques increase the potential of microbial contamination (3).
  
        PD is associated with a high risk of infection of the peritoneum, subcutaneous tunnel and
        catheter exit site (4). ESI is diagnosed by the presence of purulent drainage, with or
        without erythema of the skin at the catheter-epidermal interface (5). Exit site infection
        (ESI) increases the possibility of developing PD peritonitis which demands careful attendance
        to these problems. It is estimated that 12% of cases of ESI results in PD peritonitis (6). As
        many as 15%-50% of ESRF patients are on PD, but recurrent or prolonged peritonitis may causes
        technique failure in PD (3). The majority of catheter related problems are of an infection
        nature - mainly represented by peritonitis (61%); ESI (23%); catheter obstruction,
        dislocation and leakage making up the rest (3). Peritonitis can be associated with severe
        pain leading to hospitalisation, catheter loss, and a risk of death; and it therefore
        continues to be a serious complication for PD patients (7).
  
        There are no recommendations what topical care of the PD catheter exit site is optimal.
        Several methods including Povidone-Iodine, hydrogen peroxide, chlorhexidine, soap and water,
        and topical creams such as gentamicin or mupirocin cream have been studied for exit site care
        (8,9).
  
        A number of topical cleansing agents have been studied for prevention of catheter-related
        infections however no cleansing agent has shown to be superior with respect to preventing
        catheter-related infections (5). The International Society for Peritoneal Dialysis (ISPD)
        recommends the use of daily topical application of antibiotic cream or ointment to the
        catheter exit site to prevent infection and exit site be cleansed at least twice weekly and
        every time after a shower (5).
  
        Appropriate care of the exit site will avoid loss of catheter and unnecessary dialysis
        modality change. PD-related infection is the most common cause of technique failure.
        Prevention and treatment of PD catheter related infection such as peritonitis and exit site
        infections are important to maintain on PD therapy.
  
        In Khoo Teck Puat Hospital (KTPH) we had been following the ISPD guidelines on the dressing
        recommendation to use iodine as the preferred cleansing agent and application of Gentamicin
        cream 0.1% as prophylaxis to prevent PD exit site infection. However, we had noticed an
        increase in patient's risk of PD ESI from 2016 0.15/year at risk, 2017 0.19/year at risk and
        2018 0.22/year at risk. Of which 40-55% were gram positive infections, 5-15% were gram
        negative infections and the rest were having no bacterial cultures or fungal infections. We
        evaluated on the infection episodes and reassessed on patients technique and home environment
        and found that reasons of infection were due to poor compliance to dressing techniques,
        frequency of change after shower, hand washing technique and home environment cleanliness.
  
        Several research articles were reviewed and Chlorhexidine Gluconate (CHG) was found to be
        used widely throughout the world for more than 50 years for cutaneous disinfection, hand
        hygiene and oral hygiene, and the safety of CHG is well established (10).Clinically relevant
        high-level bacterial resistance has been very rare (11).
  
        TegadermTM CHG Dressing had a gel pad that provides 2% CHG to the skin surface. It was proven
        to largely reduce catheter-related bloodstream infections (CRBSI) (from 1.21 to 0.28 per 1000
        catheter days) and vascular catheter colonization (12). The CHG dressing is recommended to be
        worn up to 7days and provide CHG antimicrobial protection, secure adhesion, gentle removal,
        site visibility, breathability and patient comfort (13).
  
        Unlike CRBSI, TegadermTM CHG Dressing was not evaluated for its effectiveness in prevention
        of exit infection in PD patients. This would be the first study to evaluate the effectiveness
        of TegadermTM CHG Dressing in reducing peritoneal dialysis catheter exit site infection. The
        ease of application of the dressing will help to increase patients and caregivers' compliance
        as the frequency of change was reduced from daily to once every 7 days. TegadermTM CHG
        dressing also water-proof and it will helps in maintaining the exit site clean and dry. By
        reducing the PD ESI rates, it will also helps in preventing secondary peritonitis and
        prevents unnecessary dialysis modality changes.
  
        This would be the first study to evaluate the effectiveness of Tegaderm™ chlorhexidine
        gluconate-gel (CHG) dressing for the prevention of exit site infection in patient receiving
        peritoneal dialysis.
  
        Participants will use Tegaderm™ chlorhexidine gluconate-gel (CHG) dressing for a period of
        4-6months. Results will be compared with historical data from 1st Nov 2016 to 31st Oct 2017.
        Estimated 40 patient's historical data will be reviewed.
  
        New Method:
  
        Patients are taught to perform 7 steps handwashing, clean PD exit site with chlorhexidine
        swab sticks, dry with gauze, and apply TegadermTM CHG Dressing. This has to be repeated every
        7days or when the dressing is soiled.
  
        Old Method:
  
        Patients are taught to perform 7 steps handwashing, clean PD exit site with 3 swab sticks,
        dry with gauze, apply Gentamicin cream 0.1% and cover with soft cloth dressing. This has to
        be repeated daily after shower or when the dressing is soiled.
  
        References
  
          1. Kam TL, Chow KM, Luijtaarden M, Johnson DW, Jager KJ, Mehrotra, JR, Naicker, S,
             Pecoits-Filho R, Yu XQ, Lameire N: Changes in the worldwide epidemiology of peritoneal
             dialysis. Nature Reviews Nephrology, 13:90-109-3, 2017
  
          2. Lockwood C, Hodgkinson B, Page T: Clinical effectiveness of different approaches to
             peritoneal dialysis catheter exit-site care. JBI Reports, 1(6): 167-201, 2003
  
          3. Akoh JA: Peritoneal dialysis associated infections: An update on diagnosis and
             management. World Journal of Nephrology, 1(4):106-122, 2012
  
          4. Bianchi P, Buoncristiani E, Buoncristiani U: Antisepsis. Contrib Nephrol 154: 1-6, 2007
  
          5. Szeto CC, Kam TL, Johnson DW, Bernardini J, Dong J, Figueiredo AE, Ito Y, Kazancioglu R,
             Moraes T, Esch SV, Brown EA: ISPD Catheter-related infection recommendations: 2017
             Update. Perit Dial Int, 37: 141-154, 2007
  
          6. Brook NR, White SA, Waller JR, Nicholson ML: The surgical management of peritoneal
             dialysis catheters. Ann R Coll Surg Engl. 86: 190-195. 2004
  
          7. Campos RP, Chula DC, Riella MC: Complications of the peritoneal access and their
             management. Contrib Nephrol, 163: 183-197, 2009
  
          8. Ques AAM, Campo MV, Arribas CM, Marcos BB, Ramos CQ, del Barrio OR, Cortes MP, Marenco
             MT: Effectiveness of different types of care for the peritoneal dialysis catheter exit
             site: A systematic review. JBI Database of Systematic Reviews and Implementation
             Reports, 11(9):133-179, 2013
  
          9. McCormack K, Rabindranath K, Kilonzo M, Vale L, Fraser C, Mclntyre L, Thomas S, Rothnie
             H, Fluck N, Gould IM, Waugh N: Systematic review of the effectiveness of preventing and
             treating Staphylococcus aureus carriage in reducing peritoneal catheter-related
             infections. Health Technol Assess, 11(23):iii-iv, ix-x, 1-66, 2007
  
         10. Milstone AM. Passaretti CL. Perl TM. Chlorhexidine: expanding the armamentarium for
             infection control and prevention. Clin Infec Dis. 46:274-81, 2008
  
         11. McDonnell G, Russell AD. Antiseptics and disinfectants: activity, action, and
             resistance. Clin Microbiol Rev, 12(1): 147-79, 1999
  
         12. Righetti M, Palmieri N, Bracchi O, Prencipe M, Bruschetta E, Colombo F, et al.: Tegaderm
             CHG dressing significantly improves catheter-related infection rate in hemodialysis
             patients. The journal of vascular access, 17(5):417-22, 2016
  
         13. https://multimedia.3m.com/mws/media/501550O/tegaderm-chg-dressing-product-brochure.pdf
  allocation: N/A
  intervention model: Single Group Assignment
  intervention model description: The recruitment period was from October 2019 to August 2022. All incident PD patients aged between 21-99 years were screened. Patients allergic to chlorhexidine and Tegaderm dressing were excluded from the study. One hundred thirty-eight patients initiated PD and were screened between October 2019 and April 2022.
  A historical cohort of incident PD patients from November 2016 to October 2017 with the same inclusion and exclusion criteria were also recruited and compared to the CHG dressing group.
  primary purpose: Prevention
  masking: None (Open Label)
  measure: The incidence rate of exit site infection
  time frame: 12 weeks
  description: the rate in patient months and by percentage
  measure: time to first ESI and PD-associated peritonitis
  time frame: 12 weeks
  description: Number of days patients have ESI/peritonitis-free survival
  measure: PD-associated peritonitis
  time frame: 12 weeks
  description: based on ISPD guidelines
  measure: PD-related hospitalisation rate
  time frame: 12 weeks
  description: hospitalisation rate in patient months
  arm group label: Chlorhexidine Gluconate-gel (CHG) Dressing group
  arm group type: Experimental
  description: Participants used Tegaderm™ CHG dressing for 4 months. The dressing was changed every seven days or soiled.
  intervention type: Other
  intervention name: Chlorhexidine Gluconate-gel (CHG) Dressing
  description: Participants used Tegaderm™ CHG dressing for 4 months. The dressing was changed every seven days or soiled.
  arm group label: Chlorhexidine Gluconate-gel (CHG) Dressing group
  criteria: 
  gender: All
  minimum age: 21 Years
  maximum age: 99 Years
  healthy volunteers: No
  last name: Allen Yan Lun Liu
  role: Study Chair
  affiliation: Khoo Teck Puat Hospital, Singapore
  facility: 
  country: Singapore
  responsible party type: Principal Investigator
  investigator affiliation: National Healthcare Group, Singapore
  investigator full name: Allen Liu Yan Lun
  investigator title: Senior Consultant
  mesh term: Infections
  mesh term: Communicable Diseases
  mesh term: Kidney Diseases
  mesh term: Kidney Failure, Chronic
  mesh term: Chlorhexidine
  mesh term: Chlorhexidine gluconate
  sharing ipd: No