Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.

Skin Decolonization of Children Hospitalized in Intensive Care Unit (DCpedrea)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04117776
Recruitment Status : Not yet recruiting
First Posted : October 7, 2019
Last Update Posted : October 22, 2019
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Tracking Information
First Submitted Date July 1, 2019
First Posted Date October 7, 2019
Last Update Posted Date October 22, 2019
Estimated Study Start Date December 2019
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 18, 2019)
  • Cutaneous colonization [ Time Frame: 6 months ]
    Number of colony-forming unit after 24 hours of culture of 3 samples : 1 hour before the wash (mild soap or 2% Chlorhexidine Gluconate), 1 to 2 hours after, and 20 to 23 hours after the wash.
  • Bacterial ecology [ Time Frame: 6 months ]
    Macroscopic bacterial identification after Gram staining, after 24 hours of culture of 3 samples : 1 hour before the wash (mild soap or 2% Chlorhexidine Gluconate), 1 to 2 hours after, and 20 to 23 hours after the wash. Microbiological identification if the macroscopic appearance seems atypical.
Original Primary Outcome Measures
 (submitted: October 3, 2019)
  • Cutaneous colonization [ Time Frame: 6 months ]
    Number of colony-forming unit after 24h of culture of 3 samples : 1h before the wash (mild soap or 2% Chlorhexidine Gluconate), 1 to 2 h after, and 20 to 23h after the wash.
  • Bacterial ecology [ Time Frame: 6 months ]
    Macroscopic bacterial identification after Gram staining, after 24h of culture of 3 samples : 1h before the wash (mild soap or 2% Chlorhexidine Gluconate), 1 to 2 h after, and 20 to 23h after the wash. Microbiological identification if the macroscopic appearance seems atypical.
Change History Complete list of historical versions of study NCT04117776 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Skin Decolonization of Children Hospitalized in Intensive Care Unit
Official Title Skin Decolonization of Children Hospitalized in Intensive Care Unit by Daily Toilet : Mild Soap Versus Chlorhexidine Gluconate 2% Pad
Brief Summary The purpose of this study is to evaluate the efficacy and duration of the skin decolonization brought by a daily wash using Chlorhexidine Gluconate 2% pad compared to a standard wash with mild soap in children hospitalized in intensive care unit.
Detailed Description

Skin is a major reservoir of pathogenic bacteria and intensive care unit patients are particularly vulnerable to variations in skin colonization and so to infections. These bacterial skin colonizations can contaminate other patients, nursing staff or even samples, but above all they are an endogenous source of infection of material. These bacterial skin colonizations hold therefore a major place in the responsibility of infections associated with care and can potentially affect the length of patient hospitalization. 2% Chlorhexidine Gluconate pads have already demonstrated a real efficacy in the sustainable reduction of central venous catheter-related bacteremias in adults and in children, probably through a reduction of cutaneous microbial colonization. However, this hypothesis remains to be confirmed.

Patients in the pediatric surgical intensive care unit of Necker-Enfants Malades hospital are minors, hospitalized in critical and continuous surgical surveillance unit, for all surgical specialties excluding cardiac surgery. The use of central venous catheters concerns approximately 60% of the hospitalization days identified each year. To control catheter-related bacteremias, all intensive care unit patients are subjected to a service protocol since 2015, which defines a mild soap daily wash in patients without central venous catheter and a wash with Chlorhexidine in patients with central venous catheter. Successive standardized samples will be carried out on the skin of the children submissive to both types of washes during their hospitalization in intensive care unit.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Minors hospitalized in intensive care unit of Necker Hospital.
Condition Central Venous Catheter
Intervention
  • Other: Skin microbiological sampling (wash with 2% Chlorhexidine Gluconate)
    3 microbiological samples, per application of agar on skin, after 24h of a first wash with 2% Chlorhexidine Gluconate : 1h before the second wash with the same washing product and then 1 to 2 h after, and 20 to 23h after this second wash.
    Other Name: Skin microbiological sampling
  • Other: Skin microbiological sampling (wash with mild soap)
    3 microbiological samples, per application of agar on skin, after 24h of a first wash with mild soap : 1h before the second wash with the same washing product and then 1 to 2 h after, and 20 to 23h after this second wash.
    Other Name: Skin microbiological sampling
Study Groups/Cohorts Patients
Patient benefiting during the same hospitalization of the loss or the gain of a central venous catheter.
Interventions:
  • Other: Skin microbiological sampling (wash with 2% Chlorhexidine Gluconate)
  • Other: Skin microbiological sampling (wash with mild soap)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Not yet recruiting
Estimated Enrollment
 (submitted: October 3, 2019)
30
Original Estimated Enrollment Same as current
Estimated Study Completion Date June 2020
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Patients from 0 to 17 years old
  • Hospitalized in the pediatric surgical intensive care unit of the Necker Hospital for a duration of at least 5 days
  • Patients likely to receive the 2 types of washes (mild soap and Chlorhexidine Gluconate )
  • Patients subject to the service wash protocol for at least two daily washes (24 hours)

Exclusion Criteria:

  • Patients not following the 2 types of washes
  • Chronic skin lesions
  • Refusal to participate expressed by the holders of the parental authority and/or patient
  • not respecting the 24h imposed for each wash
Sex/Gender
Sexes Eligible for Study: All
Ages up to 17 Years   (Child)
Accepts Healthy Volunteers No
Contacts
Contact: Stéphane Blanot, MD +33 1 44 49 47 68 stephane.blanot@aphp.fr
Contact: Hélène Morel +33 1 71 19 63 46 helene.morel@aphp.fr
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT04117776
Other Study ID Numbers APHP190298
2019-A00844-53 ( Other Identifier: IDRCB number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Assistance Publique - Hôpitaux de Paris
Study Sponsor Assistance Publique - Hôpitaux de Paris
Collaborators Not Provided
Investigators
Principal Investigator: Stéphane Blanot, MD Assistance Publique - Hôpitaux de Paris
Study Director: Edouard Jullien Assistance Publique - Hôpitaux de Paris
PRS Account Assistance Publique - Hôpitaux de Paris
Verification Date October 2019