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Topical Application of Silver Nanoparticles and Oral Pathogens in Ill Patients

Primary Purpose

Critical Illness

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
silver nanoparticles
placebo
Sponsored by
Universidad Autonoma de San Luis Potosí
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Critical Illness focused on measuring silver nanoparticles antimicrobial activity

Eligibility Criteria

15 Years - 90 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Patients with at least 24 hrs application endotracheal tube and ventilator support were nasogastric tube ,in the ICU of Hospital Central "Dr. Ignacio Morones Prieto"
  2. Patients with at least 24 hours of ICU admission.
  3. Sedo - analgesia patients in a coma or induced coma.
  4. Over 15 years old
  5. Informed consent signed by a family member or legal guardian of the patient.

Exclusion Criteria:

  1. The patient is not taking part in another study that cause conflict with the present test.
  2. Patients who develop bronchiectasis , severe or massive hemoptysis , cystic fibrosis.
  3. Patients with known sensitivity to silver.
  4. Patients who had reported difficult intubation in the record.
  5. Patients whose physical condition does not allow the completion of the oral examination, proper sampling or application of gel.
  6. Pregnant women
  7. Patients with oral mucositis

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    gel silver nanoparticles

    placebo

    Arm Description

    topic gel silver nanoparticles 12 ppm

    topic innocuous gel

    Outcomes

    Primary Outcome Measures

    Compare Colony Forming Units after the intervention. Unique dosis.
    Before oral hygiene in the intubated patient, it was taken with sterile swab, a saliva sample which was sown in dextrose Sabouraud agar and tryptone soya agar. 6 hours later, placement of the experimental gel, retook saliva sample with a sterile swab and they seeded in the same agars . Colony forming units were counted before and after the intervention using semi-automated colony counter .

    Secondary Outcome Measures

    Full Information

    First Posted
    January 8, 2016
    Last Updated
    May 2, 2016
    Sponsor
    Universidad Autonoma de San Luis Potosí
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02761525
    Brief Title
    Topical Application of Silver Nanoparticles and Oral Pathogens in Ill Patients
    Official Title
    Topical Application of Silver Nanoparticles Reduced Oral Pathogens in Mechanically Ventilated Patients: A Randomized Controlled Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    October 2014 (undefined)
    Primary Completion Date
    July 2015 (Actual)
    Study Completion Date
    July 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Universidad Autonoma de San Luis Potosí

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of this study is to determine whether oral topic silver nanoparticles are effective to reduce potential pathogen microbial loads in mechanical ventilation patients.
    Detailed Description
    All patients were performed with oral hygiene as recommended by the clinical practice guidelines for the prevention, diagnosis and treatment of pneumonia associated with mechanical ventilation. After that, placed the treatment of an innocuous gel compound with 12ppm of silver nanoparticles or gel alone according to randomization. Then obtain and plant samples taken before the treatment 6 hours after. Comparing the results of the baseline sample with the final.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Critical Illness
    Keywords
    silver nanoparticles antimicrobial activity

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    50 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    gel silver nanoparticles
    Arm Type
    Experimental
    Arm Description
    topic gel silver nanoparticles 12 ppm
    Arm Title
    placebo
    Arm Type
    Placebo Comparator
    Arm Description
    topic innocuous gel
    Intervention Type
    Other
    Intervention Name(s)
    silver nanoparticles
    Intervention Description
    Allocation was randomized. Evaluate the effectiveness of silver nanoparticles incorporated into an innocuous gel and dished in oral mucosa surface to then compare with another innocuous gel without silver nanoparticles to reduce microbial colony forming units of pathogenic potential.
    Intervention Type
    Other
    Intervention Name(s)
    placebo
    Intervention Description
    Compare with another innocuous gel without silver nanoparticles to reduce microbial colony forming units of pathogenic potential using the same procedure to dished the gel.
    Primary Outcome Measure Information:
    Title
    Compare Colony Forming Units after the intervention. Unique dosis.
    Description
    Before oral hygiene in the intubated patient, it was taken with sterile swab, a saliva sample which was sown in dextrose Sabouraud agar and tryptone soya agar. 6 hours later, placement of the experimental gel, retook saliva sample with a sterile swab and they seeded in the same agars . Colony forming units were counted before and after the intervention using semi-automated colony counter .
    Time Frame
    Comparison of microbial colony forming units at 6 hr of treatment with gel application

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    15 Years
    Maximum Age & Unit of Time
    90 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients with at least 24 hrs application endotracheal tube and ventilator support were nasogastric tube ,in the ICU of Hospital Central "Dr. Ignacio Morones Prieto" Patients with at least 24 hours of ICU admission. Sedo - analgesia patients in a coma or induced coma. Over 15 years old Informed consent signed by a family member or legal guardian of the patient. Exclusion Criteria: The patient is not taking part in another study that cause conflict with the present test. Patients who develop bronchiectasis , severe or massive hemoptysis , cystic fibrosis. Patients with known sensitivity to silver. Patients who had reported difficult intubation in the record. Patients whose physical condition does not allow the completion of the oral examination, proper sampling or application of gel. Pregnant women Patients with oral mucositis

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    in process

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    Topical Application of Silver Nanoparticles and Oral Pathogens in Ill Patients

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