Topical Application of Silver Nanoparticles and Oral Pathogens in Ill Patients

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.

Completed

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Key information

Conditions

Critical Illness Disease Attributes Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

15 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

silver nanoparticles

Other

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.

Placebo

Other

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 outcomes

Compare Colony Forming Units after the intervention. Unique dosis.

Time frame: Comparison of microbial colony forming units at 6 hr of treatment with gel application

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 .

Sponsors and collaborators

Lead sponsor

Universidad Autonoma de San Luis Potosí

Other

Registry information

Official study title

Topical Application of Silver Nanoparticles Reduced Oral Pathogens in Mechanically Ventilated Patients: A Randomized Controlled Clinical Trial

Important dates

Study start: 2014
Primary completion: 2015
Study completion: 2015
First posted: May 4, 2016
Registry last updated: May 4, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed