Topical Application of Silver Nanoparticles and Oral Pathogens in Ill Patients

Not Applicable

Completed

• Conditions: Critical Illness
• Interventions: Other: placebo; Other: silver nanoparticles

• Registration Number: NCT02761525
• Lead Sponsor: Universidad Autonoma de San Luis Potosí

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.

Study Timeline

• Study Start: 2014-10
• Primary Completion: 2015-07
• Study Completion: 2015-07
• Study First Submitted: 2016-01-08
• Status Verified: 2016-05
• Study First Submitted QC: 2016-05-02
• Last Update Submitted: 2016-05-02
• Study First Posted: 2016-05-04
• Last Update Posted: 2016-05-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	placebo	topic innocuous gel
gel silver nanoparticles	silver nanoparticles	topic gel silver nanoparticles 12 ppm

Primary Outcome Measures

Name	Time	Method
Compare Colony Forming Units after the intervention. Unique dosis.	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 .