Topical Application of Silver Nanoparticles and Oral Pathogens in Ill Patients

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

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.

Study Overview

• Status: Completed
• Conditions: Critical Illness
• Intervention / Treatment: Other: silver nanoparticles; Other: placebo

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 Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 90 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: gel silver nanoparticles; topic gel silver nanoparticles 12 ppm	Other: silver nanoparticles; 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 Comparator: placebo; topic innocuous gel	Other: placebo; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 .	Comparison of microbial colony forming units at 6 hr of treatment with gel application

Collaborators and Investigators

• Sponsor: Universidad Autonoma de San Luis Potosí

Study record dates

Study Major Dates

• Study Start: October 1, 2014
• Primary Completion (Actual): July 1, 2015
• Study Completion (Actual): July 1, 2015

Study Registration Dates

• First Submitted: January 8, 2016
• First Submitted That Met QC Criteria: May 2, 2016
• First Posted (Estimate): May 4, 2016

Study Record Updates

• Last Update Posted (Estimate): May 4, 2016
• Last Update Submitted That Met QC Criteria: May 2, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Keywords: silver nanoparticles antimicrobial activity
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Critical Illness
• Other Study ID Numbers: UASLPFJTN

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: in process