Topical Application of Silver Nanoparticles and Oral Pathogens in Ill Patients

Critical Illness Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02761525
• Other study ID #: UASLPFJTN
• Status: Completed
• Phase: N/A
• First received: January 8, 2016
• Last updated: May 2, 2016
• Start date: October 2014
• Est. completion date: July 2015

Study information

• Verified date: May 2016
• Source: Universidad Autonoma de San Luis Potosí
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mexico: Secretaria de Salud
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years to 90 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Critical Illness

Intervention

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
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Autonoma de San Luis Potosí

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No