Topical Application of Silver Nanoparticles and Oral Pathogens in Ill Patients

NCT ID: NCT02761525

Last Updated: 2016-05-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-10-31
• Study Completion Date: 2015-07-31

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.

Conditions

Critical Illness

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

gel silver nanoparticles

topic gel silver nanoparticles 12 ppm

Group Type: EXPERIMENTAL

silver nanoparticles

Intervention Type: 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

topic innocuous gel

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universidad Autonoma de San Luis Potosí

OTHER

Sponsor Role: lead

Responsible Party

Francisco Javier Tejeda Nava

Dental Surgeon, Oral Pathology and Medicine, Clinical Profesor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

UASLPFJTN

Identifier Type: -

Identifier Source: org_study_id