Topical Application of Silver Nanoparticles and Oral Pathogens in Ill Patients

NCT02761525 | Completed

• 1 other identifier: UASLPFJTN
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Critical Illness

Keywords

silver nanoparticles antimicrobial activity

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

gel silver nanoparticles

EXPERIMENTAL

topic gel silver nanoparticles 12 ppm

Other: silver nanoparticles

placebo

PLACEBO COMPARATOR

topic innocuous gel

Other: placebo

Interventions

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.

gel silver nanoparticles

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.

placebo

Eligibility Criteria

• Age: 15 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidad Autonoma de San Luis Potosí: lead

MeSH Terms

Conditions

Critical Illness

Interventions

colloidal silver

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dental Surgeon, Oral Pathology and Medicine, Clinical Profesor

Study Record Dates

• First Submitted: January 8, 2016
• First Posted: May 4, 2016
• Study Start: October 1, 2014
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: May 4, 2016

Record last verified: 2016-05

Data Sharing

• IPD Sharing: Will not share