Oral hygiene in intensive care unit patients with photodynamic therapy: study protocol for randomised controlled trial

Abstract

BackgroundIn intensive care units (ICUs), nosocomial infections are prevalent conditions and they have been related to high mortality indexes. Some studies have suggested that inefficient oral hygiene and ventilator-associated pneumonia (VAP) are related. Nowadays, in the Brazilian public health system there is no well-defined protocol for oral hygiene in an ICU. Due to the drawbacks of the use of antibiotics, photodynamic therapy (PDT) has emerged as an interesting technique in order to reduce antimicrobial-resistant pathogens. Methylene blue (MB) is the most common chemical agent for PDT in Brazil. However, new formulations for improved effectiveness are still lacking. The objective of this study is to evaluate the use of an MB mouthwash as an effective oral-hygiene procedure in an ICU and to show that oral hygiene using PDT with MB mouthwash may reduce VAP frequency to rates similar to, or higher than, chlorhexidine.MethodsPhase 1 will evaluate the most effective cleaning procedure, while phase 2 will correlate oral hygiene to VAP incidence. At the start of phase 1, the ICU patients will be randomly allocated into three different groups (10 patients/group): the efficacy of chlorhexidine, classical MB-PDT, and mouthwash MB-PDT will all be measured for the quantification of viable bacteria, both pre- and post-treatment, by a Reverse Transcription Polymerase Chain Reaction (RT-PCR). In phase 2, the most effective procedure found in phase 1 and a mechanical cleaning with filtered water will be carried out daily, once a day, over 5 days, with a total of 52 ICU patients randomly allocated into the two groups. The clinical records will be evaluated in order to find any pneumonic diagnoses.DiscussionSince a variety of bacterial species are related to VAP, a universal primer for bacteria will be used in order to quantify the total bacteria count in the participants’ samples. In order to quantify only the living bacteria before DNA extraction, the samples will be treated with propidium monoazide. This will infiltrate the dead bacteria and will intercalate the DNA bases, avoiding their DNA amplification. This will be the first trial to evaluate MB-PDT in a mouthwash formula that can increase the effectiveness due to the control of MB aggregation. The results of this study will be able to generate an easy and low-cost protocol to be used in an ICU for the Brazilian public health system.Trial registrationThis protocol was approved by the Research Ethics Committee of the Conjunto Hospitalar do Mandaqui (1.317.834, CAAE: 49273515.9.3001.5551) and it was registered in Registro Brasileiro de Ensaios Clínicos (ReBEC number: RBR-94bvrc;). First received: 12 July 2015; 1st version 6 June 2016. Data will be published in a peer-reviewed journal.Electronic supplementary materialThe online version of this article (doi:10.1186/s13063-017-2133-y) contains supplementary material, which is available to authorized users.

Evaluation of photodynamic therapy in pericoronitis

“…[10,56] This fact can interfere with the antimicrobial potential of PDT, since it decreases the formation of singlet oxygen. [57] Here, by changing the MB vehicle, the study aims to verify if the reduced aggregation improves the antimicrobial effect.…”

Perfil epidemiológico e análise clínica de pacientes com pneumonia associada à ventilação mecânica em um hospital de ensino / Epidemiological profile and clinical analysis of patients with ventilation associated pneumonia in a teaching hospital

“…A ventilação mecânica invasiva causa diversas alterações no organismo, sendo o pulmão o órgão mais acometido; dentre as complicações envolvidas está a PAV. 13 PAV prolonga tempo de internação, aumenta cus-tos e aumenta a mortalidade. 14 No presente estudo, o tempo de internação do paciente que apresentou PAV foi muito elevado, com mediana de 27 dias.…”

The use of antimicrobial photodynamic therapy in oral injuries of a pediatric patient with myelodysplastic syndrome: case report

“…The topical application of a PS allows effectiveness without compromising other structures and complex systems of the organism. 8,9 Several diseases of systemic impairment may present limiting oral repercussions that interfere in the quality of life of the patients affected, as is the case of the group of the MDS. The purpose of this article is to report a case of a pediatric patient with MDS and severe oral infectious disease, in which aPDT was used as a therapeutic choice to support systemic treatment.…”

“…This technique of aPDT is minimally invasive, with no collateral effects to the host and has local and restricted action, which emphasizes its advantage in relation to the action of systemic antimicrobials and it can be considered to be economically viable. The topical application of a PS allows effectiveness without compromising other structures and complex systems of the organism …”