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Recruitment difficulties
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Staphylococcus aureus (S. aureus) is a leading cause of healthcare-associated infections worldwide. S. aureus colonizes several body sites, including the nose, throat, and perineum. Colonization by methicillin-resistant S. aureus (MRSA) increases the risk of infection by up to 27%, with infecting strains matching colonizing strains in up to 86% of cases. Decolonization, the goal of which is to decrease or eliminate bacterial load on the body, is an integral part of the strategies used to control and prevent the spread of MRSA. This approach involves eradication of MRSA carriage from the nose through the intranasal application of an antimicrobial agent and body washes with an antiseptic soap to eliminate bacteria from other body sites. The most commonly used agents for MRSA decolonization are intranasal mupirocin ointment applied to the anterior nares and chlorhexidine body wash. Postdischarge MRSA decolonization with chlorhexidine and mupirocin led to a 30% lower risk of MRSA infection. However, there are growing concerns about decolonization failures following the emergence of mupirocin and chlorhexidine resistance. Povidone iodine (PVP-I) is an alternative decolonization agent solutions and demonstrated rapid and superior bactericidal activity against MRSA in in vitro and ex vivo studies available reports. Finally, the induction of bacterial resistance or cross-resistance to antiseptics and antibiotics with PVP-I was not observed. The present protocol aims to use a "Decolonization kit" into MRSA patients to evaluate the efficacy of MRSA nasal decolonization with a topical PVP-I gel. This kit will allow a complete transient decolonization with povidone-iodine (PVP-I)-based products: nasal (gel), body (antiseptic soap) and oral (mouthwash).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Decolonization | Experimental | Nasal decolonization with betadin gel |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Betadine | Drug | Nasal decolonization with betadine gel |
|
| Measure | Description | Time Frame |
|---|---|---|
| MRSA nasal decolonization: Negative nasal screening rate 6 hours after use of the kit. | 6 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Acceptability by the patient and HCWs of the use of the complete kit by a satisfactory self- questionnaire. | 24 hours | |
| Characteristics of patients remained MRSA positive after PVP-I decolonization. | 24 hours |
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Inclusion Criteria:
Women must meet one of the following criteria at the time of inclusion:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Nantes | Nantes | 44093 | France |
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| ID | Term |
|---|---|
| D011206 | Povidone-Iodine |
| ID | Term |
|---|---|
| D007466 | Iodophors |
| D017613 | Iodine Compounds |
| D007287 | Inorganic Chemicals |
| D011145 | Polyvinyls |
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| List of adverse events reported by patients. | 24 hours |
| MRSAD decolonization: negative nasal screening rate 24 hours after use of the kit | 24 hours |
| D014753 |
| Vinyl Compounds |
| D000475 | Alkenes |
| D006839 | Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011205 | Povidone |
| D011760 | Pyrrolidinones |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D010969 | Plastics |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
| D001697 | Biomedical and Dental Materials |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |