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This pilot randomized controlled trial evaluates the feasibility, tolerability, and preliminary efficacy of a decolonization regimen using polyhexanide in reducing Staphylococcus aureus colonization in the preoperative phase of elective spine surgery, compared to the standard mupirocin and chlorhexidine regimen. The trial involves 24 participants randomized into two groups: one receiving polyhexanide and the other receiving mupirocin and chlorhexidine. The primary outcome is the randomization rate, with secondary outcomes including other feasibility outcomes, tolerability, and efficacy measures such as the reduction in S. aureus colony-forming units (CFUs) and changes in the nasal and skin microbiome composition.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Polyhexanide | Experimental |
| |
| Mupirocin and Chlorhexidine | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Polyhexanide | Drug | Participants will apply Prontoderm® Nasal Gel and perform whole-body wash with Prontoderm® Foam daily for 5 days before surgery. |
|
| Measure | Description | Time Frame |
|---|---|---|
| randomization rate | proportion of enrolled patients who were randomized | at study completion, an average of 2 years. |
| Measure | Description | Time Frame |
|---|---|---|
| positive screening rate | proportion of screened patients who were eligible | at study completion, an average of 2 years |
| recruitment rate | proportion of eligible patients who were enrolled |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Swiss Paraplegic Centre | Nottwil | Canton of Lucerne | 6207 | Switzerland |
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| ID | Term |
|---|---|
| D013203 | Staphylococcal Infections |
| D058345 | Asymptomatic Infections |
| ID | Term |
|---|---|
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C031233 | polihexanide |
| D016712 | Mupirocin |
| D002710 | Chlorhexidine |
| ID | Term |
|---|---|
| D004852 | Epoxy Compounds |
| D004988 | Ethers, Cyclic |
| D004987 | Ethers |
| D009930 | Organic Chemicals |
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| Mupirocin and Chlorhexidine | Drug | Participants will apply Bactroban® Nasal ointment and perform whole-body wash with Lifo-Scrub® daily for 5 days before surgery. |
|
|
| at study completion, an average of 2 years |
| retention rate | treatment-specific proportion of participants remaining in the trial | at study completion, an average of 2 years |
| adherence rate | treatment-specific proportion of participants completing the treatment | at study completion, an average of 2 years |
| trial burden | NRS ranging from 0 - no burden to 10 very burdensome | from start of treatment until last visit, up to 10 days |
| tolerability of decolonization regimen | NRS ranging from 0 - well tolerable to 10 not tolerable | day 5 of treatment |
| burden caused by side effects | numeric rating scale (NRS) ranging from 0 - no burden to 10 very burdensome | day 5 of treatment |
| willingness to participate in future main trial | NRS ranging from 0 - very unlikely to 10 very likely | from start of treatment until last visit, up to 10 days |
| Staphylococcus aureus colonization | Staphylococcus aureus colony-forming units grown in cultures from nasal and skin swabs | pre-treatment (-30days to -10days before surgery), post-treatment (first day after treatment), the day of discharge (within 3 to 5 days after treatment) |
| The rate of mupirocin or oxacillin resistance | Proportion of Isolated Staphylococcus aureus Strains with Mupirocin or Oxacillin Resistance | pre-treatment (-30days to -10 days before surgery) |
| The rate of treatment side effects | signs and symptoms during treatment | day 1-5 of treatment] |
| D058070 | Asymptomatic Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011714 |
| Pyrans |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |