Efficacy and safety of two antibacterial treatments (Polyhexanide versus Mupirocin/Chlorhexidine) prior to a planned spinal surgery: A randomized controlled pilot trial
Descrizione riassuntiva dello studio
Staphylococcus aureus is a skin bacterium and an important pathogen. It is particularly common in surgical site infections (SSIs). Spinal surgeries have been shown to have a high SSI rate. Such infections not only lead to prolonged hospital stays and increased healthcare costs but also pose a significant threat to patient recovery and outcomes. Approximately 20-30% of the general population are nasal carriers of S. aureus, with higher rates often observed in healthcare settings and among certain patient groups. In patients with spinal cord injuries, the risk is even greater, making prevention even more critical. Combating colonization with S. aureus, especially prior to spinal surgeries, represents an urgent, only partially met need in the medical community. While nasal decolonization with Mupirocin and skin decolonization with Chlorhexidine gluconate (CHX) have been the cornerstones of strategies to prevent S. aureus infections in surgical patients, the emergence of bacterial resistance underscores the need for alternative approaches. The increasing resistance to Mupirocin, associated with failures in decolonization at high concentrations, necessitates urgent research into new decolonization agents. The research work we propose addresses this challenge and focuses on Polyhexanide, a broad-spectrum disinfectant that has proven to be a promising candidate. Its action against the bacterial cell wall represents a different mechanism than that of Mupirocin and could provide a solution to the resistance problem.
(BASEC)
Intervento studiato
In our study, participants are randomly assigned to groups. This is important to obtain reliable results from the study. This is called randomization. Each group receives a different treatment. In our study, there are two groups:
• Group 1 (experimental group): application of Polyhexanide nasal ointment twice daily and Polyhexanide whole-body wash once daily for 5 days prior to surgery.
• Group 2 (control group): application of Mupirocin nasal ointment twice daily and Chlorhexidine whole-body wash once daily for 5 days prior to surgery.
(BASEC)
Malattie studiate
Surgical site infections due to Staphylococcus aureus
(BASEC)
Age over 18 years planning an elective spinal surgery Patients colonized with Staphylococcus aureus Informed consent, documented by signature (BASEC)
Criteri di esclusione
Spinal emergency surgery Bacterial isolates with specific antibiotic resistances, such as MRSA and Mupirocin-resistant S. aureus. Participants with known allergies to any of the products used in the study Women who are pregnant (pregnancy test) or breastfeeding, Current or recent (last 14 days) antibiotic therapy known or suspected non-compliance, drug or alcohol abuse, Inability to follow the study procedures, e.g., due to language problems, mental disorders, dementia, etc. of the participant, Participation in another study with an investigational product within the last 30 days prior to and during the present study (BASEC)
Luogo dello studio
Luzern
(BASEC)
Sponsor
Swiss Paraplegic Center Nottwil, Switzerland and University of Lucerne
(BASEC)
Contatto per ulteriori informazioni sullo studio
Persona di contatto in Svizzera
Rami Sommerstein
+41 41 208 32 54
rami.sommerstein@clutterunilu.chDepartment of Healthcare Sciences and Medicine
(BASEC)
Nome del comitato etico approvante (per studi multicentrici solo il comitato principale)
Commissione d'etica svizzera nord-ovest/centrale EKNZ
(BASEC)
Data di approvazione del comitato etico
05.09.2024
(BASEC)
ID di studio ICTRP
NCT06633588 (ICTRP)
Titolo ufficiale (approvato dal comitato etico)
SPADE: Surgical Prophylaxis: Assessing Decolonization Efficacy and Safety of Polyhexanid Versus Mupirocin/CHX in Decolonizing Staphylococcus aureus Pre-operatively in Elective Spine Surgery: A Randomized Controlled Pilot Trial (BASEC)
Titolo accademico
Surgical Prophylaxis: Assessing Decolonization Efficacy of Polyhexanide Versus Mupirocin and Chlorhexidine in Decolonizing Staphylococcus Aureus Preoperatively in Elective Spine Surgery (SPADE): A Pilot Randomized Controlled Trial (ICTRP)
Titolo pubblico
Decolonization Efficacy of Polyhexanide vs. Mupirocin (ICTRP)
Malattie studiate
Staphylococcus AureusColonization, Asymptomatic (ICTRP)
Intervento studiato
Drug: PolyhexanideDrug: Mupirocin and Chlorhexidine (ICTRP)
Tipo di studio
Interventional (ICTRP)
Disegno dello studio
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Single (Outcomes Assessor). (ICTRP)
Criteri di inclusione/esclusione
Inclusion Criteria:
- Age over 18 years
- Scheduled for elective spinal surgery
- Colonized with Staphylococcus aureus
- Informed consent provided
Exclusion Criteria:
- Emergency spine surgery
- Methicillin-resistant Staphylococcus aureus (MRSA) or mupirocin-resistant S. aureus
- Known allergies to products used in the trial
- Pregnant or breastfeeding women
- Recent antibiotic therapy (within 14 days)
- Known non-compliance, substance abuse, or psychological disorders
- Participation in another antimicrobial trial within the last 30 days (ICTRP)
non disponibile
Endpoint primari e secondari
randomization rate (ICTRP)
positive screening rate;recruitment rate;retention rate;adherence rate;trial burden;tolerability of decolonization regimen;burden caused by side effects;willingness to participate in future main trial;Staphylococcus aureus colonization;The rate of mupirocin or oxacillin resistance;The rate of treatment side effects (ICTRP)
Data di registrazione
non disponibile
Inclusione del primo partecipante
non disponibile
Sponsor secondari
non disponibile
Contatti aggiuntivi
Rami Sommerstein, prof. Dr.;Swiss Paraplegic Centre, Nottwil, Switzerland, rami.sommerstein@unilu.ch, +41 412083254;+41 412083254 (ICTRP)
ID secondari
2024-08 (ICTRP)
Risultati-Dati individuali dei partecipanti
non disponibile
Ulteriori informazioni sullo studio
https://clinicaltrials.gov/ct2/show/NCT06633588 (ICTRP)
Risultati dello studio
Riepilogo dei risultati
non disponibile
Link ai risultati nel registro primario
non disponibile