Efficacy and safety of two antibacterial treatments (Polyhexanide versus Mupirocin/Chlorhexidine) prior to a planned spinal surgery: A randomized controlled pilot trial
Summary description of the study
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)
Intervention under investigation
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)
Disease under investigation
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)
Exclusion criteria
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)
Trial sites
Luzern
(BASEC)
Sponsor
Swiss Paraplegic Center Nottwil, Switzerland and University of Lucerne
(BASEC)
Contact
Contact Person Switzerland
Rami Sommerstein
+41 41 208 32 54
rami.sommerstein@clutterunilu.chDepartment of Healthcare Sciences and Medicine
(BASEC)
General Information
+41 412083254+41 412083254
rami.sommerstein@clutterunilu.chrami.sommerstein@clutterunilu.ch(ICTRP)
Name of the authorising ethics committee (for multicentre studies, only the lead committee)
Ethics Committee northwest/central Switzerland EKNZ
(BASEC)
Date of authorisation
05.09.2024
(BASEC)
ICTRP Trial ID
NCT06633588 (ICTRP)
Official title (approved by ethics committee)
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)
Academic title
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)
Public title
Decolonization Efficacy of Polyhexanide vs. Mupirocin (ICTRP)
Disease under investigation
Staphylococcus AureusColonization, Asymptomatic (ICTRP)
Intervention under investigation
Drug: PolyhexanideDrug: Mupirocin and Chlorhexidine (ICTRP)
Type of trial
Interventional (ICTRP)
Trial design
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Single (Outcomes Assessor). (ICTRP)
Inclusion/Exclusion criteria
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)
not available
Primary and secondary end points
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)
Registration date
not available
Incorporation of the first participant
not available
Secondary sponsors
not available
Additional contacts
Rami Sommerstein, prof. Dr.;Swiss Paraplegic Centre, Nottwil, Switzerland, rami.sommerstein@unilu.ch, +41 412083254;+41 412083254 (ICTRP)
Secondary trial IDs
2024-08 (ICTRP)
Results-Individual Participant Data (IPD)
not available
Further information on the trial
https://clinicaltrials.gov/study/NCT06633588 (ICTRP)
Results of the trial
Results summary
not available
Link to the results in the primary register
not available