An interventional study of Mupirocin 2% nasal ointement and Chlorhexidine sol 4% in Orthopedic Disorders and Surgical Site Infection, sponsored by Lindenhofgruppe AG. Completed at 1 site in Switzerland. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2018-02-27.
Sponsored by Lindenhofgruppe AG · Not applicable, Interventional, and Prevention
Surgical site infections are a major postoperative complication and are mostly due to colonization with endogenous germs, like Staphylococcus aureus, Staphylococcus epidermidis or Propionibacterium acnes. In literature, preoperative decolonization procedures showed a trend in lowering surgical site infection rates, but especially in orthopedic surgery data is controversial and randomized controlled trials are lacking. In the main study, the study investigators aim at performing a controlled prospective randomized interventional trial to measure the impact of preoperative decolonization of nasal Staphylococcus aureus carriers on surgical site infection rates in orthopedic surgery. In an alongside study a controlled prospective randomized interventional trial to measure the impact of preoperative skin decolonization of patients undergoing an orthopedic procedure will be conducted.
All participants will be assessed for eligibility during preoperative othopedic consultation. 2-3 weeks prior operation date participants will be screened for Staph. aureus carriage by nose-swab. According to nose-swab results randomizaton and allocation to study arm will be performed.
After one and three months post-operatively participants will be asked by phone interview if surgical site infections occured. Results have to be confirmed by orthopedic surgeon if possible.
Exclusion Criteria:
Control Group, no intervention
Chlorhexidine sol 4%; Mupirocin 2% nasal ointement 1 shower/day for 5 days and Nasal ointement 2x/d in each nostril for 5 days preoperatively
Drug: Mupirocin 2% nasal ointement · Drug: Chlorhexidine sol 4%
Control Group, no intervention
Chlorhexidine sol 4% shower, daily for 5 days preoperatively
Drug: Chlorhexidine sol 4%
Mupirocin nasal ointement 2x/d for 5 days preoperatively
Also known as: Bactroban Nasal
Shower with Chlorhexidine sol 4% once a day for 5 days preoperatively
Also known as: Lifo-Scrub sol 4%
Overall number of participants with surgical site infections 3 months postoperatively
Phone interview and orthopedic assessement
Time frame: 3 months
Number of participants with surgical site infections at 1 and 3 months postoperatively
Phone interview and orthopedic assessement
Time frame: 1 and 3 months
Total screening costs
Total screening costs divided by the number of prevented SSI to assess cost-effectiveness
Time frame: one year
This study is completed, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.
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Lindenhofgruppe AG