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.
752 studies on the registry are indexed under Musculoskeletal Diseases; 164 are open to participants now.
This study's enrollment of 1,300 is above the median of 76 across 518 interventional studies indexed under Musculoskeletal Diseases.
Browse Musculoskeletal Diseases studies →Lindenhofgruppe AG is the lead sponsor of 6 studies on the registry; 2 are open to participants now.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Ran from Nov 2015 to primary completion in Oct 2017, 23 months.
Of 266 interventional studies with no phase under Musculoskeletal Diseases, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 36. This study's 23 months is above that.
Musculoskeletal Diseases covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.
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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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Studies of the drug tested here: Mupirocin
Lindenhofgruppe AG