Preoperative Decolonization and Surgical Site Infections - a Prospective Randomized Trial

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Preoperative Decolonization and Surgical Site Infections - a Prospective Randomized Trial (DECO-SSI Trial)

Conditions
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Orthopedic Disorders, Surgical Site Infection

Intervention / Treatment
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* Drug: Mupirocin 2% nasal ointement
* Drug: Chlorhexidine sol 4%


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patient older than 16 years patient undergoing elective orthopedic procedure at the Sonnenhof hospital decolozination protocol can be performed timely signed informed consent Exclusion Criteria: no orthopedic surgery planned allergy to mupirocin or chlorhexidine presence of a nasal foreign body no informed consent pregnancy decolozination protocol can't be followed timely patients undergoing treatment/surgery for a documented infection

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Nose-SA-carriers control<br>Control Group, no intervention | |
| Active Comparator: Nose-SA-carriers decolonized<br>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<br>* Mupirocin nasal ointement 2x/d for 5 days preoperatively<br>* Other names: Bactroban Nasal;Drug: Chlorhexidine sol 4%<br>* Shower with Chlorhexidine sol 4% once a day for 5 days preoperatively<br>* Other names: Lifo-Scrub sol 4%;|
| No Intervention: Non-nose-SA-carriers control<br>Control Group, no intervention | |
| Active Comparator: Non-nose-carriers decolonized<br>Chlorhexidine sol 4% shower, daily for 5 days preoperatively | Drug: Chlorhexidine sol 4%<br>* Shower with Chlorhexidine sol 4% once a day for 5 days preoperatively<br>* Other names: Lifo-Scrub sol 4%;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall number of participants with surgical site infections 3 months postoperatively | Phone interview and orthopedic assessement | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with surgical site infections at 1 and 3 months postoperatively | Phone interview and orthopedic assessement | 1 and 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Orthopedic surgery, Surgical site infection, Decolonization, Staphylococcus aureus