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| Name | Class |
|---|---|
| Clinical Trials Unit Bern (CTU) | UNKNOWN |
| Lindenhofstiftung | UNKNOWN |
| Labormedizinisches Zentrum Dr. Risch | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nose-SA-carriers control | No Intervention | Control Group, no intervention | |
| Nose-SA-carriers decolonized | Active Comparator | 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 |
|
| Non-nose-SA-carriers control | No Intervention | Control Group, no intervention | |
| Non-nose-carriers decolonized | Active Comparator | Chlorhexidine sol 4% shower, daily for 5 days preoperatively |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mupirocin 2% nasal ointement | Drug | Mupirocin nasal ointement 2x/d for 5 days preoperatively |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall number of participants with surgical site infections 3 months postoperatively | Phone interview and orthopedic assessement | 3 months |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Total screening costs | Total screening costs divided by the number of prevented SSI to assess cost-effectiveness | one year |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jan Brügger, Dr. med. | Lindenhofgruppe AG | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sonnenhofspital, Lindenhofgruppe | Bern | 3006 | Switzerland |
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| ID | Term |
|---|---|
| D009140 | Musculoskeletal Diseases |
| D013530 | Surgical Wound Infection |
| D013203 | Staphylococcal Infections |
| ID | Term |
|---|---|
| D014946 | Wound Infection |
| D007239 | Infections |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D016712 | Mupirocin |
| ID | Term |
|---|---|
| D004852 | Epoxy Compounds |
| D004988 | Ethers, Cyclic |
| D004987 | Ethers |
| D009930 | Organic Chemicals |
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| Chlorhexidine sol 4% | Drug | Shower with Chlorhexidine sol 4% once a day for 5 days preoperatively |
|
|
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D011714 |
| Pyrans |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005227 | Fatty Acids |
| D008055 | Lipids |