Preoperative Decolonization and Surgical Site Infections - a Prospective Randomized Trial

Not Applicable

Completed

• Conditions: Surgical Site Infection; Orthopedic Disorders
• Interventions: Drug: Mupirocin 2% nasal ointement; Drug: Chlorhexidine sol 4%

• Registration Number: NCT02560155
• Lead Sponsor: Lindenhofgruppe AG

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2015-09-16
• Study First Submitted QC: 2015-09-24
• Study First Posted: 2015-09-25
• Study Start: 2015-11
• Primary Completion: 2017-10
• Status Verified: 2018-02
• Study Completion: 2018-02
• Last Update Submitted: 2018-02-26
• Last Update Posted: 2018-02-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1300

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nose-SA-carriers decolonized	Mupirocin 2% nasal ointement	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
Nose-SA-carriers decolonized	Chlorhexidine sol 4%	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-carriers decolonized	Chlorhexidine sol 4%	Chlorhexidine sol 4% shower, daily for 5 days preoperatively

Primary Outcome Measures

Name	Time	Method
Overall number of participants with surgical site infections 3 months postoperatively	3 months	Phone interview and orthopedic assessement

Secondary Outcome Measures

Name	Time	Method
Number of participants with surgical site infections at 1 and 3 months postoperatively	1 and 3 months	Phone interview and orthopedic assessement

Trial Locations

Locations (1)

Sonnenhofspital, Lindenhofgruppe; 🇨🇭 Bern, Switzerland