Preoperative Decolonization and Surgical Site Infections

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-30

Study Completion Date

2018-02-28

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.

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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.

Conditions

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Orthopedic Disorders Surgical Site Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Nose-SA-carriers control

Control Group, no intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

Nose-SA-carriers decolonized

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

Group Type ACTIVE_COMPARATOR

Mupirocin 2% nasal ointement

Intervention Type DRUG

Mupirocin nasal ointement 2x/d for 5 days preoperatively

Chlorhexidine sol 4%

Intervention Type DRUG

Shower with Chlorhexidine sol 4% once a day for 5 days preoperatively

Non-nose-SA-carriers control

Control Group, no intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

Non-nose-carriers decolonized

Chlorhexidine sol 4% shower, daily for 5 days preoperatively

Group Type ACTIVE_COMPARATOR

Chlorhexidine sol 4%

Intervention Type DRUG

Shower with Chlorhexidine sol 4% once a day for 5 days preoperatively

Interventions

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Mupirocin 2% nasal ointement

Mupirocin nasal ointement 2x/d for 5 days preoperatively

Intervention Type DRUG

Chlorhexidine sol 4%

Shower with Chlorhexidine sol 4% once a day for 5 days preoperatively

Intervention Type DRUG

Other Intervention Names

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Bactroban Nasal Lifo-Scrub sol 4%

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

Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No