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Clinical Trials/NCT02560155
NCT02560155CompletedNot Applicable

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

Lindenhofgruppe AG1 site in 1 country1,300 target enrollmentStarted: November 2015Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
1,300
Locations
1
Primary Endpoint
Overall number of participants with surgical site infections 3 months postoperatively

Study Overview

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
16 Years to — (Child, Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

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

Intervention: Mupirocin 2% nasal ointement (Drug)

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

Intervention: Chlorhexidine sol 4% (Drug)

Non-nose-carriers decolonized

Active Comparator

Chlorhexidine sol 4% shower, daily for 5 days preoperatively

Intervention: Chlorhexidine sol 4% (Drug)

Outcomes

Primary Outcomes

Overall number of participants with surgical site infections 3 months postoperatively

Time Frame: 3 months

Phone interview and orthopedic assessement

Secondary Outcomes

  • Number of participants with surgical site infections at 1 and 3 months postoperatively(1 and 3 months)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

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