Preoperative Decolonization and Surgical Site Infections – a Prospective Randomized Trial

Overview

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.

Full Title of Study: “Preoperative Decolonization and Surgical Site Infections – a Prospective Randomized Trial (DECO-SSI Trial)”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: October 2017

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.

Interventions

  • Drug: Mupirocin 2% nasal ointement
    • Mupirocin nasal ointement 2x/d for 5 days preoperatively
  • Drug: Chlorhexidine sol 4%
    • Shower with Chlorhexidine sol 4% once a day for 5 days preoperatively

Arms, Groups and Cohorts

  • No Intervention: Nose-SA-carriers control
    • Control Group, no intervention
  • Active Comparator: 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
  • No Intervention: Non-nose-SA-carriers control
    • Control Group, no intervention
  • Active Comparator: Non-nose-carriers decolonized
    • Chlorhexidine sol 4% shower, daily for 5 days preoperatively

Clinical Trial Outcome Measures

Primary Measures

  • Overall number of participants with surgical site infections 3 months postoperatively
    • Time Frame: 3 months
    • Phone interview and orthopedic assessement

Secondary Measures

  • Number of participants with surgical site infections at 1 and 3 months postoperatively
    • Time Frame: 1 and 3 months
    • Phone interview and orthopedic assessement

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 16 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Lindenhofgruppe AG
  • Collaborator
    • Clinical Trials Unit Bern (CTU)
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Jan Brügger, Dr. med., Principal Investigator, Lindenhofgruppe AG

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