NCT02560155

Preoperative Decolonization and Surgical Site Infections - a Prospective Randomized Trial

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,300 (actual)
• Sponsor: Lindenhofgruppe AG · Industry
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Orthopedic Disorders
• Surgical Site Infection

Interventions

Type	Name	Description
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

Timeline

• Start date: 2015-11-01
• Primary completion: 2017-10-01
• Completion: 2018-02-01
• First posted: 2015-09-25
• Last updated: 2018-02-27

Locations

1 site across 1 country: Switzerland