Preoperative Decolonization and Surgical Site Infections - a Prospective Randomized Trial

Surgical Site Infection Clinical Trial

— DECO-SSI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02560155
• Other study ID #: 14-11-F
• Status: Completed
• Phase: N/A
• First received: September 16, 2015
• Last updated: February 26, 2018
• Start date: November 2015
• Est. completion date: February 2018

Study information

• Verified date: February 2018
• Source: Lindenhof AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1300
• Est. completion date: February 2018
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Musculoskeletal Diseases
• Orthopedic Disorders
• Surgical Site Infection
• Surgical Wound Infection

Intervention

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

Locations

Country	Name	City	State
Switzerland	Sonnenhofspital, Lindenhofgruppe	Bern

Sponsors (4)

Lead Sponsor	Collaborator
Lindenhof AG	Clinical Trials Unit Bern (CTU), Labormedizinisches Zentrum Dr. Risch, Lindenhofstiftung

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Total screening costs	Total screening costs divided by the number of prevented SSI to assess cost-effectiveness	one year
Primary	Overall number of participants with surgical site infections 3 months postoperatively	Phone interview and orthopedic assessement	3 months
Secondary	Number of participants with surgical site infections at 1 and 3 months postoperatively	Phone interview and orthopedic assessement	1 and 3 months