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

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

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.

Study Overview

• Status: Completed
• Conditions: Surgical Site Infection; Orthopedic Disorders
• Intervention / Treatment: Drug: Mupirocin 2% nasal ointement; Drug: Chlorhexidine sol 4%

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 Type: Interventional
• Enrollment (Actual): 1300
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Bern, Switzerland, 3006
    • Sonnenhofspital, Lindenhofgruppe

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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	Drug: Mupirocin 2% nasal ointement; Mupirocin nasal ointement 2x/d for 5 days preoperatively; Other Names: Bactroban Nasal; Drug: Chlorhexidine sol 4%; Shower with Chlorhexidine sol 4% once a day for 5 days preoperatively; Other Names: Lifo-Scrub sol 4%
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	Drug: Chlorhexidine sol 4%; Shower with Chlorhexidine sol 4% once a day for 5 days preoperatively; Other Names: Lifo-Scrub sol 4%

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall number of participants with surgical site infections 3 months postoperatively	Phone interview and orthopedic assessement	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with surgical site infections at 1 and 3 months postoperatively	Phone interview and orthopedic assessement	1 and 3 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total screening costs	Total screening costs divided by the number of prevented SSI to assess cost-effectiveness	one year

Collaborators and Investigators

• Sponsor: Lindenhofgruppe AG
• Collaborators: Lindenhofstiftung; Labormedizinisches Zentrum Dr. Risch; Clinical Trials Unit Bern (CTU)
• Investigators: Principal Investigator: Jan Brügger, Dr. med., Lindenhofgruppe AG

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2015
• Primary Completion (Actual): October 1, 2017
• Study Completion (Actual): February 1, 2018

Study Registration Dates

• First Submitted: September 16, 2015
• First Submitted That Met QC Criteria: September 24, 2015
• First Posted (Estimate): September 25, 2015

Study Record Updates

• Last Update Posted (Actual): February 27, 2018
• Last Update Submitted That Met QC Criteria: February 26, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Keywords: Staphylococcus aureus; Surgical site infection; Orthopedic surgery; Decolonization
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Disease Attributes; Wound Infection; Infections; Communicable Diseases; Musculoskeletal Diseases; Surgical Wound Infection; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents, Local; Anti-Infective Agents; Enzyme Inhibitors; Anti-Bacterial Agents; Protein Synthesis Inhibitors; Disinfectants; Mupirocin; Chlorhexidine
• Other Study ID Numbers: 14-11-F