Preoperative Decolonization and Surgical Site Infections in Orthopaedic Surgery - 2 Year Outcome in Prosthetic Surgery (DECO-SSI)

Preoperative Decolonization and Surgical Site Infections in Orthopaedic Surgery: a Prospective Randomized Controlled Trial - 2 Year Outcome in Prosthetic Surgery

Surgical site infections in orthopaedic surgery are a major problem. Decolonization has been suggested to reduce infection rates. The study was designed as a prospective, controlled, randomized, single-blinded trial to assess the influence of a decolonization procedure in S. aureus and non - S. aureus carriers. In this trial the 2 - year outcome in the subpopulation of prosthetic elective orthopaedic surgery will be evaluated.

Study Overview

• Status: Completed
• Conditions: Staphylococcus Aureus; Surgical Site Infection; Orthopaedic Surgery; Prevention
• Intervention / Treatment: Drug: Chlorhexidine, Lifo-Scrub sol 4%®, 500ml, B. Braun; Drug: BACTROBAN® Nasal ong

Detailed Description

To verify the main hypothesis, a prospective controlled randomized interventional trial with 2 parallel groups of patients of the Sonnenhof hospital undergoing an elective knee- or hip implant surgery was designed. A superiority framework for the decolonization procedure was used. All patients planned for such a procedure will be recruited during preoperative consultation by the orthopedic surgeons or by post and phone. Written informed consent will be obtained at this occasion. Study participants were screened 2-4 weeks prior intervention for nasal S. aureus colonization.

Study participants were allocated on a 1:1 basis either to an intervention or to a control group, but prosthesis implantation was not defined as randomization criteria in the initial trial. Randomization was stratified for important risk factors of SSI; procedure type (upper extremities and pelvic/hip, spine, knee and foot) and ASA-criteria (I, II, III -V). Stratification-groups were chosen in function of SSI's rate and expected number of operations/year. Randomization list were generated by the CTU and allocation was concealed using central randomization that was implemented in the REDCap data entry system.

One week prior to hospitalization patients in the intervention group received a decolonization kit by mail with instructions to apply mupirocin ointment 2% (BACTROBAN Nasal ong 3g, GSK) in each nostril 30mg (which corresponds approximately the same amount as the volume of a pea) twice a day and to shower daily (starting with the face, then from top to bottom the whole body emphasizing especially on nose, axillaries and pelvic region and then rinse. In a second time starting with the hair and then repeat the whole body. Dry with a proper towel (one for the 5 days)) with 25ml chlorhexidine gluconate soap, (Lifo-Scrub sol 4 % 500ml, B. Braun) during 5 days prior surgery. For non S. aureus carriers only skin cleansing without intranasal mupirocin application was used. This dosing schedule, mode of administration and treatment periods correspond to the allowed and recommended standards of Swissmedic and were not modified in this trial. Decolonization occured before hospitalization, as a fully completed course before surgery has been more effective. In some of the previous trials decolonization took place only at the beginning of hospitalization. The decolonization procedure was only completed after surgery had taken place and this possibly affected the results.

For practical reasons the use of a placebo kit within the control group abandoned. Operators, who are also the outcome assessors, will be blinded for either the carrier status or the decolonization procedure. Study participants will be told not to inform surgeons about performed decolonization procedure.

The incidence of PJI at two years in the intervention and control group will be assessed by phone interview.

• Study Type: Interventional
• Enrollment (Actual): 1318
• Phase: Phase 4

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• older than 16 years
• planned elective orthopedic procedure
• Decolonization protocol can be performed timely

Exclusion Criteria:

• No orthopedic prosthetic surgery planned
• Allergy to mupirocin or chlorhexidine
• Presence of a nasal foreign body
• No informed consent
• undergoing treatment/surgery for a documented infection
• already participating in the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Carrier group - intervention; BACTROBAN® Nasal ong, 3g, GSK Lifo-Scrub sol 4%®, 500ml, B. Braun	Drug: Chlorhexidine, Lifo-Scrub sol 4%®, 500ml, B. Braun; 5 - day decolonization procedure prior elective surgery. In carriers with Chlorhexidine daily showers and Mupirocin twice a day nasal ointment. In non-carriers Chlorhexidine showers will be used.; Drug: BACTROBAN® Nasal ong; Mupirocin, BACTROBAN® Nasal ong, 3g, GSK
NO_INTERVENTION: Carrier group - control
EXPERIMENTAL: Non - carrier group - intervention; Lifo-Scrub sol 4%®, 500ml, B. Braun	Drug: Chlorhexidine, Lifo-Scrub sol 4%®, 500ml, B. Braun; 5 - day decolonization procedure prior elective surgery. In carriers with Chlorhexidine daily showers and Mupirocin twice a day nasal ointment. In non-carriers Chlorhexidine showers will be used.
NO_INTERVENTION: Non - carrier group - control

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Surgical site infections	according CDC-Criteria	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall mortality		2 years
Death related to infection		2 years
Documented bacteria	of PJI	2 years
Time to PJI and death	counting from operation date	2 years

Collaborators and Investigators

• Sponsor: Lindenhofgruppe AG
• Investigators: Principal Investigator: Jan Brügger, MD, Lindenhofgruppe

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2019
• Primary Completion (ACTUAL): March 30, 2020
• Study Completion (ACTUAL): June 30, 2020

Study Registration Dates

• First Submitted: May 22, 2019
• First Submitted That Met QC Criteria: May 23, 2019
• First Posted (ACTUAL): May 24, 2019

Study Record Updates

• Last Update Posted (ACTUAL): July 17, 2020
• Last Update Submitted That Met QC Criteria: July 16, 2020
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Disease Attributes; Wound Infection; Infections; Communicable 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: DECO-SSI P 2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No