Preoperative Decolonization and Surgical Site Infections in Orthopaedic Surgery - 2 Year Outcome in Prosthetic Surgery

NCT03962907 | Completed Phase 4

• 1 other identifier: DECO-SSI P 2
• Study Type: interventional
• Target: 1,318
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Staphylococcus Aureus; Orthopaedic Surgery; Surgical Site Infection; Prevention

Outcome Measures

Primary Outcomes (1)

• Surgical site infections

  according CDC-Criteria

  2 years

Secondary Outcomes (4)

• Overall mortality

  2 years

• Death related to infection

  2 years

• Documented bacteria

  2 years

• Time to PJI and death

  2 years

Study Arms (4)

Carrier group - intervention

EXPERIMENTAL

BACTROBAN® Nasal ong, 3g, GSK Lifo-Scrub sol 4%®, 500ml, B. Braun

Drug: Chlorhexidine, Lifo-Scrub sol 4%®, 500ml, B. Braun; Drug: BACTROBAN® Nasal ong

Carrier group - control

NO INTERVENTION

Non - carrier group - intervention

EXPERIMENTAL

Lifo-Scrub sol 4%®, 500ml, B. Braun

Drug: Chlorhexidine, Lifo-Scrub sol 4%®, 500ml, B. Braun

Non - carrier group - control

NO INTERVENTION

Interventions

Chlorhexidine, Lifo-Scrub sol 4%®, 500ml, B. Braun DRUG

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.

Carrier group - intervention; Non - carrier group - intervention

BACTROBAN® Nasal ong DRUG

Mupirocin, BACTROBAN® Nasal ong, 3g, GSK

Carrier group - intervention

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Lindenhofgruppe AG: lead

Study Sites (1)

Sonnenhofspital, Lindenhofgruppe

Bern, 3006, Switzerland

Location

MeSH Terms

Conditions

Staphylococcal Infections; Surgical Wound Infection

Interventions

Chlorhexidine

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Wound Infection; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• Jan Brügger, MD

  Lindenhofgruppe

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants are not told colonization status or study arm. Outcome Assessor are not informed as well on this informations.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: two groups: S. aureus carrier and non-carriers. Both groups have an intervention and control arm

Study Record Dates

• First Submitted: May 22, 2019
• First Posted: May 24, 2019
• Study Start: January 1, 2019
• Primary Completion: March 30, 2020
• Study Completion: June 30, 2020
• Last Updated: July 17, 2020

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)