NCT02560155

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 16, 2015

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 25, 2015

Completed
1 month until next milestone

Study Start

First participant enrolled

November 1, 2015

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2018

Completed
Last Updated

February 27, 2018

Status Verified

February 1, 2018

Enrollment Period

1.9 years

First QC Date

September 16, 2015

Last Update Submit

February 26, 2018

Conditions

Orthopedic DisordersSurgical Site Infection

Keywords

Orthopedic surgerySurgical site infectionDecolonizationStaphylococcus aureus

Outcome Measures

Primary Outcomes (1)

  • Overall number of participants with surgical site infections 3 months postoperatively

    Phone interview and orthopedic assessement

    3 months

Secondary Outcomes (1)

  • Number of participants with surgical site infections at 1 and 3 months postoperatively

    1 and 3 months

Other Outcomes (1)

  • Total screening costs

    one year

Study Arms (4)

Nose-SA-carriers control

NO INTERVENTION

Control Group, no intervention

Nose-SA-carriers decolonized

ACTIVE COMPARATOR

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 ointementDrug: Chlorhexidine sol 4%

Non-nose-SA-carriers control

NO INTERVENTION

Control Group, no intervention

Non-nose-carriers decolonized

ACTIVE COMPARATOR

Chlorhexidine sol 4% shower, daily for 5 days preoperatively

Drug: Chlorhexidine sol 4%

Interventions

Mupirocin 2% nasal ointementDRUG

Mupirocin nasal ointement 2x/d for 5 days preoperatively

Also known as: Bactroban Nasal
Nose-SA-carriers decolonized
Chlorhexidine sol 4%DRUG

Shower with Chlorhexidine sol 4% once a day for 5 days preoperatively

Also known as: Lifo-Scrub sol 4%
Non-nose-carriers decolonizedNose-SA-carriers decolonized

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • patient older than 16 years
  • patient undergoing elective orthopedic procedure at the Sonnenhof hospital
  • decolozination protocol can be performed timely
  • signed informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sonnenhofspital, Lindenhofgruppe

Bern, 3006, Switzerland

Location

MeSH Terms

Conditions

Musculoskeletal DiseasesSurgical Wound InfectionStaphylococcal Infections

Interventions

Mupirocin

Condition Hierarchy (Ancestors)

Wound InfectionInfectionsPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and Mycoses

Intervention Hierarchy (Ancestors)

Epoxy CompoundsEthers, CyclicEthersOrganic ChemicalsPyransHeterocyclic Compounds, 1-RingHeterocyclic CompoundsFatty AcidsLipids

Study Officials

  • Jan Brügger, Dr. med.

    Lindenhofgruppe AG

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 16, 2015

First Posted

September 25, 2015

Study Start

November 1, 2015

Primary Completion

October 1, 2017

Study Completion

February 1, 2018

Last Updated

February 27, 2018

Record last verified: 2018-02

Locations

CH(1)