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

Sponsor

Lindenhofgruppe AG (Industry)

Overall Status

Completed

CT.gov ID

NCT03962907

Collaborator

(none)

1,318

Enrollment

Location

Arms

17.9

Actual Duration (Months)

73.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Staphylococcus Aureus Orthopaedic Surgery Surgical Site Infection Prevention	Drug: Chlorhexidine, Lifo-Scrub sol 4%®, 500ml, B. Braun Drug: BACTROBAN® Nasal ong	Phase 4

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 Design

Study Type:

Interventional

Actual Enrollment :

1318 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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

Masking:

Double (Participant, Outcomes Assessor)

Masking Description:

Participants are not told colonization status or study arm. Outcome Assessor are not informed as well on this informations.

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Jan 1, 2019

Actual Primary Completion Date :

Mar 30, 2020

Actual Study Completion Date :

Jun 30, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

Surgical site infections [2 years]
according CDC-Criteria

Secondary Outcome Measures

Overall mortality [2 years]
Death related to infection [2 years]
Documented bacteria [2 years]
of PJI
Time to PJI and death [2 years]
counting from operation date

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sonnenhofspital, Lindenhofgruppe	Bern		Switzerland	3006

Sponsors and Collaborators

Lindenhofgruppe AG

Investigators

Principal Investigator: Jan Brügger, MD, Lindenhofgruppe

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Lindenhofgruppe AG

ClinicalTrials.gov Identifier:

NCT03962907

Other Study ID Numbers:

DECO-SSI P 2

First Posted:

May 24, 2019

Last Update Posted:

Jul 17, 2020

Last Verified:

Oct 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Infections

Communicable Diseases

Surgical Wound Infection

Chlorhexidine

Mupirocin

Study Results

No Results Posted as of Jul 17, 2020