Back to results

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

Primary Purpose

Orthopedic Disorders, Surgical Site Infection

Status

Completed

Phase

Not Applicable

Locations

Switzerland

Study Type

Interventional

Intervention

Mupirocin 2% nasal ointement

Chlorhexidine sol 4%

About this trial

This is an interventional prevention trial for Orthopedic Disorders focused on measuring Orthopedic surgery, Surgical site infection, Decolonization, Staphylococcus aureus

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Sonnenhofspital, Lindenhofgruppe

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

No Intervention

Active Comparator

No Intervention

Active Comparator

Arm Label

Nose-SA-carriers control

Nose-SA-carriers decolonized

Non-nose-SA-carriers control

Non-nose-carriers decolonized

Arm Description

Control Group, no intervention

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

Control Group, no intervention

Chlorhexidine sol 4% shower, daily for 5 days preoperatively

Outcomes

Primary Outcome Measures

Overall number of participants with surgical site infections 3 months postoperatively

Phone interview and orthopedic assessement

Secondary Outcome Measures

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

Phone interview and orthopedic assessement

Full Information

NCT ID

NCT02560155

First Posted

September 16, 2015

Last Updated

February 26, 2018

Sponsor

Lindenhofgruppe AG

Collaborators

Clinical Trials Unit Bern (CTU), Lindenhofstiftung, Labormedizinisches Zentrum Dr. Risch

1. Study Identification

Unique Protocol Identification Number

NCT02560155

Brief Title

Preoperative Decolonization and Surgical Site Infections - a Prospective Randomized Trial

Acronym

DECO-SSI

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2018

Overall Recruitment Status

Completed

Study Start Date

November 2015 (Actual)

Primary Completion Date

October 2017 (Actual)

Study Completion Date

February 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Lindenhofgruppe AG

Collaborators

Clinical Trials Unit Bern (CTU), Lindenhofstiftung, Labormedizinisches Zentrum Dr. Risch

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Orthopedic Disorders, Surgical Site Infection

Keywords

Orthopedic surgery, Surgical site infection, Decolonization, Staphylococcus aureus

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

1300 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Nose-SA-carriers control

Arm Type

No Intervention

Arm Description

Control Group, no intervention

Arm Title

Nose-SA-carriers decolonized

Arm Type

Active Comparator

Arm Description

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

Arm Title

Non-nose-SA-carriers control

Arm Type

No Intervention

Arm Description

Control Group, no intervention

Arm Title

Non-nose-carriers decolonized

Arm Type

Active Comparator

Arm Description

Chlorhexidine sol 4% shower, daily for 5 days preoperatively

Intervention Type

Drug

Intervention Name(s)

Mupirocin 2% nasal ointement

Other Intervention Name(s)

Bactroban Nasal

Intervention Description

Mupirocin nasal ointement 2x/d for 5 days preoperatively

Intervention Type

Drug

Intervention Name(s)

Chlorhexidine sol 4%

Other Intervention Name(s)

Lifo-Scrub sol 4%

Intervention Description

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

Primary Outcome Measure Information:

Title

Overall number of participants with surgical site infections 3 months postoperatively

Description

Phone interview and orthopedic assessement

Time Frame

3 months

Secondary Outcome Measure Information:

Title

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

Description

Phone interview and orthopedic assessement

Time Frame

1 and 3 months

Other Pre-specified Outcome Measures:

Title

Total screening costs

Description

Total screening costs divided by the number of prevented SSI to assess cost-effectiveness

Time Frame

one year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

16 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jan Brügger, Dr. med.

Organizational Affiliation

Lindenhofgruppe AG

Official's Role

Principal Investigator

Facility Information:

Facility Name

Sonnenhofspital, Lindenhofgruppe

City

Bern

ZIP/Postal Code

3006

Country

Switzerland

12. IPD Sharing Statement

Learn more about this trial

Preoperative Decolonization and Surgical Site Infections - a Prospective Randomized Trial

We'll reach out to this number within 24 hrs