Orthopedic DisordersDECO-SSINCT02560155
Preoperative Decolonization and Surgical Site Infections - a Prospective Randomized Trial
A study testing Mupirocin 2% nasal ointement and Chlorhexidine sol 4% in people with Orthopedic Disorders and Surgical Site Infection, run by Lindenhofgruppe AG at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Orthopedic Disorders, Surgical Site Infection
- What is being tested?
- Mupirocin 2% nasal ointement and Chlorhexidine sol 4%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,300 participants
- Where
- 1 siteSwitzerland
- Study dates
- Nov 2015to Feb 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- patient older than 16 years
- patient undergoing elective orthopedic procedure at the Sonnenhof hospital
- decolozination protocol can be performed timely
- signed informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Preoperative Decolonization and Surgical Site Infections - a Prospective Randomized Trial (DECO-SSI Trial)
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.
Read the 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.
- Conditions
- Orthopedic Disorders, Surgical Site Infection
- Being tested
- Mupirocin 2% nasal ointement, Chlorhexidine sol 4%
- Keywords
- Orthopedic surgery, Surgical site infection, Decolonization, Staphylococcus aureus
- Medical subject headings
- Musculoskeletal Diseases, Surgical Wound Infection, Staphylococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mupirocin 2% nasal ointementDrug
Also called Bactroban Nasal
Mupirocin nasal ointement 2x/d for 5 days preoperatively
Chlorhexidine sol 4%Drug
Also called Lifo-Scrub sol 4%
Shower with Chlorhexidine sol 4% once a day for 5 days preoperatively
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Mupirocin 2% nasal ointement; Drug: 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 Receives: Drug: Chlorhexidine sol 4% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall number of participants with surgical site infections 3 months postoperatively
Phone interview and orthopedic assessement
Measured: 3 months
Secondary outcomes (1)
Number of participants with surgical site infections at 1 and 3 months postoperatively
Phone interview and orthopedic assessement
Measured: 1 and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2015 (estimated)
- Study startNov 2015
- Primary completionOct 2017
- Study completionFeb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orthopedic DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lindenhofgruppe AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Clinical Trials Unit Bern (CTU), Lindenhofstiftung, Labormedizinisches Zentrum Dr. Risch
- Responsible party
- Sponsor
- Investigators
- Jan Brügger, Dr. med., Principal investigator, Lindenhofgruppe AG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02560155
- Sponsor's protocol ID
- 14-11-F
- Acronym
- DECO-SSI
- Status last verified
- Feb 2018
- First submitted
- 16 Sep 2015
- Last updated
- 27 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Decolonization and Surgical Site Infections - a Prospective Randomized Trial (DECO-SSI Trial)
- ClinicalTrials.gov ID
- NCT02560155
- Acronym / sponsor ID
- DECO-SSI / 14-11-F
- Conditions
- Orthopedic Disorders, Surgical Site Infection
- Keywords
- Orthopedic surgery, Surgical site infection, Decolonization, Staphylococcus aureus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,300 participants (actual)
- Lead sponsor
- Lindenhofgruppe AGIndustry (pharma, biotech, devices)
- Collaborators
- Clinical Trials Unit Bern (CTU), Lindenhofstiftung, Labormedizinisches Zentrum Dr. Risch
- Study start
- Nov 2015 (actual)
- Primary completion
- Oct 2017 (actual)
- Study completion
- Feb 2018 (actual)
- First posted
- 25 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Nose-SA-carriers control | No intervention | –Control Group, no intervention |
| Nose-SA-carriers decolonized | Active comparator | Drug: Mupirocin 2% nasal ointement, Drug: Chlorhexidine sol 4%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 |
| Non-nose-SA-carriers control | No intervention | –Control Group, no intervention |
| Non-nose-carriers decolonized | Active comparator | Drug: Chlorhexidine sol 4%Chlorhexidine sol 4% shower, daily for 5 days preoperatively |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- patient older than 16 years
- patient undergoing elective orthopedic procedure at the Sonnenhof hospital
- decolozination protocol can be performed timely
- signed informed consent
Key exclusion criteria (7 listed)
- no orthopedic surgery planned
- allergy to mupirocin or chlorhexidine
- presence of a nasal foreign body
- no informed consent
- pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mupirocin 2% nasal ointementAlso: Bactroban NasalMupirocin nasal ointement 2x/d for 5 days preoperatively | Drug | Nose-SA-carriers decolonized |
| Chlorhexidine sol 4%Also: Lifo-Scrub sol 4%Shower with Chlorhexidine sol 4% once a day for 5 days preoperatively | Drug | Non-nose-carriers decolonized, Nose-SA-carriers decolonized |
Primary outcome
Overall number of participants with surgical site infections 3 months postoperatively
Time frame: 3 months
Phone interview and orthopedic assessement
1 secondary outcome
Number of participants with surgical site infections at 1 and 3 months postoperatively
Time frame: 1 and 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jan Brügger, Dr. med. principal investigator
Lindenhofgruppe AG
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mupirocin 2% nasal ointement and Chlorhexidine sol 4% in people with Orthopedic Disorders and Surgical Site Infection, run by Lindenhofgruppe AG at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall number of participants with surgical site infections 3 months postoperatively (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2018.