Wound Infection Due to Staphylococcus AureusPhase 4NCT02182115
S. Aureus Screening and Decolonization
A Phase 4 study testing antiseptic bundle in people with Wound Infection Due to Staphylococcus Aureus and MRSA Infection of Postoperative Wound, run by University of Minnesota at 1 site in United States.
Trial summary
Staphylococcus aureus (SA) healthcare-associated infections (HAI) cause significant morbidity and mortality. SA causes 15% of all HAI and 30% of surgical site infections (SSIs). Each year over 40 million Americans undergo operations, 1-10% of whom will acquire SSIs. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Wound Infection Due to Staphylococcus Aureus, MRSA Infection of Postoperative Wound
- What is being tested?
- antiseptic bundle
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2014to Aug 2016
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All patient who are 18 years and older, able to give informed consent and willing to complete the study decolonization protocol.
- Surgery must be scheduled 2 weeks in the future to allow completion of the study protocol prior to the scheduled operation.
- Patients will be admitted from home the day of the surgery or have the surgery done on an outpatient basis.
Who cannot join
- Currently on antibiotic therapy, allergy to mupirocin or CHG.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota Medical Center
Minneapolis, Minnesota, 55455
About this study
Official title: Effectiveness of Screening and Decolonization of S. Aureus in Surgery Outpatients
Staphylococcus aureus (SA) healthcare-associated infections (HAI) cause significant morbidity and mortality. SA causes 15% of all HAI and 30% of surgical site infections (SSIs). Each year over 40 million Americans undergo operations, 1-10% of whom will acquire SSIs. Such infections double the length of hospitalization and risk of dying, and increase U.S. health care costs by $5-10 billion/year. We need effective interventions to prevent SSIs caused by either methicillin-susceptible (MSSA) or methicillin-resistant (MRSA) strains. Nasal carriers of SA (25-30% of adults) have a 2-14 times greater risk than non-carriers of acquiring an SA SSI. A potential prevention approach is routine pre-operative screening of patients, followed by decolonization of identified SA carriers.
Read the detailed description
The long term goal of this research is to help reduce the incidence of SSIs caused by SA, both MSSA and MRSA strains. This will help improve the safety and effectiveness of health care for Americans. Achievement of this goal requires that we first address the following critical knowledge gaps: (i) which surgical patients should be screened pre-operatively; (ii) which body site(s) should be screened for optimal SA detection, and (iii) which decolonization approach is optimal for outpatient use. The goal of this study is to conduct the research needed to determine pre-operative SA carriage rates (including by strain type and site of carriage), to evaluate the practicality (adherence, cost) of a SA decolonization protocol that is self-administered by patients at home. We are conducting randomized clinical trial (RCT) of the efficacy of nasal mupirocin ointment, chlorhexidine gluconate (CHG) mouth rinse, and CHG pre-operative bathing, as performed by the patient at home for 5 days pre-operatively. This protocol will be compared with the current standard of care, usually 1-2 showers with an antiseptic soap before the procedure. Briefly, the aims are as follows:
Aim 1: Determine the efficacy of a novel decolonization protocol, compared with standard of care, for eradicating SA carriage pre-operatively in surgery out-patients. We hypothesize that the SA eradication rate will be 2-3 times higher in the intervention arm compared with the standard of care arm.
Aim 2: Obtain data to inform sample size calculations and cost estimates for a future trial to prevent SSIs, determine screening requirements, and assess treatment adherence. We will: determine the proportion of pre-operative patients who are SA carriers and the sites of carriage, by SA type, determine adherence to the study intervention and standard of care, reasons for non-compliance, and gather cost data to provide preliminary evidence of potential cost-effectiveness of the intervention.
Aim 3: Identify risk factors (demographic, medical) for SA carriage. Gather preliminary data on SSIs in study subjects.
- Being tested
- antiseptic bundle, standard of care
- Keywords
- Staphylococcus aureus infection, Decolonization, Surgical site infection
- Medical subject headings
- Staphylococcal Infections, Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
antiseptic bundleDrug
Also called Medications applied at home by patient for 5 days.
- Chlorhexidine gluconate liquid soap for bathing daily.
- Chlorhexidine gluconate mouthrinse to use twice daily.
- Nasal mupirocin to apply twice daily.
standard of careDrug
Also called Follow surgeon's instructions for pre-operative bathing.
Surgeon's instructions may include advising patients to use an antiseptic soap prior to surgery.
| Study group | Role | What they receive |
|---|---|---|
| standard of care | Active comparator | Surgeon's routine for preoperative showering. Receives: Drug: standard of care |
| antiseptic bundle | Experimental | Patients to use study bundle for 5 days prior to scheduled surgery with the following medications to use at home.
1. Chlorhexidine gluconate soap applied for bathing daily.
2. Chlorhexidine gluconate mouthrinse used to rinse mouth twice daily.
3. Nasal mupirocin to applied inside nostrils twice daily. Receives: Drug: antiseptic bundle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eradication of Staphylococcus Aureus (SA) Carriage at All 4 Body Sites Tested.
Participants with no SA post-treatment, proportion (%) of participants in each study arm that had no SA detected on the post-treatment cultures from the 4 body sites sampled with swab cultures.
Measured: Immediately prior to surgery patients are swabbed again at the 4 body sites to see if SA is present or not.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2014 (estimated)
- Study startJul 2014
- Primary completionAug 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Wound Infection Due to Staphylococcus AureusStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Responsible party
- Sponsor
- Investigators
- Susan E Kline, MD, MPH, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02182115
- Sponsor's protocol ID
- 1R03HS022912-01
- Other IDs
- 1R03HS022912-01
- Status last verified
- Nov 2019
- First submitted
- 1 Jul 2014
- Last updated
- 5 Nov 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No: Aggregate data will be reported once the study has been completed.
Publications
Kline SE, Neaton JD, Lynfield R, Ferrieri P, Kulasingam S, Dittes K, Glennen A, Jawahir S, Kaizer A, Menk J, Johnson JR. Randomized controlled trial of a self-administered five-day antiseptic bundle versus usual disinfectant soap showers for preoperative eradication of Staphylococcus aureus colonization. Infect Control Hosp Epidemiol. 2018 Sep;39(9):1049-1057. doi: 10.1017/ice.2018.151. Epub 2018 Jul 24.
PubMed 30037355
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Screening and Decolonization of S. Aureus in Surgery Outpatients
- ClinicalTrials.gov ID
- NCT02182115
- Acronym / sponsor ID
- 1R03HS022912-01
- Keywords
- Staphylococcus aureus infection, Decolonization, Surgical site infection
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Study start
- Jul 2014
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 8 Jul 2014 (estimated)
- Results
- Posted 17 Nov 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Staphylococcus aureus (SA) healthcare-associated infections (HAI) cause significant morbidity and mortality. SA causes 15% of all HAI and 30% of surgical site infections (SSIs). Each year over 40 million Americans undergo operations, 1-10% of whom will acquire SSIs. Such infections double the length of hospitalization and risk of dying, and increase U.S. health care costs by $5-10 billion/year. We need effective interventions to prevent SSIs caused by either methicillin-susceptible (MSSA) or methicillin-resistant (MRSA) strains. Nasal carriers of SA (25-30% of adults) have a 2-14 times greater risk than non-carriers of acquiring an SA SSI. A potential prevention approach is routine pre-operative screening of patients, followed by decolonization of identified SA carriers.
Detailed description
The long term goal of this research is to help reduce the incidence of SSIs caused by SA, both MSSA and MRSA strains. This will help improve the safety and effectiveness of health care for Americans. Achievement of this goal requires that we first address the following critical knowledge gaps: (i) which surgical patients should be screened pre-operatively; (ii) which body site(s) should be screened for optimal SA detection, and (iii) which decolonization approach is optimal for outpatient use. The goal of this study is to conduct the research needed to determine pre-operative SA carriage rates (including by strain type and site of carriage), to evaluate the practicality (adherence, cost) of a SA decolonization protocol that is self-administered by patients at home. We are conducting randomized clinical trial (RCT) of the efficacy of nasal mupirocin ointment, chlorhexidine gluconate (CHG) mouth rinse, and CHG pre-operative bathing, as performed by the patient at home for 5 days pre-operatively. This protocol will be compared with the current standard of care, usually 1-2 showers with an antiseptic soap before the procedure. Briefly, the aims are as follows:
Aim 1: Determine the efficacy of a novel decolonization protocol, compared with standard of care, for eradicating SA carriage pre-operatively in surgery out-patients. We hypothesize that the SA eradication rate will be 2-3 times higher in the intervention arm compared with the standard of care arm.
Aim 2: Obtain data to inform sample size calculations and cost estimates for a future trial to prevent SSIs, determine screening requirements, and assess treatment adherence. We will: determine the proportion of pre-operative patients who are SA carriers and the sites of carriage, by SA type, determine adherence to the study intervention and standard of care, reasons for non-compliance, and gather cost data to provide preliminary evidence of potential cost-effectiveness of the intervention.
Aim 3: Identify risk factors (demographic, medical) for SA carriage. Gather preliminary data on SSIs in study subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| standard of care | Active comparator | Drug: standard of careSurgeon's routine for preoperative showering. |
| antiseptic bundle | Experimental | Drug: antiseptic bundlePatients to use study bundle for 5 days prior to scheduled surgery with the following medications to use at home. 1. Chlorhexidine gluconate soap applied for bathing daily. 2. Chlorhexidine gluconate mouthrinse used to rinse mouth twice daily. 3. Nasal mupirocin to applied inside nostrils twice daily. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- All patient who are 18 years and older, able to give informed consent and willing to complete the study decolonization protocol.
- Surgery must be scheduled 2 weeks in the future to allow completion of the study protocol prior to the scheduled operation.
- Patients will be admitted from home the day of the surgery or have the surgery done on an outpatient basis.
Key exclusion criteria (1 listed)
- Currently on antibiotic therapy, allergy to mupirocin or CHG.
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 |
|---|---|---|
| antiseptic bundleAlso: Medications applied at home by patient for 5 days.1. Chlorhexidine gluconate liquid soap for bathing daily. 2. Chlorhexidine gluconate mouthrinse to use twice daily. 3. Nasal mupirocin to apply twice daily. | Drug | antiseptic bundle |
| standard of careAlso: Follow surgeon's instructions for pre-operative bathing.Surgeon's instructions may include advising patients to use an antiseptic soap prior to surgery. | Drug | standard of care |
Primary outcome
Eradication of Staphylococcus Aureus (SA) Carriage at All 4 Body Sites Tested.
Time frame: Immediately prior to surgery patients are swabbed again at the 4 body sites to see if SA is present or not.
Participants with no SA post-treatment, proportion (%) of participants in each study arm that had no SA detected on the post-treatment cultures from the 4 body sites sampled with swab cultures.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30037355Kline SE, Neaton JD, Lynfield R, Ferrieri P, Kulasingam S, Dittes K, Glennen A, Jawahir S, Kaizer A, Menk J, Johnson JR. Randomized controlled trial of a self-administered five-day antiseptic bundle versus usual disinfectant soap showers for preoperative eradication of Staphylococcus aureus colonization. Infect Control Hosp Epidemiol. 2018 Sep;39(9):1049-1057. doi: 10.1017/ice.2018.151. Epub 2018 Jul 24.
- Individual participant dataSharing planned: No. Aggregate data will be reported once the study has been completed.
Related trials for Wound Infection Due to Staphylococcus Aureus
Not yet recruitingObservational study
Gene Expression Analysis of Biofilm Formation and Antimicrobial Resistance in Clinical Methicillin-Resistant Staphylococcus Aureus
Staphylococcal Aureus Infection, Surgical Site Infection (SSI)
Active, not recruitingPhase 4
PVI to Prevent S. Aureus SSI After Fixation of HELEF (POTENT Study)
Surgical Site Infection
RecruitingObservational study
Effectiveness of Screening and Decolonization of S. Aureus to Prevent S. Aureus Surgical Site Infections in Surgery Outpatients
Staphylococcus Aureus Colonization, Surgical Site Infections
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.
Susan E Kline, MD, MPH principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing antiseptic bundle in people with Wound Infection Due to Staphylococcus Aureus and MRSA Infection of Postoperative Wound, run by University of Minnesota at 1 site in United States.
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 3 inclusion and 1 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 5 Nov 2019. 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 United States. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Nov 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Eradication of Staphylococcus Aureus (SA) Carriage at All 4 Body Sites Tested. (time frame: Immediately prior to surgery patients are swabbed again at the 4 body sites to see if SA is present or not.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02182115, which also lists 1 linked publication.
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 5 Nov 2019.