Methicillin-resistant Staphylococcus AureusNCT03886623
A Systematic Oral Care Program in Post-Mechanically Ventilated, Post-Intensive Care Patients
A study testing 4-day systematic oral hygiene in people with Methicillin-resistant Staphylococcus Aureus and Methicillin-Sensitive Staphylococcus Aureus Infection, run by Ohio State University at 1 site in United States.
Trial summary
The purpose of this study is to see if a 4 day oral care program in patients who have been on a breathing machine results in better oral health, reduces the amount of certain bacteria in the mouth and reduces infection while in the hospital. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Methicillin-resistant Staphylococcus Aureus, Methicillin-Sensitive Staphylococcus Aureus Infection
- What is being tested?
- 4-day systematic oral hygiene
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2011to Dec 2013
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or older
- Has required mechanical ventilation for at least 48 hours
- Meets ventilator liberation criteria (PEEP ≤ 8 and FiO2 ≤ 50%)
- Minimum of 3 teeth
- Either the subject or their Legally Authorized Representative is capable of reading, understanding and providing written informed consent.
Who cannot join
- Non-English speaking
- Allergy to products/components of the oral care protocol
- Oral or maxillofacial surgery, or oral/facial trauma in last three months
- INR > 3.5 or platelet count < 20,000
- Planned hospital discharge within 48 hours
- Current diagnosis of mucositis, or undergoing chemotherapy or radiation therapy
Show all 9Show fewer
- Presence of Tracheostomy
- Family or physician not in favor of continued medical treatment.
- Unable to give informed consent, and/or lack of availability of an authorized representative who can provide consent
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to see if a 4 day oral care program in patients who have been on a breathing machine results in better oral health, reduces the amount of certain bacteria in the mouth and reduces infection while in the hospital.
The plan is to test the specific hypotheses that a standardized oral care protocol:
- Results in improved oral health compared to standard care,
- Reduces the rate of Staphylococcus aureus / methicillin resistant Staphylococcus aureus, and
- Reduces the risk of healthcare-associated infections.
Read the detailed description
Upon meeting inclusion criteria and consenting to participate, the subject will be enrolled in the study. Upon extubation, the subject will be randomly assigned using a computer generated table of random numbers to either the intervention or control group. Daily safety checks including reviewing INR and platelet counts (if performed) will be performed to ensure patient has maintained eligibility for the study.
Study Intervention:
Control Arm:
Current practice in the intensive care units includes the provision of oral care as part of the Ventilator Bundle guideline focused on the reduction of VAP. Currently, the intensive care units utilize a commercially available pre-package oral hygiene kit. This includes mouth care (alcohol free mouthrinse and hydrogen peroxide) with swabs every 2 hours, tooth brushing (suction toothbrush with anti- plaque paste) every 12 hours, deep oral suctioning every 8 hours and prior to ET tube retaping, and chlorohexidine gluconate (15ml) swabbed onto oral surfaces every 12 hours (SICU patients only). Mouth care is documented every two hours.
On the progressive care units and general medical-surgical units, routine oral care is provided as part of the general hygiene care of the units, and based on the clinical determination of the nurse. The selection of oral care techniques currently used on the progressive care units is determined by the level of independence of the patient and oral hygiene needs of the patient. Two techniques are currently being implemented: 1) toothbrushing using a basic toothbrush and basic oral care products provided by the hospital every 12- 24 hours. 2) The prepackaged suctioning kit which includes suction toothbrush with toothpaste and suction oral swabs with alcohol-free mouth rinse, and hydrogen peroxide every 4 hours or based on clinical judgement. Lip moisturizer is applied inside the mouth and on the lips.
Intervention Arm The intervention proposed would include a 4-5 day systematic oral hygiene program provided to patients who are post-extubation. The proposed intervention would begin in the intensive care unit within 24 hours post-extubation and when the patient is determined to be medically stable. The protocol would be initiated with an intensive oral hygiene intervention (see Appendix A) with selected oral hygiene products in the post-extubation period. Following the oral hygiene intervention of the oral cavity, the intervention would continue even if the patient transitions from the intensive care setting to either the progressive care unit or general medical-surgical unit. The intervention will be provided by the Clinical Nurse Specialist (key personnel) from the Division of Critical Care Nursing and Medical-Surgical Nursing. The oral hygiene program will be provided a total of 9 times.
- Conditions
- Methicillin-resistant Staphylococcus Aureus, Methicillin-Sensitive Staphylococcus Aureus Infection
- Being tested
- 4-day systematic oral hygiene, Standard of Care oral care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
4-day systematic oral hygieneProcedure or surgery
he intervention proposed would include a 4-5 day systematic oral hygiene program. Using a pea-sized amount of Colgate Total Clean Mint Toothpaste with a Battery-operated Oral-B Pro-Health Type 3744 toothbrush, all surfaces, tongue-side, check-side, and biting surfaces of the participants teeth will be brushed. The tongue will be brushed with a GUM Dual Action Tongue Cleaner and flossing will be done with GUM Flossmate handle and Oral B Guide Floss in between the contacts of each tooth. The mouth will then be rinsed with Crest Pro-Health mouthwash rinse for 30 seconds twice daily. A Medline Remedy Phytoplex lip balm will then be applied.
Standard of Care oral careOther
Standard of Care oral care. Currently, the intensive care units utilize a commercially available pre-package oral hygiene kit. This includes mouthwash swabbing every 2 hours with Careline Alcohol-Free mouthwash or Sage Alcohol Free mouthwash, teeth brushing (with Sage Toothette Oral Care, Sodium Bicarbonate Toothpaste and Sage Suction Toothbrush) every 12 hours, deep oral suctioning every 8 hours and prior to oral Endotracheal tube (ET) retaping, and Paroex Oral Rinse chlorohexidine gluconate (15ml) swabbed onto oral surfaces every 12 hours (SICU patients only). Mouth care is documented every two hours.
| Study group | Role | What they receive |
|---|---|---|
| 4-day systematic oral hygiene | Experimental | The intervention proposed would include a 4-5 day systematic oral hygiene program. Using a pea-sized amount of Colgate Total Clean Mint Toothpaste with a Battery-operated Oral-B Pro-Health Type 3744 toothbrush, all surfaces, tongue-side, check-side, and biting surfaces of the participants teeth will be brushed. The tongue will be brushed with a GUM Dual Action Tongue Cleaner and flossing will be done with GUM Flossmate handle and Oral B Guide Floss in between the contacts of each tooth. The mouth will then be rinsed with Crest Pro-Health mouthwash rinse for 30 seconds twice daily. A Medline Remedy Phytoplex lip balm will then be applied. Receives: Procedure: 4-day systematic oral hygiene |
| Standard of Care oral care | Other | Standard of Care oral care. Currently, the intensive care units utilize a commercially available pre-package oral hygiene kit. This includes mouthwash swabbing every 2 hours with Careline Alcohol-Free mouthwash or Sage Alcohol Free mouthwash, teeth brushing (with Sage Toothette Oral Care, Sodium Bicarbonate Toothpaste and Sage Suction Toothbrush) every 12 hours, deep oral suctioning every 8 hours and prior to oral Endotracheal tube (ET) retaping, and Paroex Oral Rinse chlorohexidine gluconate (15ml) swabbed onto oral surfaces every 12 hours (SICU patients only). Mouth care is documented every two hours. Receives: Other: Standard of Care oral care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in prevalence of Methicillin-sensitive Staphylococcus aureus (MSSA) in post mechanically ventilated patients as assessed by Oral cultures (Swabs)
The overall purpose of this project is to develop an evidence-based oral care protocol for acutely ill hospitalized patients and determine the impact of this protocol on health outcomes in recently extubated patients. The aim is to assess the impact of an oral care protocol on the following rate of oral colonization with Methicillin-sensitive Staphylococcus aureus (MSSA)
Measured: Day 1 and 4 days post-extubation
Change in prevalence of Methicillin-resistant Staphylococcus aureus (MRSA) in post mechanically ventilated patients as assessed by Oral cultures (Swabs)
The overall purpose of this project is to develop an evidence-based oral care protocol for acutely ill hospitalized patients and determine the impact of this protocol on health outcomes in recently extubated patients. The aim is to assess the impact of an oral care protocol on the following rate of MRSA,
Measured: Day 1 and 4 days post-extubation
Secondary outcomes (3)
Determine infection rate of healthcare acquired infections (MSSA and MRSA) in post mechanically ventilated patients receiving oral care using nasal cultures (Swabs)
Obtain Data on the incidence of new MSSA and MRSA infections in the post-mechanically, ventilated post-ICU patient using nasal cultures (Swabs)
Measured: 4 days
Identify change in patient satisfaction in post mechanically ventilated patients who receive oral care using a Patient satisfaction survey/interview.
Assess whether there is an increase in patient satisfaction in those receiving the intervention by using Patient satisfaction survey/interview.
Measured: 4 days post extubation
Identify change in patient quality of life in post mechanically ventilated patients who receive oral care using the Edmonton Symptom Assessment System quality of life assessment tool.
Measure change in patient quality of life as reported using the Edmonton Symptom Assessment System quality of life assessment tool of 0 to 10 scale, where 0 represents no symptom and 10 represents the worst possible severity.
Measured: 4 days post extubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2019
- Study startJun 2011
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Methicillin-resistant Staphylococcus AureusStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esther Chipps, Ohio State University
- Investigators
- Esther Chipps, RN,PhD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03886623
- Sponsor's protocol ID
- 2011H0015
- Status last verified
- Mar 2019
- First submitted
- 9 Oct 2012
- Last updated
- 22 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Systematic Oral Care Program in Post-Mechanically Ventilated, Post-Intensive Care Patients
- ClinicalTrials.gov ID
- NCT03886623
- Acronym / sponsor ID
- 2011H0015
- Conditions
- Methicillin-resistant Staphylococcus Aureus, Methicillin-Sensitive Staphylococcus Aureus Infection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 22 Mar 2019 (actual)
- 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.
The purpose of this study is to see if a 4 day oral care program in patients who have been on a breathing machine results in better oral health, reduces the amount of certain bacteria in the mouth and reduces infection while in the hospital.
The plan is to test the specific hypotheses that a standardized oral care protocol:
- Results in improved oral health compared to standard care,
- Reduces the rate of Staphylococcus aureus / methicillin resistant Staphylococcus aureus, and
- Reduces the risk of healthcare-associated infections.
Detailed description
Upon meeting inclusion criteria and consenting to participate, the subject will be enrolled in the study. Upon extubation, the subject will be randomly assigned using a computer generated table of random numbers to either the intervention or control group. Daily safety checks including reviewing INR and platelet counts (if performed) will be performed to ensure patient has maintained eligibility for the study.
Study Intervention:
Control Arm:
Current practice in the intensive care units includes the provision of oral care as part of the Ventilator Bundle guideline focused on the reduction of VAP. Currently, the intensive care units utilize a commercially available pre-package oral hygiene kit. This includes mouth care (alcohol free mouthrinse and hydrogen peroxide) with swabs every 2 hours, tooth brushing (suction toothbrush with anti- plaque paste) every 12 hours, deep oral suctioning every 8 hours and prior to ET tube retaping, and chlorohexidine gluconate (15ml) swabbed onto oral surfaces every 12 hours (SICU patients only). Mouth care is documented every two hours.
On the progressive care units and general medical-surgical units, routine oral care is provided as part of the general hygiene care of the units, and based on the clinical determination of the nurse. The selection of oral care techniques currently used on the progressive care units is determined by the level of independence of the patient and oral hygiene needs of the patient. Two techniques are currently being implemented: 1) toothbrushing using a basic toothbrush and basic oral care products provided by the hospital every 12- 24 hours. 2) The prepackaged suctioning kit which includes suction toothbrush with toothpaste and suction oral swabs with alcohol-free mouth rinse, and hydrogen peroxide every 4 hours or based on clinical judgement. Lip moisturizer is applied inside the mouth and on the lips.
Intervention Arm The intervention proposed would include a 4-5 day systematic oral hygiene program provided to patients who are post-extubation. The proposed intervention would begin in the intensive care unit within 24 hours post-extubation and when the patient is determined to be medically stable. The protocol would be initiated with an intensive oral hygiene intervention (see Appendix A) with selected oral hygiene products in the post-extubation period. Following the oral hygiene intervention of the oral cavity, the intervention would continue even if the patient transitions from the intensive care setting to either the progressive care unit or general medical-surgical unit. The intervention will be provided by the Clinical Nurse Specialist (key personnel) from the Division of Critical Care Nursing and Medical-Surgical Nursing. The oral hygiene program will be provided a total of 9 times.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 4-day systematic oral hygiene | Experimental | Procedure: 4-day systematic oral hygieneThe intervention proposed would include a 4-5 day systematic oral hygiene program. Using a pea-sized amount of Colgate Total Clean Mint Toothpaste with a Battery-operated Oral-B Pro-Health Type 3744 toothbrush, all surfaces, tongue-side, check-side, and biting surfaces of the participants teeth will be brushed. The tongue will be brushed with a GUM Dual Action Tongue Cleaner and flossing will be done with GUM Flossmate handle and Oral B Guide Floss in between the contacts of each tooth. The mouth will then be rinsed with Crest Pro-Health mouthwash rinse for 30 seconds twice daily. A Medline Remedy Phytoplex lip balm will then be applied. |
| Standard of Care oral care | Other | Other: Standard of Care oral careStandard of Care oral care. Currently, the intensive care units utilize a commercially available pre-package oral hygiene kit. This includes mouthwash swabbing every 2 hours with Careline Alcohol-Free mouthwash or Sage Alcohol Free mouthwash, teeth brushing (with Sage Toothette Oral Care, Sodium Bicarbonate Toothpaste and Sage Suction Toothbrush) every 12 hours, deep oral suctioning every 8 hours and prior to oral Endotracheal tube (ET) retaping, and Paroex Oral Rinse chlorohexidine gluconate (15ml) swabbed onto oral surfaces every 12 hours (SICU patients only). Mouth care is documented every two hours. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18 years or older
- Has required mechanical ventilation for at least 48 hours
- Meets ventilator liberation criteria (PEEP ≤ 8 and FiO2 ≤ 50%)
- Minimum of 3 teeth
- Either the subject or their Legally Authorized Representative is capable of reading, understanding and providing written informed consent.
Key exclusion criteria (9 listed)
- Non-English speaking
- Allergy to products/components of the oral care protocol
- Oral or maxillofacial surgery, or oral/facial trauma in last three months
- INR > 3.5 or platelet count < 20,000
- Planned hospital discharge within 48 hours
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 |
|---|---|---|
| 4-day systematic oral hygienehe intervention proposed would include a 4-5 day systematic oral hygiene program. Using a pea-sized amount of Colgate Total Clean Mint Toothpaste with a Battery-operated Oral-B Pro-Health Type 3744 toothbrush, all surfaces, tongue-side, check-side, and biting surfaces of the participants teeth will be brushed. The tongue will be brushed with a GUM Dual Action Tongue Cleaner and flossing will be done with GUM Flossmate handle and Oral B Guide Floss in between the contacts of each tooth. The mouth will then be rinsed with Crest Pro-Health mouthwash rinse for 30 seconds twice daily. A Medline Remedy Phytoplex lip balm will then be applied. | Procedure or surgery | 4-day systematic oral hygiene |
| Standard of Care oral careStandard of Care oral care. Currently, the intensive care units utilize a commercially available pre-package oral hygiene kit. This includes mouthwash swabbing every 2 hours with Careline Alcohol-Free mouthwash or Sage Alcohol Free mouthwash, teeth brushing (with Sage Toothette Oral Care, Sodium Bicarbonate Toothpaste and Sage Suction Toothbrush) every 12 hours, deep oral suctioning every 8 hours and prior to oral Endotracheal tube (ET) retaping, and Paroex Oral Rinse chlorohexidine gluconate (15ml) swabbed onto oral surfaces every 12 hours (SICU patients only). Mouth care is documented every two hours. | Other | Standard of Care oral care |
Primary outcome
Change in prevalence of Methicillin-sensitive Staphylococcus aureus (MSSA) in post mechanically ventilated patients as assessed by Oral cultures (Swabs)
Time frame: Day 1 and 4 days post-extubation
The overall purpose of this project is to develop an evidence-based oral care protocol for acutely ill hospitalized patients and determine the impact of this protocol on health outcomes in recently extubated patients. The aim is to assess the impact of an oral care protocol on the following rate of oral colonization with Methicillin-sensitive Staphylococcus aureus (MSSA)
Change in prevalence of Methicillin-resistant Staphylococcus aureus (MRSA) in post mechanically ventilated patients as assessed by Oral cultures (Swabs)
Time frame: Day 1 and 4 days post-extubation
The overall purpose of this project is to develop an evidence-based oral care protocol for acutely ill hospitalized patients and determine the impact of this protocol on health outcomes in recently extubated patients. The aim is to assess the impact of an oral care protocol on the following rate of MRSA,
3 secondary outcomes
Determine infection rate of healthcare acquired infections (MSSA and MRSA) in post mechanically ventilated patients receiving oral care using nasal cultures (Swabs)
Time frame: 4 days
Identify change in patient satisfaction in post mechanically ventilated patients who receive oral care using a Patient satisfaction survey/interview.
Time frame: 4 days post extubation
Identify change in patient quality of life in post mechanically ventilated patients who receive oral care using the Edmonton Symptom Assessment System quality of life assessment tool.
Time frame: 4 days post extubation
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 22 Mar 2019.
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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.
Esther Chipps, RN,PhD principal investigator
Ohio State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 4-day systematic oral hygiene in people with Methicillin-resistant Staphylococcus Aureus and Methicillin-Sensitive Staphylococcus Aureus Infection, run by Ohio State University 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 5 inclusion and 9 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 22 Mar 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.
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?
Change in prevalence of Methicillin-sensitive Staphylococcus aureus (MSSA) in post mechanically ventilated patients as assessed by Oral cultures (Swabs) (time frame: Day 1 and 4 days post-extubation). The study lists 2 primary outcomes in all. 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 22 Mar 2019.