Bacterial InfectionPhase 3ORAL-ISONCT02753387
Effect of Oral Preparation on Bacterial Colonization of the Pharyngeal Mucosa in Surgery of Head and Neck Cancer
A Phase 3 study testing Chlorhexidine and NaCl 0.9 % in people with Bacterial Infection, run by Rennes University Hospital at 1 site in France.
Trial summary
Surgical site infections are an important health indicator for hospitals and a significant medico-economic issue. The aim of the study is to assess the impact of chlorhexidine mouthwash performed before surgery on the bacterial colonization of the pharyngeal mucosa. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bacterial Infection
- What is being tested?
- Chlorhexidine and NaCl 0.9 %
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteFrance
- Study dates
- 23 May 2016to 5 Sep 2018
- Phase
- Phase 3
- 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
- Histological evidence of cancer regardless of histological type
- Surgical treatment requiring mucosal effraction regardless of the surgical approach;
- Patient over 18 years old;
- Oral cancer, oropharyngeal cancer, hypopharyngeal cancer or laryngeal cancer;
- Written and informed patient consent
Who cannot join
- Concomitant Vascular Interventions;
- Interventional radiology;
- Needing of second surgery at a same location during the 30 postoperative days);
- Cancer of the paranasal sinus, nasal cavity, skull base, salivary glands, skin,
- Neck dissection without mucosal effraction
- Thyroid or parathyroid surgery
Show all 10Show fewer
- Size tumor forbidden tumor surgery
- Allergy to any tested product;
- Concurrent infection the day before or day of surgery
- Protected adults (guardianship) and persons deprived of liberty
Trial locations and contacts
1 site in 1 country.
About this study
Surgical site infections are an important health indicator for hospitals and a significant medico-economic issue.
The aim of the study is to assess the impact of chlorhexidine mouthwash performed before surgery on the bacterial colonization of the pharyngeal mucosa.
Read the detailed description
The main objective is to reduce the number of patients with significant pathogenic bacterial colonization for pharyngeal mucosa at the end of the surgery. Oral flora is the same as the pharyngeal flora, so this suggests that the action of the oral mouthwash may also act in pharyngeal mucosa by buccopharyngeal communication.
Patients will be randomized into two groups :
- preoperative oral preparation with sodium chloride (NaCl) 0.9% (control group)
- preoperative oral preparation with chlorhexidine (experimental group)
A quantitative and qualitative analysis will be performed from samples collected during the surgery : before mouthwash (T0), after mouthwash (T1), before intubation in the operating room (T2), after intubation (T3), before incision (T4) and just before the end of the intervention on the mucosal scar (T5)
- Conditions
- Bacterial Infection
- Being tested
- Chlorhexidine, NaCl 0.9 %
- Keywords
- mouthwash, head and neck cancer, chlorhexidine, pathogens germs
- Medical subject headings
- Bacterial Infections, Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChlorhexidineDrug
Also called Eludril Perio
4 mouthwashes during 30 seconds with Eludril Perio 10 ml and 1 application after intubation with Eludril Perio
NaCl 0.9 %Device
4 mouthwashes during 30 seconds with NaCl 0.9 % 10 ml and 1 application after intubation with NaCl 0.9 %
| Study group | Role | What they receive |
|---|---|---|
| CHLORHEXIDINE | Experimental | Patients will receive 1 preoperative oral preparation and 1 peroperative oral preparation of chlorhexidine Receives: Drug: Chlorhexidine |
| NaCl 0.9 % | Placebo comparator | Patients will receive 1 preoperative oral preparation and 1 peroperative oral preparation of NaCl 0.9% Receives: Device: NaCl 0.9 % |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients with pharyngeal mucosa colonization (>=10^2 Colony Forming Unit (CFU)/ml of pathogen germs of the oral flora) at the end of the surgery
The percentage of patients with pharyngeal mucosa colonization will be determined from the sample collected on the mucosal scar just before the end of the surgery (T5)
Measured: The day of the surgery
Secondary outcomes (8)
Number of patients with a significant rate of pathogen germs (>=10^2 CFU/ml) at T1
The number of patients with a significant rate of pathogen germs will be determined from the sample collected after mouthwash (T1)
Measured: The day of the surgery
Type of oral germs
The type of germs will be determined for all the samples collected during the surgery (i.e. before mouthwash (T0), after mouthwash (T1), before intubation in the operating room (T2), after intubation (T3), before incision (T4) and just before the end of the intervention on the mucosal scar (T5))
Measured: The day of the surgery
Number of positive cultures of pathogen germs
The number of positive cultures of pathogen germs will be determined for all the samples collected during the surgery (i.e. before mouthwash (T0), after mouthwash (T1), before intubation in the operating room (T2), after intubation (T3), before incision (T4) and just before the end of the intervention on the mucosal scar (T5))
Measured: The day of the surgery
Kinetics of the number of CFU/ml
The kinetics of the number of CFU/ml will be determined from all the samples collected during the surgery (i.e. before mouthwash (T0), after mouthwash (T1), before intubation in the operating room (T2), after intubation (T3), before incision (T4) and just before the end of the intervention on the mucosal scar (T5))
Measured: The day of the surgery
Number of CFU/ml of pathogens germs
The number of CFU/ml of pathogens germs will be determined for all the samples collected during the surgery (i.e. before mouthwash (T0), after mouthwash (T1), before intubation in the operating room (T2), after intubation (T3), before incision (T4) and just before the end of the intervention on the mucosal scar (T5))
Measured: The day of the surgery
Surgical site infections rate in the postoperative month (standard definition of the Centers for Disease Control and Prevention, Atlanta)
Measured: 30 days
Number of patients who processed correctly preoperative mouthwash
Measured: The day of the surgery
Change in the number of CFU/ml of pathogen germs before and after intubation (T2-T3)
The change in the number of CFU/ml of pathogen germs will be assessed using the samples collected before (T2) and after intubation (T3)
Measured: The day of the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2016 (estimated)
- Study start23 May 2016
- Primary completion5 Sep 2018
- Study completion5 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bacterial InfectionStudies of the same condition, open and under way.
- More trials run by Rennes University HospitalThe 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Franck JEGOUX, PH, Principal investigator, Rennes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02753387
- Sponsor's protocol ID
- 35RC15_8923_ORAL-ISO
- Acronym
- ORAL-ISO
- Status last verified
- Dec 2018
- First submitted
- 13 Apr 2016
- Last updated
- 20 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Oral Preparation on Bacterial Colonization of the Pharyngeal Mucosa in Surgery of Head and Neck Cancer
- ClinicalTrials.gov ID
- NCT02753387
- Acronym / sponsor ID
- ORAL-ISO / 35RC15_8923_ORAL-ISO
- Conditions
- Bacterial Infection
- Keywords
- mouthwash, head and neck cancer, chlorhexidine, pathogens germs
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- 23 May 2016 (actual)
- Primary completion
- 5 Sep 2018 (actual)
- Study completion
- 5 Sep 2018 (actual)
- First posted
- 27 Apr 2016 (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 an important health indicator for hospitals and a significant medico-economic issue.
The aim of the study is to assess the impact of chlorhexidine mouthwash performed before surgery on the bacterial colonization of the pharyngeal mucosa.
Detailed description
The main objective is to reduce the number of patients with significant pathogenic bacterial colonization for pharyngeal mucosa at the end of the surgery. Oral flora is the same as the pharyngeal flora, so this suggests that the action of the oral mouthwash may also act in pharyngeal mucosa by buccopharyngeal communication.
Patients will be randomized into two groups :
- preoperative oral preparation with sodium chloride (NaCl) 0.9% (control group)
- preoperative oral preparation with chlorhexidine (experimental group)
A quantitative and qualitative analysis will be performed from samples collected during the surgery : before mouthwash (T0), after mouthwash (T1), before intubation in the operating room (T2), after intubation (T3), before incision (T4) and just before the end of the intervention on the mucosal scar (T5)
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CHLORHEXIDINE | Experimental | Drug: ChlorhexidinePatients will receive 1 preoperative oral preparation and 1 peroperative oral preparation of chlorhexidine |
| NaCl 0.9 % | Placebo comparator | Device: NaCl 0.9 %Patients will receive 1 preoperative oral preparation and 1 peroperative oral preparation of NaCl 0.9% |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Histological evidence of cancer regardless of histological type
- Surgical treatment requiring mucosal effraction regardless of the surgical approach;
- Patient over 18 years old;
- Oral cancer, oropharyngeal cancer, hypopharyngeal cancer or laryngeal cancer;
- Written and informed patient consent
Key exclusion criteria (10 listed)
- Concomitant Vascular Interventions;
- Interventional radiology;
- Needing of second surgery at a same location during the 30 postoperative days);
- Cancer of the paranasal sinus, nasal cavity, skull base, salivary glands, skin,
- Neck dissection without mucosal effraction
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 |
|---|---|---|
| ChlorhexidineAlso: Eludril Perio4 mouthwashes during 30 seconds with Eludril Perio 10 ml and 1 application after intubation with Eludril Perio | Drug | CHLORHEXIDINE |
| NaCl 0.9 %4 mouthwashes during 30 seconds with NaCl 0.9 % 10 ml and 1 application after intubation with NaCl 0.9 % | Device | NaCl 0.9 % |
Primary outcome
Percentage of patients with pharyngeal mucosa colonization (>=10^2 Colony Forming Unit (CFU)/ml of pathogen germs of the oral flora) at the end of the surgery
Time frame: The day of the surgery
The percentage of patients with pharyngeal mucosa colonization will be determined from the sample collected on the mucosal scar just before the end of the surgery (T5)
8 secondary outcomes
Number of patients with a significant rate of pathogen germs (>=10^2 CFU/ml) at T1
Time frame: The day of the surgery
Type of oral germs
Time frame: The day of the surgery
Number of positive cultures of pathogen germs
Time frame: The day of the surgery
Kinetics of the number of CFU/ml
Time frame: The day of the surgery
Number of CFU/ml of pathogens germs
Time frame: The day of the surgery
Surgical site infections rate in the postoperative month (standard definition of the Centers for Disease Control and Prevention, Atlanta)
Time frame: 30 days
Number of patients who processed correctly preoperative mouthwash
Time frame: The day of the surgery
Change in the number of CFU/ml of pathogen germs before and after intubation (T2-T3)
Time frame: The day of the surgery
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 20 Dec 2018.
- Individual participant dataSharing planned: No
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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.
Franck JEGOUX, PH principal investigator
Rennes University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Chlorhexidine and NaCl 0.9 % in people with Bacterial Infection, run by Rennes University Hospital at 1 site in France.
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 10 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 20 Dec 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 France. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Percentage of patients with pharyngeal mucosa colonization (>=10^2 Colony Forming Unit (CFU)/ml of pathogen germs of the oral flora) at the end of the surgery (time frame: The day of the surgery). 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 20 Dec 2018.