Trial Outcomes & Findings for Chlorhexidine Gluconate Oral Care for Adults Experiencing Trauma (NCT NCT01382446)

Last Updated: 2017-02-06

Results Overview

Examination of number of participants who do not develop oral bacteria and Ventilator Associated Pneumonia when an oral rinse containing 0.12% Chlorhexidine Gluconate is used as part of a oral care protocol.

Recruitment status

COMPLETED

Study phase

Target enrollment

66 participants

Primary outcome timeframe

18 Months

Results posted on

2017-02-06

Participant Flow

Patients were recruited upon arrival to the Intensive Care Unit, or after mechanical ventilation was initiated.

Patients were randomized into groups after enrollment.

Participant milestones

Participant milestones
Measure	Standard Oral Care Regimen Toothpaste : Brushing the teeth, tongue, gingiva, and oral mucosa twice daily with toothbrush and toothpaste.	Chlorhexidine Oral Care Regimen Chlorhexidine gluconate : 0.12% Chlorhexidine Gluconate 15ml Twice Daily, administered via toothbrushing and swabbing teeth, tongue, gingiva, and oral mucosa.
Overall Study STARTED	33	33
Overall Study COMPLETED	30	29
Overall Study NOT COMPLETED	3	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Standard Oral Care Regimen Toothpaste : Brushing the teeth, tongue, gingiva, and oral mucosa twice daily with toothbrush and toothpaste.	Chlorhexidine Oral Care Regimen Chlorhexidine gluconate : 0.12% Chlorhexidine Gluconate 15ml Twice Daily, administered via toothbrushing and swabbing teeth, tongue, gingiva, and oral mucosa.
Overall Study Withdrawal by Subject	0	1
Overall Study Removal from Mechanical Ventilation	3	3

Baseline Characteristics

Chlorhexidine Gluconate Oral Care for Adults Experiencing Trauma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Standard Oral Care Regimen n=33 Participants Toothpaste : Brushing the teeth, tongue, gingiva, and oral mucosa twice daily with toothbrush and toothpaste.	Chlorhexidine Oral Care Regimen n=33 Participants Chlorhexidine gluconate : 0.12% Chlorhexidine Gluconate 15ml Twice Daily, administered via toothbrushing and swabbing teeth, tongue, gingiva, and oral mucosa.	Total n=66 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	32 Participants n=5 Participants	25 Participants n=7 Participants	57 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	8 Participants n=7 Participants	9 Participants n=5 Participants
Age, Continuous	41.5 years STANDARD_DEVIATION 16.279 • n=5 Participants	45.5 years STANDARD_DEVIATION 19.96 • n=7 Participants	43.88 years STANDARD_DEVIATION 18.355 • n=5 Participants
Gender Female	11 Participants n=5 Participants	8 Participants n=7 Participants	19 Participants n=5 Participants
Gender Male	22 Participants n=5 Participants	25 Participants n=7 Participants	47 Participants n=5 Participants
Region of Enrollment United States	33 participants n=5 Participants	33 participants n=7 Participants	66 participants n=5 Participants

PRIMARY outcome

Timeframe: 18 Months

Population: Intention to Treat Analysis Used

Outcome measures

Outcome measures
Measure	Standard Oral Care Regimen n=33 Participants Toothpaste : Brushing the teeth, tongue, gingiva, and oral mucosa twice daily with toothbrush and toothpaste.	Chlorhexidine Oral Care Regimen n=33 Participants Chlorhexidine gluconate : 0.12% Chlorhexidine Gluconate 15ml Twice Daily, administered via toothbrushing and swabbing teeth, tongue, gingiva, and oral mucosa.
Effectiveness of Chlorhexidine Gluconate Oral Care for Trauma Patients	30 participants	29 participants

Adverse Events

Standard Oral Care Regimen

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Chlorhexidine Oral Care Regimen

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Tracy L. Thomas MSN RN CCRN ACNS-BC

SJHMC

Phone: 602-406-2567

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place