Trial Outcomes & Findings for Use of 2% Chlorhexidine Cloths Reduce Surgical Site Infections (NCT NCT02385708)

NCT ID: NCT02385708

Last Updated: 2019-04-30

Results Overview

Number of participants who had surgical site infection development at 30 day post operative visit based on Center for Disease Control Criteria for Defining A Surgical Site Infection (SSI), 2011.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 163 participants
• Primary outcome timeframe: 30 days
• Results posted on: 2019-04-30

Participant Flow

Participant milestones

Measure	Standard of Care Patients will perform the current standard of care treatment using 2% Chlorohexidine Gluconate Cloths on the abdomen and buttocks prior to colorectal surgery night before surgery and morning of surgery 2% Chlorohexidine Gluconate: Use of 2% Chlorhexidine cloths chin to toes daily	Treatment Arm Patients will receive detailed instruction for use of 2% Chlorohexidine Gluconate cloths chin to toe night before and morning of surgery then daily post operative till discharge 2% Chlorohexidine Gluconate: Use of 2% Chlorhexidine cloths chin to toes daily
Overall Study STARTED	81	82
Overall Study Intervention Started	81	82
Overall Study COMPLETED	73	67
Overall Study NOT COMPLETED	8	15

Reasons for withdrawal

Measure	Standard of Care Patients will perform the current standard of care treatment using 2% Chlorohexidine Gluconate Cloths on the abdomen and buttocks prior to colorectal surgery night before surgery and morning of surgery 2% Chlorohexidine Gluconate: Use of 2% Chlorhexidine cloths chin to toes daily	Treatment Arm Patients will receive detailed instruction for use of 2% Chlorohexidine Gluconate cloths chin to toe night before and morning of surgery then daily post operative till discharge 2% Chlorohexidine Gluconate: Use of 2% Chlorhexidine cloths chin to toes daily
Overall Study Withdrawal by Subject	0	2
Overall Study Withdrawn - surgery canceled	2	5
Overall Study Investigator decision	5	7
Overall Study Protocol Violation	1	1

Baseline Characteristics

Use of 2% Chlorhexidine Cloths Reduce Surgical Site Infections

Baseline characteristics by cohort

Measure	Standard of Care n=73 Participants Patients will perform the current standard of care treatment using 2% Chlorohexidine Gluconate Cloths on the abdomen and buttocks prior to colorectal surgery night before surgery and morning of surgery 2% Chlorohexidine Gluconate: Use of 2% Chlorhexidine cloths chin to toes daily	Treatment Arm n=67 Participants Patients will receive detailed instruction for use of 2% Chlorohexidine Gluconate cloths chin to toe night before and morning of surgery then daily post operative till discharge 2% Chlorohexidine Gluconate: Use of 2% Chlorhexidine cloths chin to toes daily	Total n=140 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	48 Participants n=5 Participants	39 Participants n=7 Participants	87 Participants n=5 Participants
Age, Categorical >=65 years	25 Participants n=5 Participants	28 Participants n=7 Participants	53 Participants n=5 Participants
Sex: Female, Male Female	26 Participants n=5 Participants	24 Participants n=7 Participants	50 Participants n=5 Participants
Sex: Female, Male Male	47 Participants n=5 Participants	43 Participants n=7 Participants	90 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	72 Participants n=5 Participants	67 Participants n=7 Participants	139 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	8 Participants n=5 Participants	1 Participants n=7 Participants	9 Participants n=5 Participants
Race (NIH/OMB) White	65 Participants n=5 Participants	66 Participants n=7 Participants	131 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	73 participants n=5 Participants	67 participants n=7 Participants	140 participants n=5 Participants

PRIMARY outcome

Timeframe: 30 days

Number of participants who had surgical site infection development at 30 day post operative visit based on Center for Disease Control Criteria for Defining A Surgical Site Infection (SSI), 2011.

Outcome measures

Measure	Standard of Care n=73 Participants Patients will perform the current standard of care treatment using 2% Chlorohexidine Gluconate Cloths on the abdomen and buttocks prior to colorectal surgery night before surgery and morning of surgery 2% Chlorohexidine Gluconate: Use of 2% Chlorhexidine cloths chin to toes daily	Treatment Arm n=67 Participants Patients will receive detailed instruction for use of 2% Chlorohexidine Gluconate cloths chin to toe night before and morning of surgery then daily post operative till discharge 2% Chlorohexidine Gluconate: Use of 2% Chlorhexidine cloths chin to toes daily
Incidence of Surgical Site Infections	0 Participants	0 Participants

Adverse Events

Standard of Care

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

Treatment Arm

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Measure	Standard of Care n=81 participants at risk Patients will perform the current standard of care treatment using 2% Chlorohexidine Gluconate Cloths on the abdomen and buttocks prior to colorectal surgery night before surgery and morning of surgery 2% Chlorohexidine Gluconate: Use of 2% Chlorhexidine cloths chin to toes daily	Treatment Arm n=82 participants at risk Patients will receive detailed instruction for use of 2% Chlorohexidine Gluconate cloths chin to toe night before and morning of surgery then daily post operative till discharge 2% Chlorohexidine Gluconate: Use of 2% Chlorhexidine cloths chin to toes daily
Gastrointestinal disorders Anastomotic leak	1.2% 1/81 • Number of events 1 • From one day prior to surgery to post operative day 4	0.00% 0/82 • From one day prior to surgery to post operative day 4

Other adverse events

Measure	Standard of Care n=81 participants at risk Patients will perform the current standard of care treatment using 2% Chlorohexidine Gluconate Cloths on the abdomen and buttocks prior to colorectal surgery night before surgery and morning of surgery 2% Chlorohexidine Gluconate: Use of 2% Chlorhexidine cloths chin to toes daily	Treatment Arm n=82 participants at risk Patients will receive detailed instruction for use of 2% Chlorohexidine Gluconate cloths chin to toe night before and morning of surgery then daily post operative till discharge 2% Chlorohexidine Gluconate: Use of 2% Chlorhexidine cloths chin to toes daily
Nervous system disorders Acute altered mental status change	0.00% 0/81 • From one day prior to surgery to post operative day 4	1.2% 1/82 • Number of events 1 • From one day prior to surgery to post operative day 4
Gastrointestinal disorders nausea/vomiting/dehydration	0.00% 0/81 • From one day prior to surgery to post operative day 4	1.2% 1/82 • Number of events 1 • From one day prior to surgery to post operative day 4
Skin and subcutaneous tissue disorders skin rash and itching	0.00% 0/81 • From one day prior to surgery to post operative day 4	1.2% 1/82 • Number of events 1 • From one day prior to surgery to post operative day 4
Cardiac disorders new onset atrial fibrillation with rapid ventricular response	1.2% 1/81 • Number of events 1 • From one day prior to surgery to post operative day 4	0.00% 0/82 • From one day prior to surgery to post operative day 4
Cardiac disorders persistent tachycardia with hemodynamic instability	1.2% 1/81 • Number of events 1 • From one day prior to surgery to post operative day 4	0.00% 0/82 • From one day prior to surgery to post operative day 4

Additional Information

Steven Klintworth

Vanderbilt University Medical Center

Phone: 615-936-3298

Email: steven.klintworth@vumc.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place