Trial Outcomes & Findings for The Value of Home Chlorhexidine Pre-Surgical Wash Before Spine Surgery (NCT NCT02767427)
NCT ID: NCT02767427
Last Updated: 2023-02-06
Results Overview
All specimens were taken by a sterile BD E-Swab. All samples will be sent immediately after acquisition to the microbiology lab for analysis within four hours.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
40 participants
Primary outcome timeframe
Pre-Surgery and Post Surgery, up to 4 hours
Results posted on
2023-02-06
Participant Flow
Participant milestones
| Measure |
At-Home Chlorhexidine
Those randomized into the chlorhexidine group will be asked to shower the night before surgery, and to use a standardized pre-packaged Chlorhexidine Wipes (chlorhexidine gluconate wipes) on their surgical site after thoroughly drying those areas. They will be asked to use a second wipe in each area the morning of surgery. Those who forget to use the wipe in the morning were allowed to use the wipe in the pre-operative area and included if this occurs more than one hour before skin prep.
Chlorhexidine Wipes: (Standard of Care) Chlorhexidine wipes are a commonly used pre-operative skin cleansing measure, designed to reduce bacterial load on the skin of the surgical site.
|
No At-Home Chlorhexidine
Participants in this group will not use chlorhexidine wipes (no intervention), as is standard of care, prior to their surgical site being cleansed by the surgical team pre-operatively.
No intervention: Chlorhexidine wipes will not be used though it is a commonly used pre-operative skin cleansing measure.
|
|---|---|---|
|
Overall Study
STARTED
|
21
|
19
|
|
Overall Study
COMPLETED
|
21
|
19
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Value of Home Chlorhexidine Pre-Surgical Wash Before Spine Surgery
Baseline characteristics by cohort
| Measure |
At-Home Chlorhexidine
n=21 Participants
Those randomized into the chlorhexidine group will be asked to shower the night before surgery, and to use a standardized pre-packaged Chlorhexidine Wipes (chlorhexidine gluconate (CHG) wipes) on their surgical site after thoroughly drying those areas. They will be asked to use a second wipe in each area the morning of surgery. Those who forget to use the wipe in the morning were allowed to use the wipe in the pre-operative area and included if this occurs more than one hour before skin prep.
Chlorhexidine Wipes: (Standard of Care) Chlorhexidine wipes are a commonly used pre-operative skin cleansing measure, designed to reduce bacterial load on the skin of the surgical site.
|
No At-Home Chlorhexidine
n=19 Participants
Participants in this group will not use chlorhexidine wipes (no intervention), as is standard of care, prior to their surgical site being cleansed by the surgical team pre-operatively.
No intervention: Chlorhexidine wipes will not be used though it is a commonly used pre-operative skin cleansing measure.
|
Total
n=40 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
|
18 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Age, Continuous
|
56.05 years
STANDARD_DEVIATION 9.12 • n=5 Participants
|
59.79 years
STANDARD_DEVIATION 13.10 • n=7 Participants
|
57.87 years
STANDARD_DEVIATION 11.39 • n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
27 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
|
2 Participants
n=7 Participants
|
2 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
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
19 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
33 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
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
21 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Pre-Surgery and Post Surgery, up to 4 hoursAll specimens were taken by a sterile BD E-Swab. All samples will be sent immediately after acquisition to the microbiology lab for analysis within four hours.
Outcome measures
| Measure |
At-Home Chlorhexidine
n=21 Participants
Those randomized into the chlorhexidine group will be asked to shower the night before surgery, and to use a standardized pre-packaged Chlorhexidine Wipes (chlorhexidine gluconate wipes) on their surgical site after thoroughly drying those areas. They will be asked to use a second wipe in each area the morning of surgery. Those who forget to use the wipe in the morning were allowed to use the wipe in the pre-operative area and included if this occurs more than one hour before skin prep.
Chlorhexidine Wipes: (Standard of Care) Chlorhexidine wipes are a commonly used pre-operative skin cleansing measure, designed to reduce bacterial load on the skin of the surgical site.
|
No At-Home Chlorhexidine
n=19 Participants
Participants in this group will not use chlorhexidine wipes (no intervention), as is standard of care, prior to their surgical site being cleansed by the surgical team pre-operatively.
No intervention: Chlorhexidine wipes will not be used though it is a commonly used pre-operative skin cleansing measure.
|
|---|---|---|
|
Number of Patients With Cutaneous Bacterial Load After Surgery
Presurgery Bacterial Colony Count · Subjects with bacterial colonies
|
0 Participants
|
18 Participants
|
|
Number of Patients With Cutaneous Bacterial Load After Surgery
Presurgery Bacterial Colony Count · Subjects without bacterial colonies
|
21 Participants
|
1 Participants
|
|
Number of Patients With Cutaneous Bacterial Load After Surgery
Postsurgical Bacterial Colony Count · Subjects with bacterial colonies
|
0 Participants
|
0 Participants
|
|
Number of Patients With Cutaneous Bacterial Load After Surgery
Postsurgical Bacterial Colony Count · Subjects without bacterial colonies
|
21 Participants
|
19 Participants
|
Adverse Events
At-Home Chlorhexidine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
No At-Home Chlorhexidine
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
Dr. Kiehyun Daniel Riew, Professor of Orthopedic Surgery
Columbia University
Phone: 212-932-4410
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place