Trial Outcomes & Findings for 2% Chlorhexidine Gluconate Skin Cloths to Prevent SSI in Spine Surgery Patients (NCT NCT02490631)
NCT ID: NCT02490631
Last Updated: 2021-01-06
Results Overview
Evaluation daily using the CDC guidelines, daily measurements and deidentified photos
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
158 participants
Primary outcome timeframe
post op day 30
Results posted on
2021-01-06
Participant Flow
One participant signed consent, was randomized to the chlorhexidine arm, but their surgery was cancelled, so they did not start the study. There is no data for this subject.
Participant milestones
| Measure |
Standard of Care Pre-operative Cleansing
Standard of care pre-operative cleansing with soap and water the night before and morning of surgery
|
2% Chlorhexidine Gluconate
2% chlorhexidine gluconate cloths the night before and morning of surgery
2% chlorhexidine gluconate cloths: Cleansing twice pre-operatively jawline to toes with 2% chlorhexidine gluconate cloths
|
|---|---|---|
|
Overall Study
STARTED
|
79
|
78
|
|
Overall Study
COMPLETED
|
76
|
75
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Standard of Care Pre-operative Cleansing
n=76 Participants
Standard of care pre-operative cleansing with soap and water the night before and morning of surgery
|
2% Chlorhexidine Gluconate
n=75 Participants
2% chlorhexidine gluconate cloths the night before and morning of surgery
2% chlorhexidine gluconate cloths: Cleansing twice pre-operatively jawline to toes with 2% chlorhexidine gluconate cloths
|
Total
n=151 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63 years
n=76 Participants
|
66 years
n=75 Participants
|
64 years
n=151 Participants
|
|
Sex: Female, Male
Female
|
40 Participants
n=76 Participants
|
34 Participants
n=75 Participants
|
74 Participants
n=151 Participants
|
|
Sex: Female, Male
Male
|
36 Participants
n=76 Participants
|
41 Participants
n=75 Participants
|
77 Participants
n=151 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
76 participants
n=76 Participants
|
75 participants
n=75 Participants
|
151 participants
n=151 Participants
|
PRIMARY outcome
Timeframe: post op day 30Evaluation daily using the CDC guidelines, daily measurements and deidentified photos
Outcome measures
| Measure |
Standard of Care Pre-operative Cleansing
n=76 Participants
Standard of care pre-operative cleansing with soap and water the night before and morning of surgery
|
2% Chlorhexidine Gluconate
n=75 Participants
2% chlorhexidine gluconate cloths the night before and morning of surgery
2% chlorhexidine gluconate cloths: Cleansing twice pre-operatively jawline to toes with 2% chlorhexidine gluconate cloths
|
|---|---|---|
|
Participants With Surgical Site Infection Development at 30 Days Post-operative
|
5 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Day of Surgery, Day of Discharge, 30 days post-opSkin swabs collected on Day of Surgery, Day of Discharge, 30 days post-op
Outcome measures
| Measure |
Standard of Care Pre-operative Cleansing
n=76 Participants
Standard of care pre-operative cleansing with soap and water the night before and morning of surgery
|
2% Chlorhexidine Gluconate
n=75 Participants
2% chlorhexidine gluconate cloths the night before and morning of surgery
2% chlorhexidine gluconate cloths: Cleansing twice pre-operatively jawline to toes with 2% chlorhexidine gluconate cloths
|
|---|---|---|
|
Number of Participants With Positive or Abnormal Skin Cultures on Day of Surgery, Day of Discharge, 30 Days Post-op
day of surgery
|
41 Participants
|
7 Participants
|
|
Number of Participants With Positive or Abnormal Skin Cultures on Day of Surgery, Day of Discharge, 30 Days Post-op
day of discharge
|
21 Participants
|
9 Participants
|
|
Number of Participants With Positive or Abnormal Skin Cultures on Day of Surgery, Day of Discharge, 30 Days Post-op
30 days post-op
|
32 Participants
|
25 Participants
|
Adverse Events
Standard of Care Pre-operative Cleansing
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
2% Chlorhexidine Gluconate
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place