Trial Outcomes & Findings for Visibility of Site Marking for Surgical Time Out With Two Different Skin Preparation Solutions (NCT NCT00739583)
NCT ID: NCT00739583
Last Updated: 2013-07-10
Results Overview
The number of correctly identified initials as viewed by the orthopaedic surgeons. 10 participants were randomized to each study group. Each patient was marked with three initials. Each was viewed by ten surgeons giving a total of 300 initials for each group.
COMPLETED
PHASE4
20 participants
at time of surgery, approximately 10 minutes
2013-07-10
Participant Flow
Participant milestones
| Measure |
Chlorhexidine Group
Skin preparation for hip replacement with a Chlorhexidine based skin preparation solution, Chloraprep® (CHG 2% w/v and IPA 70% v/v; Enturia Inc., Leawood, KS, USA)
|
Iodine Group
Skin preparation for hip replacement with an Iodine based skin preparation solution, Duraprep® (Iodophor 0.7% and IPA 74% w/w; 3M Healthcare, St. Paul, MN, USA.
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
|
Overall Study
COMPLETED
|
10
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Visibility of Site Marking for Surgical Time Out With Two Different Skin Preparation Solutions
Baseline characteristics by cohort
| Measure |
Chlorhexidine Group
n=10 Participants
Skin preparation for hip replacement with a Chlorhexidine based skin preparation solution, Chloraprep® (CHG 2% w/v and IPA 70% v/v; Enturia Inc., Leawood, KS, USA)
|
Iodine Group
n=10 Participants
Skin preparation for hip replacement with an Iodine based skin preparation solution, Duraprep® (Iodophor 0.7% and IPA 74% w/w; 3M Healthcare, St. Paul, MN, USA.
|
Total
n=20 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
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Age Continuous
|
71 years
STANDARD_DEVIATION 4.6 • n=5 Participants
|
73 years
STANDARD_DEVIATION 4.2 • n=7 Participants
|
72 years
STANDARD_DEVIATION 4.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=5 Participants
|
10 participants
n=7 Participants
|
20 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: at time of surgery, approximately 10 minutesThe number of correctly identified initials as viewed by the orthopaedic surgeons. 10 participants were randomized to each study group. Each patient was marked with three initials. Each was viewed by ten surgeons giving a total of 300 initials for each group.
Outcome measures
| Measure |
Chlorhexidine Group
n=300 number of random initials
Skin preparation for hip replacement with a Chlorhexidine based skin preparation solution, Chloraprep® (CHG 2% w/v and IPA 70% v/v; Enturia Inc., Leawood, KS, USA)
|
Iodine Group
n=300 number of random initials
Skin preparation for hip replacement with an Iodine based skin preparation solution, Duraprep® (Iodophor 0.7% and IPA 74% w/w; 3M Healthcare, St. Paul, MN, USA.
|
|---|---|---|
|
Identification of the Random Initials by the Reviewing Orthopaedic Surgeons
|
209 number of correctly identified initals
|
296 number of correctly identified initals
|
SECONDARY outcome
Timeframe: at time of surgery, approximately ten minutesThe Mean change in gray level of the ink line as expressed in units between pre and post skin preparation. Gray level is a unitless value from 0-255 describing the brightness of a pixel (0 being black and 255 being white).
Outcome measures
| Measure |
Chlorhexidine Group
n=10 change in gray level
Skin preparation for hip replacement with a Chlorhexidine based skin preparation solution, Chloraprep® (CHG 2% w/v and IPA 70% v/v; Enturia Inc., Leawood, KS, USA)
|
Iodine Group
n=10 change in gray level
Skin preparation for hip replacement with an Iodine based skin preparation solution, Duraprep® (Iodophor 0.7% and IPA 74% w/w; 3M Healthcare, St. Paul, MN, USA.
|
|---|---|---|
|
The Mean Change in Gray Level (Contrast) of the Horizontal Line
|
59.8 gray level units
Standard Deviation 59.8
|
14.9 gray level units
Standard Deviation 11.4
|
SECONDARY outcome
Timeframe: at time of surgery, approximately ten minutesThe number of sets of initials judged by the viewing orthopedic surgeons as sufficient for adequate site identification. Each participant was labeled with three initials to simulate a surgeon's initials. Ten orthopaedic surgeons determined if the initials were visible enough to allow for site identification. Each surgeon viewed all of the sets of initials, resulting in 100 viewed sets of initials in each group.
Outcome measures
| Measure |
Chlorhexidine Group
n=100 sets of initials
Skin preparation for hip replacement with a Chlorhexidine based skin preparation solution, Chloraprep® (CHG 2% w/v and IPA 70% v/v; Enturia Inc., Leawood, KS, USA)
|
Iodine Group
n=100 sets of initials
Skin preparation for hip replacement with an Iodine based skin preparation solution, Duraprep® (Iodophor 0.7% and IPA 74% w/w; 3M Healthcare, St. Paul, MN, USA.
|
|---|---|---|
|
Judgment of Reviewing Orthopaedic Surgeons That the Site Marking is Identifiable for Them to Perform Site Identification
|
56 sets of intials
|
95 sets of intials
|
Adverse Events
Chlorhexidine Group
Iodine Group
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