Trial Outcomes & Findings for Test for Pre Operative Skin Preparations (NCT NCT00799812)
NCT ID: NCT00799812
Last Updated: 2025-12-11
Results Overview
The bacterial reductions achieved by the test products and the controls using 2 different application techniques at 10-minute and 6-hour sampling intervals for both groin and abdominal sites were evaluated.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
335 participants
Primary outcome timeframe
10 minutes and 6 hours after application of test solutions
Results posted on
2025-12-11
Participant Flow
Each subject received more than one treatment. Randomization was done by testing site and each subject had 4 testing sites.
Unit of analysis: Treated Sites
Participant milestones
| Measure |
All Study Participants
Study Participants that were treated
|
|---|---|
|
Overall Study
STARTED
|
335 1324
|
|
Overall Study
CHG Swabstick (3 @ Once)
|
139 276
|
|
Overall Study
CHG Swabstick Sequential
|
138 273
|
|
Overall Study
Hibiclens
|
133 264
|
|
Overall Study
Sterile Water Swab (3 @ Once)
|
132 260
|
|
Overall Study
Sterile Water Swabstick (Sequential)
|
126 251
|
|
Overall Study
COMPLETED
|
335 1324
|
|
Overall Study
NOT COMPLETED
|
0 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Test for Pre Operative Skin Preparations
Baseline characteristics by cohort
| Measure |
All Study Participants
n=335 Participants
All Participants Who Completed Evaluations
|
|---|---|
|
Age, Continuous
|
34.9 years
STANDARD_DEVIATION 14.1 • n=9 Participants
|
|
Sex: Female, Male
All Participants · Female
|
149 Participants
n=9 Participants
|
|
Sex: Female, Male
All Participants · Male
|
186 Participants
n=9 Participants
|
|
371-121 Preoperative Skin Preparations
CHG Swabstick (3 @ Once)
|
139 Participants
n=9 Participants
|
|
371-121 Preoperative Skin Preparations
CHG Swabstick (Sequential)
|
138 Participants
n=9 Participants
|
|
371-121 Preoperative Skin Preparations
Hibiclens
|
133 Participants
n=9 Participants
|
|
371-121 Preoperative Skin Preparations
Sterile Water Swab (3 @ Once)
|
132 Participants
n=9 Participants
|
|
371-121 Preoperative Skin Preparations
Sterile Water Swabstick (Sequential)
|
126 Participants
n=9 Participants
|
PRIMARY outcome
Timeframe: 10 minutes and 6 hours after application of test solutionsPopulation: Measure Analysis Population Description: Number analyzed is not equal to participants treated but rather equal to the number of treated sites for individuals who met the baseline bacterial load criteria on treatment day
The bacterial reductions achieved by the test products and the controls using 2 different application techniques at 10-minute and 6-hour sampling intervals for both groin and abdominal sites were evaluated.
Outcome measures
| Measure |
CHG Swabstick (3 @ Once)
n=276 Number of Sites Analyzed
Chlorhexidine gluconate (CHG) 2% w/v CHG/isopropyl alcohol (IPA) 70% v/v - 3 swabsticks applied @ same time
CHG 2% w/v \& IPA 70% v/v, swabstick (3 @ once).: 3 swabsticks topically applied at the same time to intact skin
|
CHG Swabstick Sequential
n=273 Number of Sites Analyzed
Chlorhexidine gluconate (CHG) 2% w/v and isopropyl alcohol (IPA) 70% v/v - 3 swabsticks applied sequentially
CHG 2% w/v \& IPA 70% v/v swab applied sequentially: Chlorhexidine gluconate 2% w/v and isopropyl alcohol 70% v/v; 3 swabsticks applied sequentially to intact skin.
|
Hibiclens
n=264 Number of Sites Analyzed
Chlorhexidine gluconate (CHG) 4% w/v in an aqueous base
Aqueous CHG 4% w/v applied according to mfr's directions: Chlorhexidine gluconate 4% w/v in an aqueous base applied according to mfr's directions. Step 1) 5 ml of Hibiclens applied to a sterile gauze pad. Step 2) Product applied to treatment area on intact skin for 2 minutes. Area dried with sterile towel or sterile gauze. Steps 1 and 2 repeated.
|
Sterile Water Swab (3 @ Once)
n=260 Number of Sites Analyzed
Sterile swabstick wetted with sterile deionized water - 3 swabsticks applied at the same time.
Sterile swabstick with sterile water (3 @ once): 3 sterile swabsticks wetted with sterile water topically applied to intact skin at the same time.
|
Sterile Water Swabstick (Sequential)
n=251 Number of Sites Analyzed
Sterile swabstick wetted with sterile water--3 swabsticks applied sequentially.
Sterile swabstick with sterile water (one-at-a-time): Sterile swabsticks wetted with sterile water topically applied to intact skin one-at-a-time.
|
|---|---|---|---|---|---|
|
log10 Reductions From Baseline for Each Test Parameter in CFU (Colony Forming Unit)/cm2 on Inguinal and Abdominal Sites
Groin site - 6 hours
|
3.22 Average log10 reductions in CFU/cm2
Standard Deviation 0.65
|
3.24 Average log10 reductions in CFU/cm2
Standard Deviation 0.58
|
2.89 Average log10 reductions in CFU/cm2
Standard Deviation 0.62
|
0.82 Average log10 reductions in CFU/cm2
Standard Deviation 0.47
|
0.85 Average log10 reductions in CFU/cm2
Standard Deviation 0.58
|
|
log10 Reductions From Baseline for Each Test Parameter in CFU (Colony Forming Unit)/cm2 on Inguinal and Abdominal Sites
Abdomen site - 10 minutes
|
2.56 Average log10 reductions in CFU/cm2
Standard Deviation 0.50
|
2.58 Average log10 reductions in CFU/cm2
Standard Deviation 0.48
|
2.76 Average log10 reductions in CFU/cm2
Standard Deviation 0.49
|
0.54 Average log10 reductions in CFU/cm2
Standard Deviation 0.37
|
0.50 Average log10 reductions in CFU/cm2
Standard Deviation 0.35
|
|
log10 Reductions From Baseline for Each Test Parameter in CFU (Colony Forming Unit)/cm2 on Inguinal and Abdominal Sites
Abdomen site - 6 hours
|
2.38 Average log10 reductions in CFU/cm2
Standard Deviation 0.60
|
2.39 Average log10 reductions in CFU/cm2
Standard Deviation 0.64
|
2.51 Average log10 reductions in CFU/cm2
Standard Deviation 0.66
|
0.47 Average log10 reductions in CFU/cm2
Standard Deviation 0.38
|
0.46 Average log10 reductions in CFU/cm2
Standard Deviation 0.39
|
|
log10 Reductions From Baseline for Each Test Parameter in CFU (Colony Forming Unit)/cm2 on Inguinal and Abdominal Sites
Groin site - 10 minutes
|
3.51 Average log10 reductions in CFU/cm2
Standard Deviation 0.62
|
3.44 Average log10 reductions in CFU/cm2
Standard Deviation 0.64
|
3.15 Average log10 reductions in CFU/cm2
Standard Deviation 0.53
|
0.92 Average log10 reductions in CFU/cm2
Standard Deviation 0.47
|
0.97 Average log10 reductions in CFU/cm2
Standard Deviation 0.55
|
Adverse Events
CHG Swabstick (3 @ Once)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
CHG Swabstick Sequential
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Hibiclens
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Sterile Water Swab (3 @ Once)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Sterile Water Swabstick (Sequential)
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