Topical Antisepsis
Conditions
Keywords
antimicrobial, antisepsis
Brief summary
Compare 2 application techniques of ChloraPrep Swabstick--3 swabsticks at once versus 3 swabsticks used sequentially. Hibiclens applied according to the manufacturer's directions. Sterile swabsticks (wetted with sterile deionizd water) applied using the same method as the ChloraPrep Swabstick.
Detailed description
Determine differences (if any) in 2 different application techniques of ChloraPrep Swabstick--3 swabsticks at once versus 3 swabsticks used sequentially. Hibiclens, a liquid antibacterial soap, applied according to the manufacturer's directions as a active/positive comparison. Sterile swabsticks (wetted with sterile deionized water) applied as a negative comparison using the same method as the ChloraPrep swabstick. Study uses topical sampling from the abdomen and the groin on intact skin and evaluates the germs left on the skin after treatment with ChloraPrep Swabsticks.
Interventions
DRUGCHG 2% w/v & IPA 70% v/v, swabstick (3 @ once).
3 swabsticks topically applied at the same time to intact skin
DRUGCHG 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.
DRUGAqueous 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.
OTHERSterile swabstick with sterile water (3 @ once)
3 sterile swabsticks wetted with sterile water topically applied to intact skin at the same time.
OTHERSterile swabstick with sterile water (one-at-a-time)
Sterile swabsticks wetted with sterile water topically applied to intact skin one-at-a-time.
Sponsors
C. R. Bard
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Subjects must read and sign an Informed Consent Form and be cooperative. * Subjects must be in good general health. * Subjects must have skin within 6 inches of the test site that is free of tattoos, dermatoses, abrasions, cuts, lesions, or other skin disorders.
Exclusion criteria
* Use of systemic or topical antimicrobials during the 2-week pretest conditioning period. This restriction includes but is not limited to shampoos, lotions, soaps, baby powders, and materials, such as solvents, acids, or alkalis. * A medical diagnosis of a physical condition, which would preclude participation such as: diabetes, hepatitis, an organ transplant, a medical surgical implant, or an immunocompromised system. * Any medical condition that in the opinion of the investigator would preclude participation. * Bathed in chemically treated pools or hot tubs 2 weeks prior to any microbial sampling. * Used UV tanning lamps 2 weeks prior to any microbial sampling. * Bathing or showering less than 48 hours prior to any microbial sampling. * Known sensitivity to chlorhexidine gluconate. * Known sensitivity to latex (rubber). * Known sensitivity to fragrances. * Pregnant or nursing. * Unwillingness to fulfill the performance requirements of the study. * Subjects who have completed part or all of the study will not be reentered in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| log10 Reductions From Baseline for Each Test Parameter in CFU (Colony Forming Unit)/cm2 on Inguinal and Abdominal Sites | 10 minutes and 6 hours after application of test solutions | 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. |
Countries
United States
Participant flow
Pre-assignment details
Each subject received more than one treatment. Randomization was done by testing site and each subject had 4 testing sites.
Participants by arm
| Arm | Count |
|---|---|
| All Study Participants All Participants Who Completed Evaluations | 335 |
| Total | 335 |
Baseline characteristics
| Characteristic | All Study Participants |
|---|---|
| 371-121 Preoperative Skin Preparations CHG Swabstick (3 @ Once) | 139 Participants |
| 371-121 Preoperative Skin Preparations CHG Swabstick (Sequential) | 138 Participants |
| 371-121 Preoperative Skin Preparations Hibiclens | 133 Participants |
| 371-121 Preoperative Skin Preparations Sterile Water Swab (3 @ Once) | 132 Participants |
| 371-121 Preoperative Skin Preparations Sterile Water Swabstick (Sequential) | 126 Participants |
| Age, Continuous | 34.9 years STANDARD_DEVIATION 14.1 |
| Sex: Female, Male All Participants Female | 149 Participants |
| Sex: Female, Male All Participants Male | 186 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 139 | 0 / 138 | 0 / 133 | 0 / 132 | 0 / 126 |
| other Total, other adverse events | 0 / 139 | 0 / 138 | 0 / 133 | 0 / 132 | 0 / 126 |
| serious Total, serious adverse events | 0 / 139 | 0 / 138 | 0 / 133 | 0 / 132 | 0 / 126 |
Outcome results
Primary
log10 Reductions From Baseline for Each Test Parameter in CFU (Colony Forming Unit)/cm2 on Inguinal and Abdominal Sites
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.
Time frame: 10 minutes and 6 hours after application of test solutions
Population: 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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CHG Swabstick (3 @ Once) | 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 |
| CHG Swabstick (3 @ Once) | 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 |
| CHG Swabstick (3 @ Once) | 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 0.5 |
| CHG Swabstick (3 @ Once) | 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 0.6 |
| CHG Swabstick Sequential | log10 Reductions From Baseline for Each Test Parameter in CFU (Colony Forming Unit)/cm2 on Inguinal and Abdominal Sites | Groin site - 10 minutes | 3.44 Average log10 reductions in CFU/cm2 | Standard Deviation 0.64 |
| CHG Swabstick Sequential | log10 Reductions From Baseline for Each Test Parameter in CFU (Colony Forming Unit)/cm2 on Inguinal and Abdominal Sites | Abdomen site - 6 hours | 2.39 Average log10 reductions in CFU/cm2 | Standard Deviation 0.64 |
| CHG Swabstick Sequential | log10 Reductions From Baseline for Each Test Parameter in CFU (Colony Forming Unit)/cm2 on Inguinal and Abdominal Sites | Groin site - 6 hours | 3.24 Average log10 reductions in CFU/cm2 | Standard Deviation 0.58 |
| CHG Swabstick Sequential | log10 Reductions From Baseline for Each Test Parameter in CFU (Colony Forming Unit)/cm2 on Inguinal and Abdominal Sites | Abdomen site - 10 minutes | 2.58 Average log10 reductions in CFU/cm2 | Standard Deviation 0.48 |
| Hibiclens | log10 Reductions From Baseline for Each Test Parameter in CFU (Colony Forming Unit)/cm2 on Inguinal and Abdominal Sites | Abdomen site - 6 hours | 2.51 Average log10 reductions in CFU/cm2 | Standard Deviation 0.66 |
| Hibiclens | log10 Reductions From Baseline for Each Test Parameter in CFU (Colony Forming Unit)/cm2 on Inguinal and Abdominal Sites | Groin site - 6 hours | 2.89 Average log10 reductions in CFU/cm2 | Standard Deviation 0.62 |
| Hibiclens | log10 Reductions From Baseline for Each Test Parameter in CFU (Colony Forming Unit)/cm2 on Inguinal and Abdominal Sites | Abdomen site - 10 minutes | 2.76 Average log10 reductions in CFU/cm2 | Standard Deviation 0.49 |
| Hibiclens | log10 Reductions From Baseline for Each Test Parameter in CFU (Colony Forming Unit)/cm2 on Inguinal and Abdominal Sites | Groin site - 10 minutes | 3.15 Average log10 reductions in CFU/cm2 | Standard Deviation 0.53 |
| Sterile Water Swab (3 @ Once) | log10 Reductions From Baseline for Each Test Parameter in CFU (Colony Forming Unit)/cm2 on Inguinal and Abdominal Sites | Groin site - 10 minutes | 0.92 Average log10 reductions in CFU/cm2 | Standard Deviation 0.47 |
| Sterile Water Swab (3 @ Once) | log10 Reductions From Baseline for Each Test Parameter in CFU (Colony Forming Unit)/cm2 on Inguinal and Abdominal Sites | Groin site - 6 hours | 0.82 Average log10 reductions in CFU/cm2 | Standard Deviation 0.47 |
| Sterile Water Swab (3 @ Once) | log10 Reductions From Baseline for Each Test Parameter in CFU (Colony Forming Unit)/cm2 on Inguinal and Abdominal Sites | Abdomen site - 6 hours | 0.47 Average log10 reductions in CFU/cm2 | Standard Deviation 0.38 |
| Sterile Water Swab (3 @ Once) | log10 Reductions From Baseline for Each Test Parameter in CFU (Colony Forming Unit)/cm2 on Inguinal and Abdominal Sites | Abdomen site - 10 minutes | 0.54 Average log10 reductions in CFU/cm2 | Standard Deviation 0.37 |
| Sterile Water Swabstick (Sequential) | log10 Reductions From Baseline for Each Test Parameter in CFU (Colony Forming Unit)/cm2 on Inguinal and Abdominal Sites | Abdomen site - 6 hours | 0.46 Average log10 reductions in CFU/cm2 | Standard Deviation 0.39 |
| Sterile Water Swabstick (Sequential) | log10 Reductions From Baseline for Each Test Parameter in CFU (Colony Forming Unit)/cm2 on Inguinal and Abdominal Sites | Abdomen site - 10 minutes | 0.50 Average log10 reductions in CFU/cm2 | Standard Deviation 0.35 |
| Sterile Water Swabstick (Sequential) | log10 Reductions From Baseline for Each Test Parameter in CFU (Colony Forming Unit)/cm2 on Inguinal and Abdominal Sites | Groin site - 6 hours | 0.85 Average log10 reductions in CFU/cm2 | Standard Deviation 0.58 |
| Sterile Water Swabstick (Sequential) | log10 Reductions From Baseline for Each Test Parameter in CFU (Colony Forming Unit)/cm2 on Inguinal and Abdominal Sites | Groin site - 10 minutes | 0.97 Average log10 reductions in CFU/cm2 | Standard Deviation 0.55 |