Surgical Site Infection
Conditions
Keywords
Preventative
Brief summary
Comparative study of antimicrobial effectiveness evaluation of of 26ml Project X, 10.5ml Project X, 5.1ml Project X and Prevantics Maxi swabstick following ASTM E1173 - Standard test method for evaluation of preoperative, precatheterization or preinjection skin preparations.
Interventions
DRUGIsopropyl alcohol & Chlorhexidine Gluconate Antiseptic
Application of antiseptic drug to the inguinal area of the subjects
DRUGPrevantics 3.15 % / 70 % Swabstick
Application of antiseptic drug to the inguinal area of the subjects
Sponsors
Professional Disposables International, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
Samples are blinded to the Microbiology group, participant, sponsor (1 of 2) and statistician
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Male or female at least 18 years of age and of any race 2. In good general health 3. Read, understand and sign the Informed Consent Form (ICF) 4. If female of child-bearing potential, are willing to use an acceptable method of contraception to prevent pregnancy (i.e. oral contraceptive, intra-uterine device, diaphragm, condom, abstinence, bilateral tubal ligation, or are in a monogamous relationship with a partner who has had a vasectomy) 5. Female subjects of child-bearing potential, must have a negative Urine Pregnancy Test (UPT) on Treatment Day prior to any applications of the study products
Exclusion criteria
1. Exposure of test sites to antimicrobial agents, medicated soaps, medicated shampoos, or medicated lotions, use of biocide-treated pools or hot tubs, use of tanning beds, or sunbathing during the 14-day washout conditioning period and during the test period 2. Exposure of the test sites to strong detergents, solvents, or other irritants during the 14-day washout conditioning period and during the test period 3. Wear fabric softener, bug repellent or UV-treated clothing during the 14-day washout conditioning period and during the test period 4. Receive an irritation score of 1 (any redness, swelling, rash, or dryness present at any treatment area) for any individual skin condition prior to the Treatment Day baseline sample collection 5. Use of systemic or topical antibiotic medications, steroid medications (other than for hormonal contraception or post-menopausal reasons), or any other product known to affect the normal microbial flora of the skin during the 14-day washout conditioning period and during the test period 6. Known allergies or sensitivities to vinyl, latex (rubber), alcohols, metals, inks, or tape adhesives, or to common antibacterial agents found in soaps, lotions, or ointments, particularly isopropyl alcohol or chlorhexidine gluconate 7. A medical diagnosis of a physical condition, such as a current or recent severe illness, asthma, diabetes, hepatitis, an organ transplant, mitral valve prolapses, congenital heart disease, internal prostheses, or any immunocompromised conditions such as AIDS (or HIV positive) 8. Pregnancy, plans to become pregnant within the washout and test periods of the study, or nursing a child 9. Any tattoos or scars within 2 (5.08 cm) of the test sites 10. Dermatoses, cuts, lesions, active skin rashes, or breaks or other skin disorders within 6 on or around the test sites 11. A currently active skin disease or inflammatory skin condition (for example, contact dermatitis) anywhere on the body that, in the opinion of the Consulting Physician or PI, would compromise subject safety or study integrity 12. Showering, bathing, or swimming within the 72-hour period prior to sampling for Treatment Day, and throughout the test period 13. Participation in another clinical study in the past 30 days or current participation in another clinical study at time of signing informed consent 14. Any medical condition or use of any medications that, in the opinion of the PI, should preclude participation 15. Unwillingness to fulfill the performance requirements of the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Bacterial Microflora in the Inguinal Area | 10 minutes | Bacterial microflora (log10) will be measured via cup scrub method following the administration of the intervention |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Bacterial Microflora in the Inguinal Area | 30 seconds | Bacterial microflora (log10) will be measured via cup scrub method following the administration of the intervention |
Countries
Romania
Participant flow
Pre-assignment details
328 individual subjects were consented, screened, treated and completed the study. Each subject is able to receive 2 test products (1 on each side of their body).
Participants by arm
| Arm | Count |
|---|---|
| Project X 26ml 3.15% w/v CHG/70% v/v IPA contained within a saturated at use applicator. 26ml volume. Single use.
Isopropyl alcohol & Chlorhexidine Gluconate Antiseptic: Application of antiseptic drug to the inguinal area of the subjects | 82 |
| Project X 10.5ml 3.15% w/v CHG/70% v/v IPA contained within a saturated at use applicator. 10.5ml volume. Single use.
Isopropyl alcohol & Chlorhexidine Gluconate Antiseptic: Application of antiseptic drug to the inguinal area of the subjects | 81 |
| Project X 5.1ml 3.15% w/v CHG/70% v/v IPA contained within a saturated at use applicator. 10.5ml volume. Single use.
Isopropyl alcohol & Chlorhexidine Gluconate Antiseptic: Application of antiseptic drug to the inguinal area of the subjects | 83 |
| Prevantics Maxi Swabstick 3.15% w/v CHG/70% v/v IPA contained within pre-saturated applicator. 5.1ml volume. Single use.
Prevantics 3.15 % / 70 % Swabstick: Application of antiseptic drug to the inguinal area of the subjects | 83 |
| Total | 329 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Withdrawal by Subject | 0 | 0 | 0 | 1 |
Baseline characteristics
| Characteristic | Total | Prevantics Maxi Swabstick | Project X 5.1ml | Project X 10.5ml | Project X 26ml |
|---|---|---|---|---|---|
| Age, Continuous | 54.67 years STANDARD_DEVIATION 10.63 | 55.06 years STANDARD_DEVIATION 10.23 | 54.48 years STANDARD_DEVIATION 10.99 | 54.39 years STANDARD_DEVIATION 11.7 | 54.76 years STANDARD_DEVIATION 9.54 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 329 Participants | 83 Participants | 83 Participants | 81 Participants | 82 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Height | 163.84 cm STANDARD_DEVIATION 7.63 | 164.15 cm STANDARD_DEVIATION 7.85 | 164.65 cm STANDARD_DEVIATION 8.13 | 163.54 cm STANDARD_DEVIATION 7.84 | 163.03 cm STANDARD_DEVIATION 6.56 |
| Race/Ethnicity, Customized American Indian/Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Black/African American | 2 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Other/Combination of 2 or more races (specify) | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Subject Refused to Disclose | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized White/Caucasian | 327 Participants | 82 Participants | 83 Participants | 81 Participants | 81 Participants |
| Region of Enrollment Romania | 329 participants | 83 participants | 83 participants | 81 participants | 82 participants |
| Sex: Female, Male Female | 294 Participants | 72 Participants | 71 Participants | 74 Participants | 77 Participants |
| Sex: Female, Male Male | 35 Participants | 11 Participants | 12 Participants | 7 Participants | 5 Participants |
| Weight | 74.47 kg STANDARD_DEVIATION 14.77 | 74.98 kg STANDARD_DEVIATION 15.06 | 75.04 kg STANDARD_DEVIATION 16.11 | 73.37 kg STANDARD_DEVIATION 13.84 | 74.49 kg STANDARD_DEVIATION 13.98 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 82 | 0 / 81 | 0 / 83 | 0 / 82 |
| other Total, other adverse events | 0 / 82 | 0 / 81 | 0 / 83 | 0 / 82 |
| serious Total, serious adverse events | 0 / 82 | 0 / 81 | 0 / 83 | 0 / 82 |
Outcome results
Primary
Change in Bacterial Microflora in the Inguinal Area
Bacterial microflora (log10) will be measured via cup scrub method following the administration of the intervention
Time frame: 10 minutes
Population: The Overall Number of Participants Analyzed represents the modified intent to treat (mITT) dataset where the Participant Flow represents the intent to treat (ITT) dataset. Additionally, each subject is able to receive 2 test products (1 on each side of their body).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Project X 26ml | Change in Bacterial Microflora in the Inguinal Area | -3.86 log10 CFU | Standard Deviation 1.58 |
| Project X 10.5ml | Change in Bacterial Microflora in the Inguinal Area | -4.34 log10 CFU | Standard Deviation 1.48 |
| Project X 5.1ml | Change in Bacterial Microflora in the Inguinal Area | -3.65 log10 CFU | Standard Deviation 1.36 |
| Prevantics Maxi Swabstick | Change in Bacterial Microflora in the Inguinal Area | -3.80 log10 CFU | Standard Deviation 1.42 |
Secondary
Change in Bacterial Microflora in the Inguinal Area
Bacterial microflora (log10) will be measured via cup scrub method following the administration of the intervention
Time frame: 30 seconds
Population: The Overall Number of Participants Analyzed represents the modified intent to treat (mITT) dataset where the Participant Flow represents the intent to treat (ITT) dataset. Additionally, each subject is able to receive 2 test products (1 on each side of their body).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Project X 26ml | Change in Bacterial Microflora in the Inguinal Area | -3.86 log10 CFU | Standard Deviation 1.55 |
| Project X 10.5ml | Change in Bacterial Microflora in the Inguinal Area | -3.76 log10 CFU | Standard Deviation 1.36 |
| Project X 5.1ml | Change in Bacterial Microflora in the Inguinal Area | -3.70 log10 CFU | Standard Deviation 1.58 |
| Prevantics Maxi Swabstick | Change in Bacterial Microflora in the Inguinal Area | -3.76 log10 CFU | Standard Deviation 1.48 |