Surgical Site InfectionPhase 3NCT04218110
Preoperative Skin Preparation Study to Evaluate the Antimicrobial Capabilities of Four Test Substances
A Phase 3 study testing Isopropyl alcohol & Chlorhexidine Gluconate Antiseptic and Prevantics 3.15 % / 70 % Swabstick in people with Surgical Site Infection, run by Professional Disposables International, Inc. at 1 site in Romania.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Surgical Site Infection
- What is being tested?
- Isopropyl alcohol & Chlorhexidine Gluconate Antiseptic and Prevantics 3.15 % / 70 % Swabstick
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 329 participants
- Where
- 1 siteRomania
- Study dates
- 11 Feb 2020to 31 Mar 2020
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female at least 18 years of age and of any race
- In good general health
- Read, understand and sign the Informed Consent Form (ICF)
- 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)
- 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
Who cannot join
- 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
- Exposure of the test sites to strong detergents, solvents, or other irritants during the 14-day washout conditioning period and during the test period
- Wear fabric softener, bug repellent or UV-treated clothing during the 14-day washout conditioning period and during the test period
- 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
- 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
- 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
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- 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)
- Pregnancy, plans to become pregnant within the washout and test periods of the study, or nursing a child
- Any tattoos or scars within 2" (5.08 cm) of the test sites
- Dermatoses, cuts, lesions, active skin rashes, or breaks or other skin disorders within 6" on or around the test sites
- 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
- Showering, bathing, or swimming within the 72-hour period prior to sampling for Treatment Day, and throughout the test period
- Participation in another clinical study in the past 30 days or current participation in another clinical study at time of signing informed consent
- Any medical condition or use of any medications that, in the opinion of the PI, should preclude participation
- Unwillingness to fulfill the performance requirements of the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Preoperative Skin Preparation Study Following ASTM E1173 Methods to Evaluate the Antimicrobial Capabilities of Four Test Substances
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.
- Conditions
- Surgical Site Infection
- Being tested
- Isopropyl alcohol & Chlorhexidine Gluconate Antiseptic, Prevantics 3.15 % / 70 % Swabstick
- Keywords
- Preventative
- Medical subject headings
- Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Isopropyl alcohol & Chlorhexidine Gluconate AntisepticDrug
Also called Project X 26ml
Application of antiseptic drug to the inguinal area of the subjects
Isopropyl alcohol & Chlorhexidine Gluconate AntisepticDrug
Also called Project X 10.5ml
Application of antiseptic drug to the inguinal area of the subjects
Isopropyl alcohol & Chlorhexidine Gluconate AntisepticDrug
Also called Project X 5.1ml
Application of antiseptic drug to the inguinal area of the subjects
Prevantics 3.15 % / 70 % SwabstickDrug
Also called Prevantics Maxi Swabstick
Application of antiseptic drug to the inguinal area of the subjects
| Study group | Role | What they receive |
|---|---|---|
| Project X 26ml | Experimental | 3.15% w/v CHG (chlorhexidine gluconate) /70% v/v IPA (isopropyl alcohol) contained within a saturated at use applicator. 26ml volume. Single use. Receives: Drug: Isopropyl alcohol & Chlorhexidine Gluconate Antiseptic |
| Project X 10.5ml | Experimental | 3.15% w/v CHG (chlorhexidine gluconate) /70% v/v IPA (isopropyl alcohol) contained within a saturated at use applicator. 10.5ml volume. Single use. Receives: Drug: Isopropyl alcohol & Chlorhexidine Gluconate Antiseptic |
| Project X 5.1ml | Experimental | 3.15% w/v CHG (chlorhexidine gluconate) /70% v/v IPA (isopropyl alcohol) contained within a saturated at use applicator. 10.5ml volume. Single use. Receives: Drug: Isopropyl alcohol & Chlorhexidine Gluconate Antiseptic |
| Prevantics Maxi Swabstick | Active comparator | 3.15% w/v CHG (chlorhexidine gluconate) /70% v/v IPA (isopropyl alcohol) contained within pre-saturated applicator. 5.1ml volume. Single use. Receives: Drug: Prevantics 3.15 % / 70 % Swabstick |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Bacterial Microflora in the Inguinal Area
Bacterial microflora (log10) will be measured via cup scrub method following the administration of the intervention
Measured: 10 minutes
Secondary outcomes (1)
Change in Bacterial Microflora in the Inguinal Area
Bacterial microflora (log10) will be measured via cup scrub method following the administration of the intervention
Measured: 30 seconds
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2020
- Study start11 Feb 2020
- Primary completion10 Mar 2020
- Study completion31 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Surgical Site InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 329 participants (actual)
Sponsor and investigators
- Lead sponsor
- Professional Disposables International, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rozalia Olsavszky, MD, Principal investigator, EUROFINS EVIC PRODUCT TESTING ROMANIA S.R.L
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04218110
- Sponsor's protocol ID
- ER19/232
- Status last verified
- Oct 2021
- First submitted
- 30 Dec 2019
- Last updated
- 22 Oct 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Skin Preparation Study Following ASTM E1173 Methods to Evaluate the Antimicrobial Capabilities of Four Test Substances
- ClinicalTrials.gov ID
- NCT04218110
- Acronym / sponsor ID
- ER19/232
- Conditions
- Surgical Site Infection
- Keywords
- Preventative
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 329 participants (actual)
- Lead sponsor
- Professional Disposables International, Inc.Industry (pharma, biotech, devices)
- Study start
- 11 Feb 2020 (actual)
- Primary completion
- 10 Mar 2020 (actual)
- Study completion
- 31 Mar 2020 (actual)
- First posted
- 6 Jan 2020 (actual)
- Results
- Posted 22 Oct 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Project X 26ml | Experimental | Drug: Isopropyl alcohol & Chlorhexidine Gluconate Antiseptic3.15% w/v CHG (chlorhexidine gluconate) /70% v/v IPA (isopropyl alcohol) contained within a saturated at use applicator. 26ml volume. Single use. |
| Project X 10.5ml | Experimental | Drug: Isopropyl alcohol & Chlorhexidine Gluconate Antiseptic3.15% w/v CHG (chlorhexidine gluconate) /70% v/v IPA (isopropyl alcohol) contained within a saturated at use applicator. 10.5ml volume. Single use. |
| Project X 5.1ml | Experimental | Drug: Isopropyl alcohol & Chlorhexidine Gluconate Antiseptic3.15% w/v CHG (chlorhexidine gluconate) /70% v/v IPA (isopropyl alcohol) contained within a saturated at use applicator. 10.5ml volume. Single use. |
| Prevantics Maxi Swabstick | Active comparator | Drug: Prevantics 3.15 % / 70 % Swabstick3.15% w/v CHG (chlorhexidine gluconate) /70% v/v IPA (isopropyl alcohol) contained within pre-saturated applicator. 5.1ml volume. Single use. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female at least 18 years of age and of any race
- In good general health
- Read, understand and sign the Informed Consent Form (ICF)
- 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)
- 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
Key exclusion criteria (15 listed)
- 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
- Exposure of the test sites to strong detergents, solvents, or other irritants during the 14-day washout conditioning period and during the test period
- Wear fabric softener, bug repellent or UV-treated clothing during the 14-day washout conditioning period and during the test period
- 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
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Isopropyl alcohol & Chlorhexidine Gluconate AntisepticAlso: Project X 26mlApplication of antiseptic drug to the inguinal area of the subjects | Drug | Project X 26ml |
| Isopropyl alcohol & Chlorhexidine Gluconate AntisepticAlso: Project X 10.5mlApplication of antiseptic drug to the inguinal area of the subjects | Drug | Project X 10.5ml |
| Isopropyl alcohol & Chlorhexidine Gluconate AntisepticAlso: Project X 5.1mlApplication of antiseptic drug to the inguinal area of the subjects | Drug | Project X 5.1ml |
| Prevantics 3.15 % / 70 % SwabstickAlso: Prevantics Maxi SwabstickApplication of antiseptic drug to the inguinal area of the subjects | Drug | Prevantics Maxi Swabstick |
Primary outcome
Change in Bacterial Microflora in the Inguinal Area
Time frame: 10 minutes
Bacterial microflora (log10) will be measured via cup scrub method following the administration of the intervention
1 secondary outcome
Change in Bacterial Microflora in the Inguinal Area
Time frame: 30 seconds
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rozalia Olsavszky, MD principal investigator
EUROFINS EVIC PRODUCT TESTING ROMANIA S.R.L
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Isopropyl alcohol & Chlorhexidine Gluconate Antiseptic and Prevantics 3.15 % / 70 % Swabstick in people with Surgical Site Infection, run by Professional Disposables International, Inc. at 1 site in Romania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Romania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Oct 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Bacterial Microflora in the Inguinal Area (time frame: 10 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2021.