Surgical Skin PreparationPhase 2NCT03681990
In Vivo Preoperative Skin Preparation Efficacy Study Within a Defined Product Coverage Area
A Phase 2 study testing 3M CHG/IPA Prep in people with Surgical Skin Preparation and Surgical Procedure, Unspecified, run by Solventum US LLC at 1 site in Romania.
Trial summary
This study evaluates reduction of resident flora produced by the test product within a defined prepped area of skin. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Surgical Skin Preparation, Surgical Procedure, Unspecified
- What is being tested?
- 3M CHG/IPA Prep
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteRomania
- Study dates
- 6 Jun 2017to 4 Jul 2017
- Phase
- Phase 2
- 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
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male subjects of any race who are at least 18 years of age,
- Subjects must have an area on their back region to accommodate the treatment coverage area,
- Subjects must be in good general health,
- Subjects who satisfy all inclusion/exclusion criteria and will voluntarily read and sign the Informed Consent Form,
- Subjects who have good skin condition on the test sites,
- Subjects who are willing to report to the study facility approximately 72 hours prior to Screening or Treatment Day for clipping, if needed,
- Subjects who are willing to avoid showering and tub-bathing within 72 hours prior to Screening and Treatment Days, and
- Subjects who have Screening Day baseline counts of > 3.00 log10 per cm2 in each of the 3 sample sites (center, mid-peripheral and peripheral) in the treatment area (back region).
Who cannot join
- Participation in another clinical study in the past 30 days, current participation in another clinical study, or previous participation in this study,
- Has taken antihistamines in the 48 hours prior to Treatment Day,
- Any tattoos, scars, breaks in the skin, or any form of dermatitis, or other skin disorders (including acne) on the applicable test areas,
- A history of skin allergies,
- A history of skin cancer within 6 inches of the test areas,
- Known sensitivity to acrylate-, chlorhexidine gluconate-, or alcohol-containing products, or to medical tape, metals, natural rubber latex, vinyl, or skin-marking inks,
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- A medical diagnosis with physical condition that may put the subject at risk, such as a current or recent severe illness, hepatitis, organ transplant, congestive heart disease, or any immunocompromised conditions, such as AIDS (or HIV positive),
- Any medical condition or use of any medications that, in the opinion of the Investigator, should preclude participation,
- Topical antimicrobial exposure within 14 days prior to Screening Day and throughout the study. Restrictions include, but are not limited to antimicrobial soaps, medicated shampoos, medicated lotions, antiperspirants/deodorants, perfumes, after shaves, and colognes,
- Use of systemic or topical antibiotic medications, steroid medications, or any other product known to affect the normal microbial flora of the skin within 14 days prior to Screening Day and throughout the study,
- Exposure of the test areas to solvents, acids, bases, strong detergents, fabric softener-treated clothing, or other household chemicals within 14 days prior to Screening Day and throughout the study,
- Swimming in chemically treated pools or bathing in hot tubs, spas, or whirlpools within 14 days prior to Screening Day and throughout the study,
- Use of tanning beds, hot waxes, or depilatories (in the applicable test areas) within 14 days prior to Screening Day and throughout the study
- Bathing and showering within 72 hours prior to Screening Day and throughout the study, or
- Subject has used moisturizers or any topical treatment (e.g. lotion, sunscreen or shaving cream) on the test sites in the 24-hour period prior to Screening Day and Treatment Day participation in the study.
Trial locations and contacts
1 site in 1 country.
Romania1 site
Eurofins Evic Romania/S.C. BIO HIGH TECH S.R.L.
Bucharest, 040256
About this study
Official title: Evaluation of Microbial Population Reductions Within a Defined Product Coverage Area
This study evaluates reduction of resident flora produced by the test product within a defined prepped area of skin.
Read the detailed description
Three different sample sites within a defined prepped area of skin were collected to determine whether reductions in resident flora produced by the test product are consistent.
- Being tested
- 3M CHG/IPA Prep
- Keywords
- surgical skin prep, CHG, IPA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3M CHG/IPA PrepDrug
Also called CHG 2%/IPA 70%, Chlorhexidine gluconate 2% / Isopropyl alcohol 70%, Chlorhexidine gluconate and Isopropyl alcohol
Apply topically to intact skin
| Study group | Role | What they receive |
|---|---|---|
| 3M CHG/IPA Prep / Center | Experimental | Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70% solution applied topically to intact skin; sample collected from center test site on skin in application area. Receives: Drug: 3M CHG/IPA Prep |
| 3M CHG/IPA Prep / Mid-peripheral | Experimental | Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70% solution applied topically to intact skin; sample collected from mid-peripheral test site on skin in application area. Receives: Drug: 3M CHG/IPA Prep |
| 3M CHG/IPA Prep / Peripheral | Experimental | Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70% solution applied topically to intact skin; sample collected from peripheral test site on skin in application area. Receives: Drug: 3M CHG/IPA Prep |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of Log Change of Skin Flora Relative to Pre-treatment (Baseline) in Each of 3 Sampling Sites at a Defined Post-treatment Sampling Time.
The primary measure of efficacy is change in skin flora log10 CFU/cm^2 in each of the skin sampling sites relative to baseline skin flora log10 CFU/cm^2. Baseline samples must satisfy the greater than or equal to 3.0 in each of the sampling sites, to be used for data analysis.
Measured: Post-treatment sampling randomized as 10-minute or 13-minute post-product application
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2018
- Study start6 Jun 2017
- Primary completion4 Jul 2017
- Study completion4 Jul 2017
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 Skin PreparationStudies 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Solventum US LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- 3M
- Responsible party
- Sponsor
- Investigators
- Rozalia Olsavszky, MD, Principal investigator, Eurofins/Evic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03681990
- Sponsor's protocol ID
- EM-012926
- Status last verified
- Sep 2024
- First submitted
- 31 Jul 2017
- Last updated
- 2 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Microbial Population Reductions Within a Defined Product Coverage Area
- ClinicalTrials.gov ID
- NCT03681990
- Acronym / sponsor ID
- EM-012926
- Keywords
- surgical skin prep, CHG, IPA
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Solventum US LLCIndustry (pharma, biotech, devices)
- Collaborators
- 3M
- Study start
- 6 Jun 2017 (actual)
- Primary completion
- 4 Jul 2017 (actual)
- Study completion
- 4 Jul 2017 (actual)
- First posted
- 24 Sep 2018 (actual)
- Results
- Posted 27 Jun 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates reduction of resident flora produced by the test product within a defined prepped area of skin.
Detailed description
Three different sample sites within a defined prepped area of skin were collected to determine whether reductions in resident flora produced by the test product are consistent.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 3M CHG/IPA Prep / Center | Experimental | Drug: 3M CHG/IPA PrepChlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70% solution applied topically to intact skin; sample collected from center test site on skin in application area. |
| 3M CHG/IPA Prep / Mid-peripheral | Experimental | Drug: 3M CHG/IPA PrepChlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70% solution applied topically to intact skin; sample collected from mid-peripheral test site on skin in application area. |
| 3M CHG/IPA Prep / Peripheral | Experimental | Drug: 3M CHG/IPA PrepChlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70% solution applied topically to intact skin; sample collected from peripheral test site on skin in application area. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male subjects of any race who are at least 18 years of age,
- Subjects must have an area on their back region to accommodate the treatment coverage area,
- Subjects must be in good general health,
- Subjects who satisfy all inclusion/exclusion criteria and will voluntarily read and sign the Informed Consent Form,
- Subjects who have good skin condition on the test sites,
Key exclusion criteria (15 listed)
- Participation in another clinical study in the past 30 days, current participation in another clinical study, or previous participation in this study,
- Has taken antihistamines in the 48 hours prior to Treatment Day,
- Any tattoos, scars, breaks in the skin, or any form of dermatitis, or other skin disorders (including acne) on the applicable test areas,
- A history of skin allergies,
- A history of skin cancer within 6 inches of the test areas,
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 |
|---|---|---|
| 3M CHG/IPA PrepAlso: CHG 2%/IPA 70%, Chlorhexidine gluconate 2% / Isopropyl alcohol 70%, Chlorhexidine gluconate and Isopropyl alcoholApply topically to intact skin | Drug | 3M CHG/IPA Prep / Center, 3M CHG/IPA Prep / Mid-peripheral, 3M CHG/IPA Prep / Peripheral |
Primary outcome
Comparison of Log Change of Skin Flora Relative to Pre-treatment (Baseline) in Each of 3 Sampling Sites at a Defined Post-treatment Sampling Time.
Time frame: Post-treatment sampling randomized as 10-minute or 13-minute post-product application
The primary measure of efficacy is change in skin flora log10 CFU/cm^2 in each of the skin sampling sites relative to baseline skin flora log10 CFU/cm^2. Baseline samples must satisfy the greater than or equal to 3.0 in each of the sampling sites, to be used for data analysis.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 3M CHG/IPA Prep in people with Surgical Skin Preparation and Surgical Procedure, Unspecified, run by Solventum US LLC 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 8 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 2 Oct 2024. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 27 Jun 2023). 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?
Comparison of Log Change of Skin Flora Relative to Pre-treatment (Baseline) in Each of 3 Sampling Sites at a Defined Post-treatment Sampling Time. (time frame: Post-treatment sampling randomized as 10-minute or 13-minute post-product application). 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 2 Oct 2024.