Surgical Skin PreparationPhase 3NCT04756154
Efficacy Study of Patient Preoperative Preps In-vivo
A Phase 3 study testing CHG/IPA Surgical skin preparation and Normal saline in people with Surgical Skin Preparation, run by Solventum US LLC at 1 site in United States.
Trial summary
The purpose of this study is to determine the antimicrobial efficacy of an investigational CHG/IPA prep on skin flora of the inguinal regions of human subjects. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Surgical Skin Preparation
- What is being tested?
- CHG/IPA Surgical skin preparation and Normal saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 154 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jul 2020to 28 Apr 2021
- 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
- Subjects of any race
- Subjects in good health
- Minimum skin flora baseline requirements on inguinal region
Who cannot join
- Any tattoos, scars, breaks in the skin, or any form of dermatitis, or other skin disorders (including acne) on the applicable test area
- Topical antimicrobial exposure within 14 days prior to screening and treatment days
- Use of systemic or topical antibiotics, steroid medications, or any other products known to affect the normal microbial flora of the skin within 14 days prior to screening and treatment days
Trial locations and contacts
1 site in 1 country.
United States1 site
Microbac Laboratories, Inc
Sterling, Virginia, 20164
About this study
Official title: Assessment of the Antimicrobial Efficacy of 3M™ SoluPrep™ Preoperative Skin Preparation Against Resident Human Skin Flora on the Inguinal Region
The purpose of this study is to determine the antimicrobial efficacy of an investigational CHG/IPA prep on skin flora of the inguinal regions of human subjects.
Read the detailed description
Non-inferiority of the investigational product to the FDA-approved active control for log10/cm2 recovery of skin flora relative to Treatment Day baseline log10/cm2 on the inguinal region at 10 minutes following application. Non-inferiority is based on a non-inferiority margin of 0.5 log10/cm2.
Superiority of the active products to the negative control for log10/cm2 recovery of skin flora relative to Treatment Day baseline log10/cm2 on the inguinal region at 10 minutes following application. A superiority margin of 1.2 log10/cm2 is used.
Number of observations for which the log10/cm2 recovery of skin flora on the inguinal region at 6 hours following application of the study products is higher than treatment day log10/cm2 baseline skin flora.
- Conditions
- Surgical Skin Preparation
- Being tested
- CHG/IPA Surgical skin preparation, Normal saline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CHG/IPA Surgical skin preparationDrug
Also called 2% CHG/70% IPA
Apply topically to the inguinal region for 2 minutes
Normal salineDrug
Also called 0.9% sodium chloride
Apply topically to the inguinal region for 2 minutes
| Study group | Role | What they receive |
|---|---|---|
| CHG/IPA Surgical skin preparation | Experimental | Apply topically to the inguinal region for 2 minutes Receives: Drug: CHG/IPA Surgical skin preparation |
| CHG/IPA Film-Forming Surgical skin preparation | Active comparator | Apply topically to the inguinal region for 2 minutes Receives: Drug: CHG/IPA Surgical skin preparation |
| Normal saline | Placebo comparator | Apply topically to the inguinal region for 2 minutes Receives: Drug: Normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Log Change (Reduction) in Skin Flora on the Inguinal Region at 10 Minutes
Immediate efficacy endpoint which is defined as the average treatment effect (ATE) log10 CFU/cm2 of skin flora on the inguinal region at 10 minutes following application of the study products relative to the treatment day baseline skin flora
Measured: 10 minutes
Log Change (Reduction) in Skin Flora on the Inguinal Region at 6 Hours
Persistent efficacy endpoint which is a binary endpoint with success/failure, where "success" is defined as log10 CFU/cm2 of skin flora on the inguinal region at 6 hours following application of the study products being lower than the treatment day baseline skin flora
Measured: 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2021
- Study start6 Jul 2020
- Primary completion28 Apr 2021
- Study completion28 Apr 2021
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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 154 participants (actual)
Sponsor and investigators
- Lead sponsor
- Solventum US LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- 3M
- Responsible party
- Sponsor
- Investigators
- Muhammad H Bashir, MD, CCRP, Principal investigator, Microbac
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04756154
- Sponsor's protocol ID
- EM-05-014624
- Status last verified
- Sep 2024
- First submitted
- 20 Jan 2021
- Last updated
- 1 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 1 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Antimicrobial Efficacy of 3M™ SoluPrep™ Preoperative Skin Preparation Against Resident Human Skin Flora on the Inguinal Region
- ClinicalTrials.gov ID
- NCT04756154
- Acronym / sponsor ID
- EM-05-014624
- Conditions
- Surgical Skin Preparation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 154 participants (actual)
- Lead sponsor
- Solventum US LLCIndustry (pharma, biotech, devices)
- Collaborators
- 3M
- Study start
- 6 Jul 2020 (actual)
- Primary completion
- 28 Apr 2021 (actual)
- Study completion
- 28 Apr 2021 (actual)
- First posted
- 16 Feb 2021 (actual)
- Results
- Posted 1 Aug 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the antimicrobial efficacy of an investigational CHG/IPA prep on skin flora of the inguinal regions of human subjects.
Detailed description
Non-inferiority of the investigational product to the FDA-approved active control for log10/cm2 recovery of skin flora relative to Treatment Day baseline log10/cm2 on the inguinal region at 10 minutes following application. Non-inferiority is based on a non-inferiority margin of 0.5 log10/cm2.
Superiority of the active products to the negative control for log10/cm2 recovery of skin flora relative to Treatment Day baseline log10/cm2 on the inguinal region at 10 minutes following application. A superiority margin of 1.2 log10/cm2 is used.
Number of observations for which the log10/cm2 recovery of skin flora on the inguinal region at 6 hours following application of the study products is higher than treatment day log10/cm2 baseline skin flora.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CHG/IPA Surgical skin preparation | Experimental | Drug: CHG/IPA Surgical skin preparationApply topically to the inguinal region for 2 minutes |
| CHG/IPA Film-Forming Surgical skin preparation | Active comparator | Drug: CHG/IPA Surgical skin preparationApply topically to the inguinal region for 2 minutes |
| Normal saline | Placebo comparator | Drug: Normal salineApply topically to the inguinal region for 2 minutes |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subjects of any race
- Subjects in good health
- Minimum skin flora baseline requirements on inguinal region
Key exclusion criteria (3 listed)
- Any tattoos, scars, breaks in the skin, or any form of dermatitis, or other skin disorders (including acne) on the applicable test area
- Topical antimicrobial exposure within 14 days prior to screening and treatment days
- Use of systemic or topical antibiotics, steroid medications, or any other products known to affect the normal microbial flora of the skin within 14 days prior to screening and treatment days
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 |
|---|---|---|
| CHG/IPA Surgical skin preparationAlso: 2% CHG/70% IPAApply topically to the inguinal region for 2 minutes | Drug | CHG/IPA Film-Forming Surgical skin preparation, CHG/IPA Surgical skin preparation |
| Normal salineAlso: 0.9% sodium chlorideApply topically to the inguinal region for 2 minutes | Drug | Normal saline |
Primary outcome
Log Change (Reduction) in Skin Flora on the Inguinal Region at 10 Minutes
Time frame: 10 minutes
Immediate efficacy endpoint which is defined as the average treatment effect (ATE) log10 CFU/cm2 of skin flora on the inguinal region at 10 minutes following application of the study products relative to the treatment day baseline skin flora
Log Change (Reduction) in Skin Flora on the Inguinal Region at 6 Hours
Time frame: 6 hours
Persistent efficacy endpoint which is a binary endpoint with success/failure, where "success" is defined as log10 CFU/cm2 of skin flora on the inguinal region at 6 hours following application of the study products being lower than the treatment day baseline skin flora
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Surgical Skin Preparation
Enrolling by invitationObservational study
Harvesting Cells for Experimental Cancer Treatments
Melanoma, Gastrointestinal Cancer
RecruitingPhase 4
Skin Preparation for Elective Foot and Ankle Surgery
Microbial Colonization, Foot and Ankle Disorders
RecruitingPhase 3
Optimization of Skin Preparation to Reduce Cutibacterium Acnes Colonization in Superficial and Deep Samples During Prosthetic Shoulder Surgery in Male Patients
Cutibacterium Acnes Infection
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.
Muhammad H Bashir, MD, CCRP principal investigator
Microbac
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 CHG/IPA Surgical skin preparation and Normal saline in people with Surgical Skin Preparation, run by Solventum US LLC at 1 site in United States.
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 3 inclusion and 3 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 1 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 United States. 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. Some participants in this study may receive a placebo. 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 1 Aug 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?
Log Change (Reduction) in Skin Flora on the Inguinal Region at 10 Minutes (time frame: 10 minutes). The study lists 2 primary outcomes in all. 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 1 Oct 2024.