Skin Flora Bacterial Reduction Post-product ApplicationPhase 3NCT01968356
In-vivo Efficacy Study of Patient Preoperative Preps
A Phase 3 study testing 3M CHG/IPA Prep Colorless, 3M CHG/IPA Prep Tint and ChloraPrep in people with Skin Flora Bacterial Reduction Post-product Application, run by Solventum US LLC at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the antimicrobial efficacy of the 3M CHG/IPA Prep on skin flora of the abdominal and 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
- Skin Flora Bacterial Reduction Post-product Application
- What is being tested?
- 3M CHG/IPA Prep Colorless, 3M CHG/IPA Prep Tint and ChloraPrep
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 171 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2013to Jan 2014
- 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 general health
- Minimum skin flora baseline requirements on abdomen and groin
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 areas
- 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
BioScience Laboratories, Inc.
Bozeman, Montana, 59718
About this study
Official title: Assessment of the Antimicrobial Efficacy of 3M CHG/IPA Preoperative Skin Preparation Against Resident Human Skin Flora on the Abdominal and Inguinal Regions
The purpose of this study is to evaluate the antimicrobial efficacy of the 3M CHG/IPA Prep on skin flora of the abdominal and inguinal regions of human subjects.
Read the detailed description
The primary efficacy is evaluated by demonstration that the product provides a lower bound of the 95% confidence interval of percent responders that is greater than or equal to 70%. On the abdominal sites, a responder is defined as a subject with a 2-log10 per cm2 bacterial reduction at 10 minutes and for whom the skin flora does not return to baseline at 6 hours. On the inguinal sites, a responder is defined as a subject with a 3-log10 per cm2 bacterial reduction at 10 minutes and for whom the skin flora does not return to baseline at 6 hours.
- Being tested
- 3M CHG/IPA Prep Colorless, 3M CHG/IPA Prep Tint, ChloraPrep, Saline
- 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 Prep ColorlessDrug
Also called Chlorhexidine glucontate and Isopropyl alcohol, CHG 2% / IPA 70%, Chlorhexidine gluconate 2% / Isopropyl alcohol 70%
Apply topically.
3M CHG/IPA Prep TintDrug
Also called Chlorhexidine glucontate and Isopropyl alcohol, CHG 2%/IPA 70%, Chlorhexidine gluconate 2% / Isopropyl alcohol 70%
Apply topically.
ChloraPrepDrug
Also called ChloraPrep One-Step, ChloraPrep Patient Preoperative Skin Preparation, 2% CHG/70% IPA, Chlorhexidine glucontate and Isopropyl alcohol
Apply topically.
SalineDrug
Also called 0.9% NaCl, Normal Saline
Apply topically.
| Study group | Role | What they receive |
|---|---|---|
| 3M CHG/IPA Prep Colorless | Experimental | Applied topically for 30 seconds to the abdominal region or 2 minutes to the inguinal region, and allow to dry for 3 minutes. Receives: Drug: 3M CHG/IPA Prep Colorless |
| 3M CHG/IPA Prep Tint | Experimental | Applied topically for 30 seconds to the abdominal region or 2 minutes to the inguinal region, and allow to dry for 3 minutes. Receives: Drug: 3M CHG/IPA Prep Tint |
| ChloraPrep Hi-Lite Orange | Active comparator | Applied topically for 30 seconds to the abdominal region or 2 minutes to the inguinal region, and allow to dry for 3 minutes. Receives: Drug: ChloraPrep |
| Normal Saline | Placebo comparator | Applied topically for 30 seconds to the abdominal region or 2 minutes to the inguinal region, and allow to dry for 3 minutes. Receives: Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Responder Rate
On the abdominal region a responder was a subject with a 2-log10/cm2 bacterial reduction at 10 minutes and for whom the skin flora did not return to baseline at 6 hours.
On the inguinal region a responder was a subject with a 3-log10/cm2 bacterial reduction at 10 minutes and for whom the skin flora did not return to baseline at 6 hours.
Measured: baseline, 10 minute post-product application and 6 hour post-product application
Skin Flora Baseline for Abdominal and Inguinal Regions
Log10/cm2 baseline skin flora for abdominal and inguinal regions
Measured: Baseline
Skin Flora Recovery Post-treatment
Log10/cm2 recovery of skin flora at 10 minutes and 6 hours following application of study treatments for abdominal and inguinal regions
Measured: 10 minutes and 6 hours post-treatment
Reduction of Skin Flora Post-treatment
Log10/cm2 reduction of skin flora, relative to Treatment Day baseline log10/cm2, at 10 minutes and 6 hours
Measured: Baseline, 10 minutes and 6 hours
Secondary outcomes (3)
Safety as Assessed by Skin Irritation Scores
Skin irritation rating (0-3) scores for dryness, edema, erythema and rash. 0 = no reaction, 1 = mild, 2 = moderate, 3 = severe. A skin irritation rating of 3 in any category represents significant irritation and qualifies as an adverse event.
Measured: Baseline
Safety as Assessed by Skin Irritation Scores
Skin irritation rating (0-3) scores for dryness, edema, erythema and rash. 0 = no reaction, 1 = mild, 2 = moderate, 3 = severe. A skin irritation rating of 3 in any category represents significant irritation and qualifies as an adverse event.
Measured: 10 minutes post-treatment
Safety as Assessed by Skin Irritation Scores
Skin irritation rating (0-3) scores for dryness, edema, erythema and rash. 0 = no reaction, 1 = mild, 2 = moderate, 3 = severe. A skin irritation rating of 3 in any category represents significant irritation and qualifies as an adverse event.
Measured: 6 hours post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2013 (estimated)
- Study startOct 2013
- Primary completionJan 2014
- Study completionJan 2014
Why it stopped: Study discontinued due to data quality issues.
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 Skin Flora Bacterial Reduction Post-product ApplicationStudies 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
- 171 participants (actual)
Sponsor and investigators
- Lead sponsor
- Solventum US LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- 3M
- Responsible party
- Sponsor
- Investigators
- Robert R McCormack, BS, Principal investigator, BioScience Laboratories, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01968356
- Sponsor's protocol ID
- EM-012759
- Status last verified
- Sep 2024
- First submitted
- 21 Oct 2013
- Last updated
- 2 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
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
- Assessment of the Antimicrobial Efficacy of 3M CHG/IPA Preoperative Skin Preparation Against Resident Human Skin Flora on the Abdominal and Inguinal Regions
- ClinicalTrials.gov ID
- NCT01968356
- Acronym / sponsor ID
- EM-012759
- Keywords
- surgical skin prep, CHG, IPA
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study discontinued due to data quality issues.
- Enrolment
- 171 participants (actual)
- Lead sponsor
- Solventum US LLCIndustry (pharma, biotech, devices)
- Collaborators
- 3M
- Study start
- Oct 2013
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 24 Oct 2013 (estimated)
- Results
- Posted 3 Aug 2021
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 evaluate the antimicrobial efficacy of the 3M CHG/IPA Prep on skin flora of the abdominal and inguinal regions of human subjects.
Detailed description
The primary efficacy is evaluated by demonstration that the product provides a lower bound of the 95% confidence interval of percent responders that is greater than or equal to 70%. On the abdominal sites, a responder is defined as a subject with a 2-log10 per cm2 bacterial reduction at 10 minutes and for whom the skin flora does not return to baseline at 6 hours. On the inguinal sites, a responder is defined as a subject with a 3-log10 per cm2 bacterial reduction at 10 minutes and for whom the skin flora does not return to baseline at 6 hours.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 3M CHG/IPA Prep Colorless | Experimental | Drug: 3M CHG/IPA Prep ColorlessApplied topically for 30 seconds to the abdominal region or 2 minutes to the inguinal region, and allow to dry for 3 minutes. |
| 3M CHG/IPA Prep Tint | Experimental | Drug: 3M CHG/IPA Prep TintApplied topically for 30 seconds to the abdominal region or 2 minutes to the inguinal region, and allow to dry for 3 minutes. |
| ChloraPrep Hi-Lite Orange | Active comparator | Drug: ChloraPrepApplied topically for 30 seconds to the abdominal region or 2 minutes to the inguinal region, and allow to dry for 3 minutes. |
| Normal Saline | Placebo comparator | Drug: SalineApplied topically for 30 seconds to the abdominal region or 2 minutes to the inguinal region, and allow to dry for 3 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 general health
- Minimum skin flora baseline requirements on abdomen and groin
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 areas
- 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 |
|---|---|---|
| 3M CHG/IPA Prep ColorlessAlso: Chlorhexidine glucontate and Isopropyl alcohol, CHG 2% / IPA 70%, Chlorhexidine gluconate 2% / Isopropyl alcohol 70%Apply topically. | Drug | 3M CHG/IPA Prep Colorless |
| 3M CHG/IPA Prep TintAlso: Chlorhexidine glucontate and Isopropyl alcohol, CHG 2%/IPA 70%, Chlorhexidine gluconate 2% / Isopropyl alcohol 70%Apply topically. | Drug | 3M CHG/IPA Prep Tint |
| ChloraPrepAlso: ChloraPrep One-Step, ChloraPrep Patient Preoperative Skin Preparation, 2% CHG/70% IPA, Chlorhexidine glucontate and Isopropyl alcoholApply topically. | Drug | ChloraPrep Hi-Lite Orange |
| SalineAlso: 0.9% NaCl, Normal SalineApply topically. | Drug | Normal Saline |
Primary outcome
Responder Rate
Time frame: baseline, 10 minute post-product application and 6 hour post-product application
On the abdominal region a responder was a subject with a 2-log10/cm2 bacterial reduction at 10 minutes and for whom the skin flora did not return to baseline at 6 hours. On the inguinal region a responder was a subject with a 3-log10/cm2 bacterial reduction at 10 minutes and for whom the skin flora did not return to baseline at 6 hours.
Skin Flora Baseline for Abdominal and Inguinal Regions
Time frame: Baseline
Log10/cm2 baseline skin flora for abdominal and inguinal regions
Skin Flora Recovery Post-treatment
Time frame: 10 minutes and 6 hours post-treatment
Log10/cm2 recovery of skin flora at 10 minutes and 6 hours following application of study treatments for abdominal and inguinal regions
Reduction of Skin Flora Post-treatment
Time frame: Baseline, 10 minutes and 6 hours
Log10/cm2 reduction of skin flora, relative to Treatment Day baseline log10/cm2, at 10 minutes and 6 hours
3 secondary outcomes
Safety as Assessed by Skin Irritation Scores
Time frame: Baseline
Safety as Assessed by Skin Irritation Scores
Time frame: 10 minutes post-treatment
Safety as Assessed by Skin Irritation Scores
Time frame: 6 hours post-treatment
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.
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.
Robert R McCormack, BS principal investigator
BioScience Laboratories, Inc.
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 3M CHG/IPA Prep Colorless, 3M CHG/IPA Prep Tint and ChloraPrep in people with Skin Flora Bacterial Reduction Post-product Application, 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: stopped early, 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 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 3 Aug 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?
Responder Rate (time frame: baseline, 10 minute post-product application and 6 hour post-product application). The study lists 4 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 2 Oct 2024.