Bacterial Reduction on Skin Flora Post-product ApplicationPhase 3NCT01968707
In-vivo Efficacy Study of Patient Pre-operative Preps
A Phase 3 study testing ChloraPrep Hi-Lite Orange, Normal saline and 3M CHG/IPA Prep Tint 10.5-mL in people with Bacterial Reduction on Skin Flora Post-product Application, 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 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
- Bacterial Reduction on Skin Flora Post-product Application
- What is being tested?
- ChloraPrep Hi-Lite Orange, Normal saline and 3M CHG/IPA Prep Tint 10.5-mL
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 426 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2013to Jun 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.
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 determine 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
- ChloraPrep Hi-Lite Orange, Normal saline, 3M CHG/IPA Prep Tint 10.5-mL, 3M CHG/IPA Prep Tint 26-mL
- Keywords
- surgical prep, CHG, IPA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChloraPrep Hi-Lite OrangeDrug
Also called ChloraPrep One-Step, Chlorhexidine gluconate 2% / Isopropyl alcohol 70%, Chlorhexidine gluconate 2% w/v / Isopropyl alcohol 70% v/v, 2% CHG / 70% IPA
Apply topically.
Normal salineDrug
Also called 0.9% Sodium Chloride, Sterile Saline, 0.9% NaCl, Saline
Apply topically.
3M CHG/IPA Prep Tint 10.5-mLDrug
Also called Chlorhexidine Gluconate and Isopropyl Alcohol, Chlorhexidine gluconate 2% / Isopropyl alcohol 70%, Chlorhexidine gluconate 2% w/v / Isopropyl alcohol 70% v/v, 2% CHG / 70% IPA
Apply topically.
3M CHG/IPA Prep Tint 26-mLDrug
Also called Chlorhexidine Gluconate and Isopropyl Alcohol, Chlorhexidine gluconate 2% / Isopropyl alcohol 70%, Chlorhexidine gluconate 2% w/v / Isopropyl alcohol 70% v/v, 2% CHG / 70% IPA
Apply topically
| Study group | Role | What they receive |
|---|---|---|
| ChloraPrep Hi-Lite Orange | Active comparator | Apply 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 Hi-Lite Orange |
| Normal Saline | Placebo comparator | Apply topically for 30 seconds to the abdominal region or 2 minutes to the inguinal region, and allow to dry for 3 minutes. Receives: Drug: Normal saline |
| 3M CHG/IPA Prep Tint 10.5 mL | Experimental | Apply 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 10.5-mL |
| 3M CHG/IPA Prep Tint 26-mL | Experimental | Apply 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 26-mL |
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.
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.
Measured: baseline, 10 minutes post-product application and 6 hour post-product application
Secondary outcomes (6)
Reduction of Skin Flora 6 Hours Post-treatment
log10/cm2 reduction of skin flora, relative to treatment day baseline (log10/cm2), at 6 hours post-treatment
Measured: 6 hours
Reduction of Skin Flora 10 Minutes Post-treatment
log10/cm2 reduction of skin flora, relative to treatment day baseline (log10/cm2), at 10 minutes post-treatment
Measured: 10 minutes
Skin Flora Recovery 6-hours Post-treatment
Log10/cm2 recovery of skin flora at 6 hours following application of study treatment
Measured: 6 hours post-treatment
Skin Flora Recovery 10 Minutes Post-treatment
Log10/cm2 recovery of skin flora at 10 minutes following application of study treatments
Measured: 10 minutes post-treatment
Skin Flora Baseline for the Abdominal and Inguinal Region.
Log10/cm2 baseline skin flora for abdominal and inguinal regions
Measured: Baseline
Safety as Assessed by Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score
Skin irritation (dryness, edema, erythema, rash) assessed on the test sites using a 0-3 rating scale: 0=no reaction, 1=mild, 2=moderated, 3=severe
Measured: Assessed at baseline (pre-treatment) and 10 minute post-treatment and 6 hour 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 completionJun 2014
- Study completionJun 2014
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 Bacterial Reduction on Skin Flora 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
- 426 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, MICROBIOTEST
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01968707
- Sponsor's protocol ID
- EM-012760
- 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
- NCT01968707
- Acronym / sponsor ID
- EM-012760
- Keywords
- surgical prep, CHG, IPA
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 426 participants (actual)
- Lead sponsor
- Solventum US LLCIndustry (pharma, biotech, devices)
- Collaborators
- 3M
- Study start
- Oct 2013
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 24 Oct 2013 (estimated)
- Results
- Posted 9 Jun 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 determine 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 |
|---|---|---|
| ChloraPrep Hi-Lite Orange | Active comparator | Drug: ChloraPrep Hi-Lite OrangeApply 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: Normal salineApply 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 10.5 mL | Experimental | Drug: 3M CHG/IPA Prep Tint 10.5-mLApply 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 26-mL | Experimental | Drug: 3M CHG/IPA Prep Tint 26-mLApply 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 |
|---|---|---|
| ChloraPrep Hi-Lite OrangeAlso: ChloraPrep One-Step, Chlorhexidine gluconate 2% / Isopropyl alcohol 70%, Chlorhexidine gluconate 2% w/v / Isopropyl alcohol 70% v/v, 2% CHG / 70% IPAApply topically. | Drug | ChloraPrep Hi-Lite Orange |
| Normal salineAlso: 0.9% Sodium Chloride, Sterile Saline, 0.9% NaCl, SalineApply topically. | Drug | Normal Saline |
| 3M CHG/IPA Prep Tint 10.5-mLAlso: Chlorhexidine Gluconate and Isopropyl Alcohol, Chlorhexidine gluconate 2% / Isopropyl alcohol 70%, Chlorhexidine gluconate 2% w/v / Isopropyl alcohol 70% v/v, 2% CHG / 70% IPAApply topically. | Drug | 3M CHG/IPA Prep Tint 10.5 mL |
| 3M CHG/IPA Prep Tint 26-mLAlso: Chlorhexidine Gluconate and Isopropyl Alcohol, Chlorhexidine gluconate 2% / Isopropyl alcohol 70%, Chlorhexidine gluconate 2% w/v / Isopropyl alcohol 70% v/v, 2% CHG / 70% IPAApply topically | Drug | 3M CHG/IPA Prep Tint 26-mL |
Primary outcome
Responder Rate
Time frame: baseline, 10 minutes 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. 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.
6 secondary outcomes
Reduction of Skin Flora 6 Hours Post-treatment
Time frame: 6 hours
Reduction of Skin Flora 10 Minutes Post-treatment
Time frame: 10 minutes
Skin Flora Recovery 6-hours Post-treatment
Time frame: 6 hours post-treatment
Skin Flora Recovery 10 Minutes Post-treatment
Time frame: 10 minutes post-treatment
Skin Flora Baseline for the Abdominal and Inguinal Region.
Time frame: Baseline
Safety as Assessed by Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score
Time frame: Assessed at baseline (pre-treatment) and 10 minute post-treatment and 6 hour 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.
Muhammad H Bashir, MD, CCRP principal investigator
MICROBIOTEST
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 ChloraPrep Hi-Lite Orange, Normal saline and 3M CHG/IPA Prep Tint 10.5-mL in people with Bacterial Reduction on Skin Flora 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: 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 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 9 Jun 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 minutes post-product application and 6 hour 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.