Bacterial Reduction Post-product ApplicationPhase 3NCT02203591
In Vivo Efficacy Study of Patient Preoperative Preps
A Phase 3 study testing 3M CHG/IPA Prep C, 3M CHG/IPA Prep CH and ChloraPrep in people with Bacterial Reduction Post-product Application, run by 3M at 1 site in United States.
Trial summary
The objective of this study is to demonstrate 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 Post-product Application
- What is being tested?
- 3M CHG/IPA Prep C, 3M CHG/IPA Prep CH and ChloraPrep
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 738 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2014to Mar 2015
- 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 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 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
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 objective of this study is to demonstrate 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 site, a responder is defined as a subject with a 2-log10/cm2 bacterial reduction at 10 minutes and for whom the skin flora does not return to baseline at 6 hours.
On the inguinal site, a responder is defined as a subject with a 3-log10/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 C, 3M CHG/IPA Prep CH, ChloraPrep, Normal 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 CDrug
Also called Chlorhexidine Gluconate and Isopropyl Alcohol, Chlorhexidine gluconate 2% / Isopropyl alcohol 70%, CHG 2%/IPA 70%
Apply 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 CHDrug
Also called Chlorhexidine Gluconate and Isopropyl Alcohol, Chlorhexidine gluconate 2% / Isopropyl alcohol 70%, CHG 2%/IPA 70%
Apply topically for 30 seconds to the abdominal region or 2 minutes to the inguinal region, and allow to dry for 3 minutes.
ChloraPrepDrug
Also called ChloraPrep Patient Preoperative Skin Preparation, ChloraPrep One-Step, Chlorhexidine gluconate 2% / Isopropyl alcohol 70%, CHG2%/IPA 70%
Apply topically for 30 seconds to the abdominal region or 2 minutes to the inguinal region, and allow to dry for 3 minutes.
Normal SalineDrug
Also called Sodium Chloride 0.9%, Saline
Apply topically for 30 seconds to the abdominal region or 2 minutes to the inguinal region, and allow to dry for 3 minutes.
| Study group | Role | What they receive |
|---|---|---|
| 3M CHG/IPA Prep C | 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 C |
| 3M CHG/IPA Prep CH | 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 CH |
| ChloraPrep | 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 |
| 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 |
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 is a subject with a 2 log10/cm^2 bacterial reduction at 10 minutes and for whom the skin flora does not return to baseline at the 6-hour sample collection time.
On the inguinal region a responder is a subject with a 3 log10/cm^2 bacterial reduction at 10 minutes and for whom the skin flora does not return to baseline at the 6-hour sample collection time.
Measured: baseline, 10 minutes post-product application and 6 hours post-product application
Alternative Primary
10 minute log reduction
Measured: Baseline and 10 minutes
Secondary outcomes (8)
Reduction of Skin Flora 6 Hours Post-treatment
Log10/cm^2 reduction of skin flora, relative to treatment day baseline, 6 hours post-treatment application
Measured: 6 hours
Reduction of Skin Flora 10 Minutes Post-treatment
Log10/cm^2 reduction of skin flora, relative to treatment day baseline (log10/cm^2) at 10 minutes post-treatment application
Measured: 10 minutes
Skin Flora Recovery 6-hours Post-treatment
Log10/cm^2 recovery of skin flora at 6 hours following application of treatment
Measured: 6 hours post-treatment
Skin Flora Recovery 10 Minutes Post-treatment
Log10/cm^2 recovery of skin flora at 10 minutes following application of study treatments.
Measured: 10 minute post-product application
Skin Flora Baseline for the Abdomen and Inguinal Region.
Log10/cm^2 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 = moderate, 3 = severe.
Measured: Baseline
Safety Assessed as 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=moderate, 3=severe
Measured: 10 minutes post-treatment
Safety as Assessed by Skin Irritation Score
Skin irritation rating (0-3) scores for dryness, edema, erythema and rash; 0 = no reaction, 1 = mild, 2 = moderate, 3 = severe.
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 posted30 Jul 2014 (estimated)
- Study startJul 2014
- Primary completionMar 2015
- Study completionMar 2015
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 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
- 738 participants (actual)
Sponsor and investigators
- Lead sponsor
- 3M
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jamie Miller, ADN, Principal investigator, Independent Consultant
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02203591
- Sponsor's protocol ID
- EM-013260
- Status last verified
- Oct 2020
- First submitted
- 28 Jul 2014
- Last updated
- 23 Nov 2020
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2020. 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
- NCT02203591
- Acronym / sponsor ID
- EM-013260
- Keywords
- surgical skin prep, CHG, IPA
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 738 participants (actual)
- Lead sponsor
- 3MIndustry (pharma, biotech, devices)
- Study start
- Jul 2014
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 30 Jul 2014 (estimated)
- Results
- Posted 23 Nov 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to demonstrate 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 site, a responder is defined as a subject with a 2-log10/cm2 bacterial reduction at 10 minutes and for whom the skin flora does not return to baseline at 6 hours.
On the inguinal site, a responder is defined as a subject with a 3-log10/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 C | Experimental | Drug: 3M CHG/IPA Prep CApply 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 CH | Experimental | Drug: 3M CHG/IPA Prep CHApply topically for 30 seconds to the abdominal region or 2 minutes to the inguinal region, and allow to dry for 3 minutes. |
| ChloraPrep | Active comparator | Drug: ChloraPrepApply 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. |
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 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 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 |
|---|---|---|
| 3M CHG/IPA Prep CAlso: Chlorhexidine Gluconate and Isopropyl Alcohol, Chlorhexidine gluconate 2% / Isopropyl alcohol 70%, CHG 2%/IPA 70%Apply topically for 30 seconds to the abdominal region or 2 minutes to the inguinal region, and allow to dry for 3 minutes. | Drug | 3M CHG/IPA Prep C |
| 3M CHG/IPA Prep CHAlso: Chlorhexidine Gluconate and Isopropyl Alcohol, Chlorhexidine gluconate 2% / Isopropyl alcohol 70%, CHG 2%/IPA 70%Apply topically for 30 seconds to the abdominal region or 2 minutes to the inguinal region, and allow to dry for 3 minutes. | Drug | 3M CHG/IPA Prep CH |
| ChloraPrepAlso: ChloraPrep Patient Preoperative Skin Preparation, ChloraPrep One-Step, Chlorhexidine gluconate 2% / Isopropyl alcohol 70%, CHG2%/IPA 70%Apply topically for 30 seconds to the abdominal region or 2 minutes to the inguinal region, and allow to dry for 3 minutes. | Drug | ChloraPrep |
| Normal SalineAlso: Sodium Chloride 0.9%, SalineApply topically for 30 seconds to the abdominal region or 2 minutes to the inguinal region, and allow to dry for 3 minutes. | Drug | Normal Saline |
Primary outcome
Responder Rate
Time frame: baseline, 10 minutes post-product application and 6 hours post-product application
On the abdominal region a responder is a subject with a 2 log10/cm^2 bacterial reduction at 10 minutes and for whom the skin flora does not return to baseline at the 6-hour sample collection time. On the inguinal region a responder is a subject with a 3 log10/cm^2 bacterial reduction at 10 minutes and for whom the skin flora does not return to baseline at the 6-hour sample collection time.
Alternative Primary
Time frame: Baseline and 10 minutes
10 minute log reduction
8 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 minute post-product application
Skin Flora Baseline for the Abdomen and Inguinal Region.
Time frame: Baseline
Safety as Assessed by Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score
Time frame: Baseline
Safety Assessed as Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score
Time frame: 10 minutes post-treatment
Safety as Assessed by Skin Irritation Score
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 23 Nov 2020.
- 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.
Jamie Miller, ADN principal investigator
Independent Consultant
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 C, 3M CHG/IPA Prep CH and ChloraPrep in people with Bacterial Reduction Post-product Application, run by 3M 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 23 Nov 2020. 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 23 Nov 2020). 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 hours post-product application). 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 23 Nov 2020.