Bacterial Recovery of Skin Flora Post-product ApplicationPhase 2NCT03155178

In Vivo Preoperative Skin Preparation Persistence Evaluation

A Phase 2 study testing 3M CHG/IPA Prep and ChloraPrep in people with Bacterial Recovery of Skin Flora Post-product Application, run by Solventum US LLC.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Evaluate persistent antimicrobial effectiveness of chlorhexidine gluconate containing products on abdominal and inguinal sites following a saline and wipe challenge. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Bacterial Recovery of Skin Flora Post-product Application
What is being tested?: 3M CHG/IPA Prep and ChloraPrep
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 69 participants
Where: No sites listed yet
Study dates: 5 Dec 2016to 25 Apr 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
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

About this study

Official title: 96-hour Antimicrobial Persistence Assessment Following Exposure to Saline and Blotting

Evaluate persistent antimicrobial effectiveness of chlorhexidine gluconate containing products on abdominal and inguinal sites following a saline and wipe challenge.

Read the detailed description

Persistent antimicrobial effectiveness was evaluated by measuring the regrowth of normal skin flora at 48 hours, 72 hours and 96 hours, and the suppression of regrowth relative to post-prep (10-min) at 48 hours, 72 hours and 96 hours.

Conditions: Bacterial Recovery of Skin Flora Post-product Application
Being tested: 3M CHG/IPA Prep, ChloraPrep

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 Chlorhexidine Gluconate and Isopropyl Alcohol, CHG/IPA
Apply topically to intact dry skin (abdominal site) for 30 seconds or moist skin (inguinal site) for 2 minutes.
ChloraPrepDrug
Also called Chlorhexidine Gluconate and Isopropyl Alcohol, Chlorhexidine 2% / Isopropyl alcohol 70%, CHG/IPA, ChloraPrep One-Step
Apply topically to intact dry skin (abdominal site) for 30 seconds or moist skin (inguinal site) for 2 minutes.

Study groups in NCT03155178
Study group	Role	What they receive
3M CHG/IPA Prep	Experimental	Apply topically for 30 seconds (abdominal site) or 2 minutes (inguinal site), and allow to dry for 3 minutes. Receives: Drug: 3M CHG/IPA Prep
ChloraPrep	Active comparator	Apply topically for 30 seconds (abdominal site) or 2 minutes (inguinal site), and allow to dry for 3 minutes. Receives: Drug: ChloraPrep

What is being measured

The primary outcome is the main question the study is designed to answer.

Measurement of Skin Flora Recovery Post-prep Application
The primary measure of persistence is the suppression of regrowth recovery relative to baseline (log10 CFU/cm^2) of skin flora at 3 defined post-treatment sampling times.
Measured: Baseline, 48-hours post-treatment, 72-hours post-treatment and 96-hours post-treatment

Secondary outcomes (1)

Change in Skin Flora Relative to 10 Minutes Post-prep Application
Log10 CFU/cm^2 regrowth of skin flora, relative to 10-minute post-treatment log10 CFU/cm^2, at 3 defined post-treatment sampling times.
Measured: 10-minute post-treatment, 48-hours post-treatment, 72-hours post-treatment and 96-hours post-treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

5 Dec 201625 Apr 2017

First posted16 May 2017
Study start5 Dec 2016
Primary completion25 Apr 2017
Study completion25 Apr 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 Bacterial Recovery of 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 2
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 69 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03155178
Sponsor's protocol ID: EM-013953
Status last verified: Sep 2024
First submitted: 11 May 2017
Last updated: 2 Oct 2024
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: 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: 96-hour Antimicrobial Persistence Assessment Following Exposure to Saline and Blotting
ClinicalTrials.gov ID: NCT03155178
Acronym / sponsor ID: EM-013953
Conditions: Bacterial Recovery of Skin Flora Post-product Application
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 69 participants (actual)
Lead sponsor: Solventum US LLCIndustry (pharma, biotech, devices)
Collaborators: 3M
Study start: 5 Dec 2016 (actual)
Primary completion: 25 Apr 2017 (actual)
Study completion: 25 Apr 2017 (actual)
First posted: 16 May 2017 (actual)
Results: Posted 28 Feb 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Evaluate persistent antimicrobial effectiveness of chlorhexidine gluconate containing products on abdominal and inguinal sites following a saline and wipe challenge.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
3M CHG/IPA Prep	Experimental	Drug: 3M CHG/IPA PrepApply topically for 30 seconds (abdominal site) or 2 minutes (inguinal site), and allow to dry for 3 minutes.
ChloraPrep	Active comparator	Drug: ChloraPrepApply topically for 30 seconds (abdominal site) or 2 minutes (inguinal site), 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 PrepAlso: Chlorhexidine Gluconate and Isopropyl Alcohol, CHG/IPAApply topically to intact dry skin (abdominal site) for 30 seconds or moist skin (inguinal site) for 2 minutes.	Drug	3M CHG/IPA Prep
ChloraPrepAlso: Chlorhexidine Gluconate and Isopropyl Alcohol, Chlorhexidine 2% / Isopropyl alcohol 70%, CHG/IPA, ChloraPrep One-StepApply topically to intact dry skin (abdominal site) for 30 seconds or moist skin (inguinal site) for 2 minutes.	Drug	ChloraPrep

Primary outcome

Measurement of Skin Flora Recovery Post-prep Application
Time frame: Baseline, 48-hours post-treatment, 72-hours post-treatment and 96-hours post-treatment
The primary measure of persistence is the suppression of regrowth recovery relative to baseline (log10 CFU/cm^2) of skin flora at 3 defined post-treatment sampling times.

1 secondary outcome

Change in Skin Flora Relative to 10 Minutes Post-prep Application
Time frame: 10-minute post-treatment, 48-hours post-treatment, 72-hours post-treatment and 96-hours post-treatment

Results and safety

Results posted to the registry on 28 Feb 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
3M CHG/IPA Prep/Abdominal Region	69	62
ChloraPrep/Abdominal Region	69	62
3M CHG/IPA Prep/Inguinal Region	69	62
ChloraPrep/Inguinal Region	69	62

Primary outcome: Measurement of Skin Flora Recovery Post-prep Application

Time frame: Baseline, 48-hours post-treatment, 72-hours post-treatment and 96-hours post-treatment. Mean (Standard Deviation). Unit: log10 CFU/cm^2

Measure	Experimental Prep - Abdominal Site n = 62	Active Comparator Prep - Abdominal Site n = 62	Experimental Prep - Inguinal Site n = 62	Active Comparator Prep - Inguinal Site n = 62
48 hour timepoint	1.39 (1.27)	1.15 (1.02)	1.97 (1.19)	1.82 (1.10)
72 hour timepoint	0.89 (1.11)	0.92 (1.05)	1.94 (1.41)	2.13 (1.30)
96 hour timepoint	1.21 (1.20)	1.17 (1.18)	2.39 (1.48)	2.46 (1.52)

Experimental Prep - Abdominal Site vs Active Comparator Prep - Abdominal Site: Mean Difference (Final Values): -0.23 (95% CI -0.53 to 0.07), p = 0.13, Paired t-test
Experimental Prep - Abdominal Site vs Active Comparator Prep - Abdominal Site: Mean Difference (Final Values): 0.04 (95% CI -0.23 to 0.30), p = 0.78, Paired t-test
Experimental Prep - Abdominal Site vs Active Comparator Prep - Abdominal Site: Mean Difference (Final Values): -0.05 (95% CI -0.38 to 0.29), p = 0.77, Paired t-test

Population analysed: The primary analysis data set used a Modified Intent to Treat population. Subjects were excluded who did not meet the treatment day baseline requirements of either \> or equal to 3.0 log10 CFU/cm\^2 on the abdomen test site or \> or equal to 5.0 log10 CFU/cm\^2 on the inguinal test site.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse events were collected during the treatment phase of the study. Product remained on each subject's skin for approximately 96 hours.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
3M CHG/IPA Prep Abdominal Region	0 of 69 (0%)	0 of 69 (0%)	0 of 69
ChloraPrep CHG/IPA Abdominal Region	0 of 69 (0%)	0 of 69 (0%)	0 of 69
3M CHG/IPA Prep Inguinal Region	0 of 69 (0%)	0 of 69 (0%)	0 of 69
ChloraPrep CHG/IPA Inguinal Region	0 of 69 (0%)	0 of 69 (0%)	0 of 69

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.
Individual participant dataSharing planned: No

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

Evic / Eurofins

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing 3M CHG/IPA Prep and ChloraPrep in people with Bacterial Recovery of Skin Flora Post-product Application, run by Solventum US LLC.

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.

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 28 Feb 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?

Measurement of Skin Flora Recovery Post-prep Application (time frame: Baseline, 48-hours post-treatment, 72-hours post-treatment and 96-hours post-treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03155178.

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.