Bacterial Recovery of Skin Flora Post-Product ApplicationPhase 2NCT02447497

In Vivo Patient Preoperative Skin Prep Persistence

A Phase 2 study testing 3M CHG/IPA Surgical Skin Preparation - Abdominal Region, Normal Saline - Abdominal Region and 3M CHG/IPA Surgical Skin Preparation - Inguinal Region in people with Bacterial Recovery of Skin Flora Post-Product Application, run by Solventum US LLC at 1 site in United States.

Completed

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

Official record

Search all trials

Trial summary

The objective of the study is to demonstrate persistence of the 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 Recovery of Skin Flora Post-Product Application
What is being tested?: 3M CHG/IPA Surgical Skin Preparation - Abdominal Region, Normal Saline - Abdominal Region and 3M CHG/IPA Surgical Skin Preparation - Inguinal Region
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 27 participants
Where: 1 siteUnited States
Study dates: Mar 2015to Apr 2015
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 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

MicroBioTest
Sterling, Virginia, 20164

Other trials in United States

About this study

Official title: Assessment of Antimicrobial Persistence of 3M CHG/IPA Preoperative Skin Preparation Against Resident Flora on the Abdominal and Inguinal Regions

The objective of the study is to demonstrate persistence of the CHG/IPA Prep on skin flora of the abdominal and inguinal regions of human subjects.

Read the detailed description

The objective of the study is to demonstrate persistence of the CHG/IPA Prep versus a saline placebo on skin flora of the abdominal and inguinal regions of human subjects as measured by change in microbial flora relative to baseline.

Conditions: Bacterial Recovery of Skin Flora Post-Product Application
Being tested: 3M CHG/IPA Surgical Skin Preparation - Abdominal Region, Normal Saline - Abdominal Region, 3M CHG/IPA Surgical Skin Preparation - Inguinal Region, Normal Saline - Inguinal Region

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

3M CHG/IPA Surgical Skin Preparation - Abdominal RegionDrug
Also called SoluPrep
Chlorhexidine gluconate 2% / Isopropyl alcohol 70%
Normal Saline - Abdominal RegionOther
0.9% sodium chloride applied with foam applicator
3M CHG/IPA Surgical Skin Preparation - Inguinal RegionDrug
Also called SoluPrep
Chlorhexidine gluconate 2% / Isopropyl alcohol 70%
Normal Saline - Inguinal RegionOther
0.9% sodium chloride applied with foam applicator

Study groups in NCT02447497
Study group	Role	What they receive
3M CHG/IPA - Abdominal Region	Experimental	Apply Chlorhexidine (CHG) 2% / Isopropyl alcohol (IPA) 70% for 30 seconds and allow to dry for 3 minutes. Receives: Drug: 3M CHG/IPA Surgical Skin Preparation - Abdominal Region
Normal Saline - Abdominal Region	Placebo comparator	Apply 0.9% sodium chloride with applicator for 30 seconds and allow to dry for 3 minutes. Receives: Other: Normal Saline - Abdominal Region
3M CHG/IPA - Inguinal Region	Experimental	Apply Chlorhexidine (CHG) 2% / Isopropyl alcohol (IPA) 70% for 30 seconds and allow to dry for 3 minutes. Receives: Drug: 3M CHG/IPA Surgical Skin Preparation - Inguinal Region
Normal Saline - Inguinal Region	Placebo comparator	Apply 0.9% sodium chloride with applicator for 30 seconds and allow to dry for 3 minutes. Receives: Other: Normal Saline - Inguinal Region

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 Relative to Baseline
The primary measure of persistence is the suppression of regrowth recovery relative to baseline (log10 CFU/cm^2) of skin flora at two defined post-prep sampling times relative to baseline.
Measured: Baseline, 48 hours and 72 hours post-prep application

Secondary outcomes (2)

Safety as Assessed by Skin Irritation Scores Coded by Study Staff
For the conditions of erythema, edema, rash, and dryness, a rating of 0 (no reaction), 1 (mild and/or transient, limited to sensitive area), 2 (moderate, persisting over much of the product-exposed area), or 3 (severe, extending over most or all of the product-exposed area) was recorded on the Skin Irritation Rating form of the eCRF.
Measured: 48 hours and 72 hours post-product application
Safety as Assessed by Adverse Events
Number of subjects with adverse events as self-reported or identified by study staff
Measured: To 72 hours post treatment

Timeline

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

Mar 2015Apr 2015

First posted19 May 2015 (estimated)
Study startMar 2015
Primary completionApr 2015
Study completionApr 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 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: 27 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02447497
Sponsor's protocol ID: EM-05-013509
Status last verified: Sep 2024
First submitted: 8 May 2015
Last updated: 2 Oct 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
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: Assessment of Antimicrobial Persistence of 3M CHG/IPA Preoperative Skin Preparation Against Resident Flora on the Abdominal and Inguinal Regions
ClinicalTrials.gov ID: NCT02447497
Acronym / sponsor ID: EM-05-013509
Conditions: Bacterial Recovery of Skin Flora Post-Product Application
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 27 participants (actual)
Lead sponsor: Solventum US LLCIndustry (pharma, biotech, devices)
Collaborators: 3M
Study start: Mar 2015
Primary completion: Apr 2015 (actual)
Study completion: Apr 2015 (actual)
First posted: 19 May 2015 (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 the study is to demonstrate persistence of the CHG/IPA Prep on skin flora of the abdominal and inguinal regions of human subjects.

Detailed description

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 - Abdominal Region	Experimental	Drug: 3M CHG/IPA Surgical Skin Preparation - Abdominal RegionApply Chlorhexidine (CHG) 2% / Isopropyl alcohol (IPA) 70% for 30 seconds and allow to dry for 3 minutes.
Normal Saline - Abdominal Region	Placebo comparator	Other: Normal Saline - Abdominal RegionApply 0.9% sodium chloride with applicator for 30 seconds and allow to dry for 3 minutes.
3M CHG/IPA - Inguinal Region	Experimental	Drug: 3M CHG/IPA Surgical Skin Preparation - Inguinal RegionApply Chlorhexidine (CHG) 2% / Isopropyl alcohol (IPA) 70% for 30 seconds and allow to dry for 3 minutes.
Normal Saline - Inguinal Region	Placebo comparator	Other: Normal Saline - Inguinal RegionApply 0.9% sodium chloride with applicator for 30 seconds 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 Surgical Skin Preparation - Abdominal RegionAlso: SoluPrepChlorhexidine gluconate 2% / Isopropyl alcohol 70%	Drug	3M CHG/IPA - Abdominal Region
Normal Saline - Abdominal Region0.9% sodium chloride applied with foam applicator	Other	Normal Saline - Abdominal Region
3M CHG/IPA Surgical Skin Preparation - Inguinal RegionAlso: SoluPrepChlorhexidine gluconate 2% / Isopropyl alcohol 70%	Drug	3M CHG/IPA - Inguinal Region
Normal Saline - Inguinal Region0.9% sodium chloride applied with foam applicator	Other	Normal Saline - Inguinal Region

Primary outcome

Measurement of Skin Flora Recovery Post-prep Application Relative to Baseline
Time frame: Baseline, 48 hours and 72 hours 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 two defined post-prep sampling times relative to baseline.

2 secondary outcomes

Safety as Assessed by Skin Irritation Scores Coded by Study Staff
Time frame: 48 hours and 72 hours post-product application
Safety as Assessed by Adverse Events
Time frame: To 72 hours post treatment

Results and safety

Results posted to the registry on 23 Nov 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 - Abdominal Region	25	19
Normal Saline - Abdominal Region	25	19
3M CHG/IPA Prep - Inguinal Region	23	21
Normal Saline - Inguinal Region	23	21

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

Time frame: Baseline, 48 hours and 72 hours post-prep application. Mean (Standard Deviation). Unit: Log10 CFU/cm^2

Measure	Normal Saline - Abdominal Region n = 20	3M CHG/IPA Prep - Abdominal Region n = 19	Normal Saline - Inguinal Region n = 21	3M CHG/IPA Prep - Inguinal Region n = 21
48-hour timepoint	0.91 (0.78)	2.81 (0.97)	0.59 (0.79)	2.96 (1.07)
72-hour timepoint	0.93 (1.07)	2.44 (1.34)	0.51 (0.73)	2.91 (1.60)

Normal Saline - Abdominal Region vs 3M CHG/IPA Prep - Abdominal Region: Mean Difference (Final Values): 1.97 (95% CI 0.51 to 4.10), p <0.0001, Paired t-test
Normal Saline - Inguinal Region vs 3M CHG/IPA Prep - Inguinal Region: Mean Difference (Final Values): 2.37 (95% CI 0.60 to 5.75), p = 0.0001, Paired t-test
Normal Saline - Abdominal Region vs 3M CHG/IPA Prep - Abdominal Region: Mean Difference (Final Values): 1.51 (95% CI 0.17 to 3.75), p = 0.0001, Paired t-test

Population analysed: Number analyzed includes subjects who met baseline requirements

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were collected during the treatment phase of the study. The product remained on the skin for approximately 72 hours post.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
3M CHG/IPA - Abdomen	0 of 25 (0%)	0 of 25 (0%)	0 of 25
Normal Saline - Abdomen	0 of 25 (0%)	0 of 25 (0%)	0 of 25
3M CHG/IPA - Inguinal	0 of 23 (0%)	0 of 23 (0%)	0 of 23
Normal Saline - Inguinal	0 of 23 (0%)	0 of 23 (0%)	0 of 23

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.

Muhammad H Bashir, MD, CCRP principal investigator

MicroBioTest Inc.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 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 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?

Measurement of Skin Flora Recovery Post-prep Application Relative to Baseline (time frame: Baseline, 48 hours and 72 hours post-prep application). 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 NCT02447497.

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.