Preoperative Skin PreparationPhase 2NCT03224299

Effectiveness of an Antimicrobial Agent for Preoperative Skin Preparation

A Phase 2 study testing OCT - clear, OCT- tinted and ChloraPrep in people with Preoperative Skin Preparation, run by Becton, Dickinson and Company at 2 sites in United States.

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

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Preoperative Skin Preparation
What is being tested?: OCT - clear, OCT- tinted and ChloraPrep
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 131 participants
Where: 2 sitesUnited States
Study dates: 21 Jun 2017to 3 Oct 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 may be of either sex, at least 18 years of age and of any race.
Subjects must be in good general health.
Subjects must read and sign an Informed Consent Form, Authorization to Use and Disclose Protected Health Information Form, and the List of Restricted Products prior to participating in the study.
Female subjects must complete a urine pregnancy test and have negative results documented before proceeding to treatment with test materials.
All subjects must meet Screening Day microbial baseline requirements established by the sponsor.

Who cannot join

Known allergies or sensitivities to sunscreens, deodorants, laundry detergents, fragrances, vinyl, latex (rubber), alcohols, soaps, metals, inks, dyes, tape adhesives, or to common antibacterial agents found in soaps, lotions, ointments, or particularly the active ingredients of the study product drug solutions.
Exposure of test sites to strong detergents, solvents, or other irritants within the 14-day product-restriction period or during the test period.
Exposure of test sites to antimicrobial agents, medicated soaps, medicated shampoos, or medicated lotions, use of biocide-treated pools or hot tubs, use of tanning beds, or sunbathing during the 14-day product-restriction period or during the test period.
Wear fabric softener-, bug repellent-, or UV-treated clothing during the 14-day product-restriction period or during the test period.
Use of systemic or topical antibiotic medications, steroid medications (other than for hormonal contraception or post-menopausal reasons), or any other product known to affect the normal microbial flora of the skin during the 14-day product-restriction period or during the test period.
A medical diagnosis of a physical condition, such as a current or recent severe illness, mitral valve prolapse with a heart murmur, congenital heart disease, hepatitis B, hepatitis C, an organ transplant, ports, or an immunocompromised condition such as AIDS (or HIV positive), lupus, medicated diabetes (Type 1 or 2), ulcerative colitis, Crohn's disease, asthma requiring daily medication, fibromyalgia or multiple sclerosis (medicated).

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Any tattoos or scars within 2 inches of the test sites; skin blemishes or warts may be permissible with the specific approval of the Principal Investigator or consulting physician.
Dermatoses, cuts, lesions, active skin rashes, scabs, breaks in the skin or other skin disorders within 6 inches, on, or around the test sites.
A currently active skin disease or inflammatory skin condition (for example, contact dermatitis, psoriasis, eczema) anywhere on the body that, in the opinion of the Principal Investigator, would compromise subject safety or study integrity.
Subjects who receive an irritation score of 1 (any redness, swelling, rash, or dryness present in any treatment area) for any individual skin condition prior to the Screening Day baseline or Treatment Day baseline sample collection.
Participation in another clinical study in the past 30 days or current participation in another clinical study at time of signing informed consent.
Showering, bathing, or swimming within the 72 hour period prior to sampling for baseline screening, the test day, or throughout the test period.
Pregnancy, plans to become pregnant or impregnate a sexual partner within the pre-test and test periods of the study, or nursing a child. All female subjects will be required to complete a urine pregnancy test on the day of test material application, prior to treatment. Both gender of subjects must be willing to use an acceptable method of contraception to prevent pregnancy for at least 14 days immediately preceding Treatment Day and throughout the duration of the study.
Any medical condition or use of any medications that, in the opinion of the Principal Investigator or Consulting Physician, would preclude participation.
Unwillingness to fulfill the performance requirements of the study.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

BioScience Laboratories
Bozeman, Montana, 59718
BioScience Laboratories
Butte, Montana, 59701

Other trials in United States

About this study

Objective of this study is to compare the antimicrobial properties of an investigational agent to an active control and a negative control when applied to specific body locations. Testing will be performed according to the procedures outlined in the Food and Drug Administration Tentative Final Monograph (TFM) for Effectiveness Testing of a Patient Preoperative Skin Preparation

Conditions: Preoperative Skin Preparation
Being tested: OCT - clear, OCT- tinted, ChloraPrep, Saline

What participants receive

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

OCT - clearDrug
Investigational Product #1: octenidine dihydrochloride in isopropyl alcohol in a single-use applicator - clear
OCT- tintedDrug
Investigational product #2: octenidine dihydrochloride in isopropyl alcohol in a single-use applicator - tinted
ChloraPrepOther
Active Control: ChloraPrep® - Hi-Lite Orange® applicator
SalineOther
Negative Control: sterile 0.9% saline applied with single use applicator

Study groups in NCT03224299
Study group	Role	What they receive
Investigational Product #1 (IP1)	Experimental	octenidine dihydrochloride in isopropyl alcohol in a single-use applicator - clear Receives: Drug: OCT - clear
Investigational Product #2 (IP2)	Experimental	octenidine dihydrochloride in isopropyl alcohol in a single-use applicator - tinted Receives: Drug: OCT- tinted
Active Control	Active comparator	ChloraPrep® - Hi-Lite Orange® applicator Receives: Other: ChloraPrep
Negative Control	Placebo comparator	sterile 0.9% saline applied with single use applicator Receives: Other: Saline

What is being measured

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

Antimicrobial Activity of the Investigational Products Compared to Control.
Measured: 10 minutes

Secondary outcomes (1)

Responder Rate at 6 Hours Post-application
Number of participants with bacterial reduction greater than or equal to baseline (0)
Measured: 6 hours

Timeline

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

21 Jun 20173 Oct 2017

First posted21 Jul 2017
Study start21 Jun 2017
Primary completion24 Aug 2017
Study completion3 Oct 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 Preoperative Skin PreparationStudies 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: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 131 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03224299
Sponsor's protocol ID: MPS-16IPVFT05
Status last verified: Mar 2021
First submitted: 10 Jul 2017
Last updated: 23 Apr 2021
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 23 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effectiveness of an Antimicrobial Agent for Preoperative Skin Preparation
ClinicalTrials.gov ID: NCT03224299
Acronym / sponsor ID: MPS-16IPVFT05
Conditions: Preoperative Skin Preparation
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 131 participants (actual)
Lead sponsor: Becton, Dickinson and CompanyIndustry (pharma, biotech, devices)
Study start: 21 Jun 2017 (actual)
Primary completion: 24 Aug 2017 (actual)
Study completion: 3 Oct 2017 (actual)
First posted: 21 Jul 2017 (actual)
Results: Posted 23 Apr 2021

Clinical summary

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

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
Investigational Product #1 (IP1)	Experimental	Drug: OCT - clearoctenidine dihydrochloride in isopropyl alcohol in a single-use applicator - clear
Investigational Product #2 (IP2)	Experimental	Drug: OCT- tintedoctenidine dihydrochloride in isopropyl alcohol in a single-use applicator - tinted
Active Control	Active comparator	Other: ChloraPrepChloraPrep® - Hi-Lite Orange® applicator
Negative Control	Placebo comparator	Other: Salinesterile 0.9% saline applied with single use applicator

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Subjects may be of either sex, at least 18 years of age and of any race.
Subjects must be in good general health.
Subjects must read and sign an Informed Consent Form, Authorization to Use and Disclose Protected Health Information Form, and the List of Restricted Products prior to participating in the study.
Female subjects must complete a urine pregnancy test and have negative results documented before proceeding to treatment with test materials.
All subjects must meet Screening Day microbial baseline requirements established by the sponsor.

Key exclusion criteria (15 listed)

Known allergies or sensitivities to sunscreens, deodorants, laundry detergents, fragrances, vinyl, latex (rubber), alcohols, soaps, metals, inks, dyes, tape adhesives, or to common antibacterial agents found in soaps, lotions, ointments, or particularly the active ingredients of the study product drug solutions.
Exposure of test sites to strong detergents, solvents, or other irritants within the 14-day product-restriction period or during the test period.
Exposure of test sites to antimicrobial agents, medicated soaps, medicated shampoos, or medicated lotions, use of biocide-treated pools or hot tubs, use of tanning beds, or sunbathing during the 14-day product-restriction period or during the test period.
Wear fabric softener-, bug repellent-, or UV-treated clothing during the 14-day product-restriction period or during the test period.
Use of systemic or topical antibiotic medications, steroid medications (other than for hormonal contraception or post-menopausal reasons), or any other product known to affect the normal microbial flora of the skin during the 14-day product-restriction period or during the test period.

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
OCT - clearInvestigational Product #1: octenidine dihydrochloride in isopropyl alcohol in a single-use applicator - clear	Drug	Investigational Product #1 (IP1)
OCT- tintedInvestigational product #2: octenidine dihydrochloride in isopropyl alcohol in a single-use applicator - tinted	Drug	Investigational Product #2 (IP2)
ChloraPrepActive Control: ChloraPrep® - Hi-Lite Orange® applicator	Other	Active Control
SalineNegative Control: sterile 0.9% saline applied with single use applicator	Other	Negative Control

Primary outcome

Antimicrobial Activity of the Investigational Products Compared to Control.
Time frame: 10 minutes

1 secondary outcome

Responder Rate at 6 Hours Post-application
Time frame: 6 hours

Results and safety

Results posted to the registry on 23 Apr 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Number of Participants	131	131
Number of Sites	424	424

Primary outcome: Antimicrobial Activity of the Investigational Products Compared to Control.

Time frame: 10 minutes. Mean (Standard Deviation). Unit: log10 CFU/cm^2

Measure	Investigational Product #1 n = 65	Investigational Product #2 n = 66	Active Control n = 66	Negative Control n = 65
Abdomen Baseline	3.85 (0.51)	3.91 (0.52)	3.87 (0.55)	3.84 (0.55)
Abdomen 30 seconds	0.98 (1.31)	1.05 (1.23)	1.34 (1.24)	3.42 (0.72)
Abdomen 10 minutes	1.20 (1.30)	0.91 (1.15)	1.08 (1.10)	3.12 (0.87)
Groin Baseline Groin Baseline	6.03 (0.52)	6.05 (0.59)	6.03 (0.53)	5.93 (0.50)
Groin 30 seconds	2.91 (1.26)	3.03 (1.16)	3.05 (1.19)	5.11 (0.41)
Groin 10 minutes	2.37 (1.34)	2.66 (1.37)	2.66 (1.42)	4.91 (0.43)

Investigational Product #1 vs Active Control: Mean Difference (Final Values): 0.12 (95% CI -0.44 to 0.69)
Investigational Product #1 vs Negative Control: Mean Difference (Final Values): 1.93 (95% CI 1.36 to 2.49)
Investigational Product #2 vs Active Control: Mean Difference (Final Values): -0.18 (95% CI -0.73 to 0.36)

Population analysed: Analysis only includes participants with required treatment day baseline bacterial counts at each anatomical site at baseline and non-missing data at 30 seconds and 10 minutes.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 6 hours. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
IP#1	0 of 65 (0%)	0 of 65 (0%)	0 of 65
IP#2	0 of 66 (0%)	0 of 66 (0%)	0 of 66
Active Control	0 of 66 (0%)	0 of 66 (0%)	0 of 66
Negative Control	0 of 65 (0%)	0 of 65 (0%)	0 of 65

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2021.
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.

The record lists no contact. Use the official record to reach the sponsor.

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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing OCT - clear, OCT- tinted and ChloraPrep in people with Preoperative Skin Preparation, run by Becton, Dickinson and Company at 2 sites 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 5 inclusion and 15 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 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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 Apr 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?

Antimicrobial Activity of the Investigational Products Compared to Control. (time frame: 10 minutes). 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 NCT03224299.

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 Apr 2021.