Preoperative Skin PreparationPhase 2NCT03140254

Evaluating Safety and Effectiveness of Octenidine Dihydrochloride

A Phase 2 study testing Chlorhexidine gluconate and N,N'-(1,10-decanediyldi-1(4H)-Pyridinyl-4-ylidene)-Bis-(1-octanamine) Dihydrochloride in people with Preoperative Skin Preparation, run by C. R. Bard 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

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Trial summary

The purpose of this study is to evaluate the safety and effectiveness of a topical antiseptic for preoperative skin preparation Read more about this study

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?: Chlorhexidine gluconate and N,N'-(1,10-decanediyldi-1(4H)-Pyridinyl-4-ylidene)-Bis-(1-octanamine) Dihydrochloride
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 145 participants
Where: 1 siteUnited States
Study dates: Sep 2016to 17 Mar 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 List of Restricted Products prior to participating in the study.
Female subjects must have a negative urine pregnancy test documented before treatment with test materials.
Screening day microbial baseline meeting minimum skin flora baseline requirements on abdomen and groin.

Who cannot join

Known allergies or sensitivities to sunscreens, deodorants, laundry detergents, fragrances, vinyl, latex (rubber), alcohols, metals, inks, or to common antibacterial agents found in soaps, lotions, or ointments.
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-treated clothing (including bug-repellent and 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, or an immunocompromised condition such as AIDS (or HIV positive), lupus, diabetes, Crohn's disease, asthma or medicated multiple sclerosis.

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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 at 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.
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

1 site in 1 country.

United States1 site

BioScience Laboratories
Butte, Montana, 59701

Other trials in United States

About this study

Official title: A RANDOMIZED, SINGLE-CENTER, BLINDED, PILOT CLINICAL EVALUATION OF THE ANTIMICROBIAL EFFECTIVENESS OF THERMALLY TREATED CLOTHS IMPREGNATED WITH 0.4% OCTENIDINE DIHYDROCHLORIDE AQUEOUS SOLUTION COMPARED TO THERMALLY TREATED CLOTHS IMPREGNATED WITH VEHICLE FORMULATION AND TO SAGE 2% CHLORHEXIDINE GLUCONATE CLOTH FOR PREOPERATIVE SKIN PREPARATION

The purpose of this study is to evaluate the safety and effectiveness of a topical antiseptic for preoperative skin preparation

Conditions: Preoperative Skin Preparation
Being tested: Chlorhexidine gluconate, N,N'-(1,10-decanediyldi-1(4H)-Pyridinyl-4-ylidene)-Bis-(1-octanamine) Dihydrochloride, Placebo

What participants receive

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

Chlorhexidine gluconateDrug
N,N'-(1,10-decanediyldi-1(4H)-Pyridinyl-4-ylidene)-Bis-(1-octanamine) DihydrochlorideDrug
PlaceboDrug

Study groups in NCT03140254
Study group	Role	What they receive
comparator	Active comparator	Chlorhexidine gluconate Receives: Drug: Chlorhexidine gluconate
experimental	Experimental	BDIP-0001 Receives: Drug: N,N'-(1,10-decanediyldi-1(4H)-Pyridinyl-4-ylidene)-Bis-(1-octanamine) Dihydrochloride
placebo	Placebo comparator	Vehicle Receives: Drug: Placebo

What is being measured

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

Percentage of Abdominal Site Responder Rates at 10 Minutes
Individual anatomical sites were considered responders based on the standards set forth in the Food and Drug Administration Tentative Final Monograph for Effectiveness Testing of a Patient Preoperative Skin Preparation (FR 59:116, 17 June 94, pp. 31450-31452). Individually treated abdomen sites with a 2 log10/cm^2 CFU reduction were considered "responders," and individually treated groin sites with a 3 log10/cm^2 CFU reduction were considered "responders."
Measured: 10 min
Percentage of Abdominal Site Responder Rates at 6 Hours
Individual anatomical sites were considered responders based on the standards set forth in the Food and Drug Administration Tentative Final Monograph for Effectiveness Testing of a Patient Preoperative Skin Preparation (FR 59:116, 17 June 94, pp. 31450-31452). Individually treated abdomen sites with a log10/cm^2 CFU reduction greater than or equal to 0 were considered responders.
Measured: 6 hours
Percentage of Groin Site Responder Rate at 6 Hours
Individual anatomical sites were considered responders based on the standards set forth in the Food and Drug Administration Tentative Final Monograph for Effectiveness Testing of a Patient Preoperative Skin Preparation (FR 59:116, 17 June 94, pp. 31450-31452). Individually treated groin sites with a log10/cm^2 CFU reduction greater than or equal to 0 were considered responders.
Measured: 6 hours
Percentage of Groin Sites Responder Rates at 10 Minutes
Participants were considered responders based on the standards set forth in the Food and Drug Administration Tentative Final Monograph for Effectiveness Testing of a Patient Preoperative Skin Preparation (FR 59:116, 17 June 94, pp. 31450-31452). Individually treated groin sites with a 3 log10/cm^2 CFU reduction were considered "responders."
Measured: 10 minutes

Timeline

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

Sep 201617 Mar 2017

First posted4 May 2017
Study startSep 2016
Primary completion17 Mar 2017
Study completion17 Mar 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.
More trials run by C. R. BardThe sponsor's other registered studies.
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: Double blind
Who is masked: Participant, Investigator
Enrolment: 145 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03140254
Sponsor's protocol ID: MPS-16IPVAW01
Status last verified: Nov 2025
First submitted: 19 Sep 2016
Last updated: 11 Dec 2025
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 11 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A RANDOMIZED, SINGLE-CENTER, BLINDED, PILOT CLINICAL EVALUATION OF THE ANTIMICROBIAL EFFECTIVENESS OF THERMALLY TREATED CLOTHS IMPREGNATED WITH 0.4% OCTENIDINE DIHYDROCHLORIDE AQUEOUS SOLUTION COMPARED TO THERMALLY TREATED CLOTHS IMPREGNATED WITH VEHICLE FORMULATION AND TO SAGE 2% CHLORHEXIDINE GLUCONATE CLOTH FOR PREOPERATIVE SKIN PREPARATION
ClinicalTrials.gov ID: NCT03140254
Acronym / sponsor ID: MPS-16IPVAW01
Conditions: Preoperative Skin Preparation
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 145 participants (actual)
Lead sponsor: C. R. BardIndustry (pharma, biotech, devices)
Study start: Sep 2016 (actual)
Primary completion: 17 Mar 2017 (actual)
Study completion: 17 Mar 2017 (actual)
First posted: 4 May 2017 (actual)
Results: Posted 3 Aug 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 evaluate the safety and effectiveness of a topical antiseptic for preoperative skin preparation

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 3

Arm	Type	Receives
comparator	Active comparator	Drug: Chlorhexidine gluconateChlorhexidine gluconate
experimental	Experimental	Drug: N,N'-(1,10-decanediyldi-1(4H)-Pyridinyl-4-ylidene)-Bis-(1-octanamine) DihydrochlorideBDIP-0001
placebo	Placebo comparator	Drug: PlaceboVehicle

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 List of Restricted Products prior to participating in the study.
Female subjects must have a negative urine pregnancy test documented before treatment with test materials.
Screening day microbial baseline meeting minimum skin flora baseline requirements on abdomen and groin.

Key exclusion criteria (15 listed)

Known allergies or sensitivities to sunscreens, deodorants, laundry detergents, fragrances, vinyl, latex (rubber), alcohols, metals, inks, or to common antibacterial agents found in soaps, lotions, or ointments.
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-treated clothing (including bug-repellent and 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
Chlorhexidine gluconate	Drug	comparator
N,N'-(1,10-decanediyldi-1(4H)-Pyridinyl-4-ylidene)-Bis-(1-octanamine) Dihydrochloride	Drug	experimental
Placebo	Drug	placebo

Primary outcome

Percentage of Abdominal Site Responder Rates at 10 Minutes
Time frame: 10 min
Individual anatomical sites were considered responders based on the standards set forth in the Food and Drug Administration Tentative Final Monograph for Effectiveness Testing of a Patient Preoperative Skin Preparation (FR 59:116, 17 June 94, pp. 31450-31452). Individually treated abdomen sites with a 2 log10/cm^2 CFU reduction were considered "responders," and individually treated groin sites with a 3 log10/cm^2 CFU reduction were considered "responders."
Percentage of Abdominal Site Responder Rates at 6 Hours
Time frame: 6 hours
Individual anatomical sites were considered responders based on the standards set forth in the Food and Drug Administration Tentative Final Monograph for Effectiveness Testing of a Patient Preoperative Skin Preparation (FR 59:116, 17 June 94, pp. 31450-31452). Individually treated abdomen sites with a log10/cm^2 CFU reduction greater than or equal to 0 were considered responders.
Percentage of Groin Site Responder Rate at 6 Hours
Time frame: 6 hours
Individual anatomical sites were considered responders based on the standards set forth in the Food and Drug Administration Tentative Final Monograph for Effectiveness Testing of a Patient Preoperative Skin Preparation (FR 59:116, 17 June 94, pp. 31450-31452). Individually treated groin sites with a log10/cm^2 CFU reduction greater than or equal to 0 were considered responders.
Percentage of Groin Sites Responder Rates at 10 Minutes
Time frame: 10 minutes
Participants were considered responders based on the standards set forth in the Food and Drug Administration Tentative Final Monograph for Effectiveness Testing of a Patient Preoperative Skin Preparation (FR 59:116, 17 June 94, pp. 31450-31452). Individually treated groin sites with a 3 log10/cm^2 CFU reduction were considered "responders."

Results and safety

Results posted to the registry on 3 Aug 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
Treated Participants	145	144

Primary outcome: Percentage of Abdominal Site Responder Rates at 10 Minutes

Time frame: 10 min. Mean (95% Confidence Interval). Unit: percentage of abdomen sites

Measure	Investigational Product n = 77	Active Control n = 81	Vehicle Control n = 34
Value	79.2 (65.7 to 88.3)	85.4 (72.8 to 92.8)	52.6 (31.7 to 72.7)

Population analysed: Number of individual sites that met treatment day bacterial requirements on the abdomen for analysis are IP = 48, AC = 48, VC = 19

Primary outcome: Percentage of Abdominal Site Responder Rates at 6 Hours

Time frame: 6 hours. Mean (95% Confidence Interval). Unit: percentage of abdomen sites

Measure	Investigational Product n = 77	Active Control n = 81	Vehicle Control n = 34
Value	89.6 (77.8 to 95.5)	100.0 (92.6 to 100.0)	94.7 (75.4 to 99.1)

Population analysed: Number of abdomen sites passing treatment day bacterial requirements were analyzed for responder rates. The number of anatomical sites meeting treatment day bacterial requirements were IP = 48, AC = 48, VC = 19 for the abdomen.

Primary outcome: Percentage of Groin Site Responder Rate at 6 Hours

Time frame: 6 hours. Mean (95% Confidence Interval). Unit: percentage of groin sites

Measure	Investigational Product n = 72	Active Control n = 74	Vehicle Control n = 21
Value	100 (93 to 100)	98 (89.7 to 99.7)	100 (82.4 to 100)

Population analysed: Individual sites that met treatment day bacterial requirements were analyzed for responder rates. Number of sites passing treatment day bacterial requirements on the groin were IP = 51, AC = 51, and VC = 18.

Primary outcome: Percentage of Groin Sites Responder Rates at 10 Minutes

Time frame: 10 minutes. Mean (95% Confidence Interval). Unit: percentage of groin sites

Measure	Investigational Product n = 73	Active Control n = 74	Vehicle Control n = 21
Value	72.5 (59.1 to 82.9)	74.5 (61.1 to 84.5)	55.6 (33.7 to 75.4)

Population analysed: Number of individually treated groin sites that passed treatment day bacterial requirements were IP = 51, AC = 51, and VC = 18.

Adverse events

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

Group	Serious adverse events	Other adverse events	Deaths
All Participants	0 of 145 (0%)	0 of 145 (0%)	0 of 145

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2025.
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.

Kevin Burroughs study director

Becton, Dickinson and Company

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 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 11 Dec 2025. 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 3 Aug 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?

Percentage of Abdominal Site Responder Rates at 10 Minutes (time frame: 10 min). The study lists 4 primary outcomes in all. 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 NCT03140254.

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 11 Dec 2025.