NCT02530541

Brief Summary

Pilot study to evaluate and compare activity of preoperative preparation with comparator

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P50-P75 for phase_1 healthy

Timeline
Completed

Started Apr 2014

Longer than P75 for phase_1 healthy

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2014

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 16, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 21, 2015

Completed
5.7 years until next milestone

Results Posted

Study results publicly available

April 30, 2021

Completed
Last Updated

April 30, 2021

Status Verified

September 1, 2020

Enrollment Period

3 months

First QC Date

August 16, 2015

Results QC Date

November 25, 2015

Last Update Submit

April 29, 2021

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • Log Reduction of Bacterial Flora on the Abdomen and Groin

    Evaluate the Log Reduction of normal flora at various timepoints.

    10 min, 6 hr and 8 hr

Study Arms (3)

CHG 1 min

EXPERIMENTAL

1 min application time

Drug: CHG

CHG 2 min

EXPERIMENTAL

2 min application time

Drug: CHG

Comparator CHG

ACTIVE COMPARATOR

Marketed CHG

Drug: CHG

Interventions

CHGDRUG

Varied application times

Also known as: Chlorhexidine Gluconate
CHG 1 minCHG 2 minComparator CHG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy
  • No dermatological conditions

You may not qualify if:

  • Sensitivity to CHG
  • Sensitivity to natural latex rubber or adhesive skin products

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

chlorhexidine gluconate

Limitations and Caveats

Small sample size.

Results Point of Contact

Title
C. Beausoleil
Organization
BSL
cbeausoleil@biosciencelabs.com
406-587-5735

Study Officials

  • Esther Campbell

    Bioscience Labs

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 16, 2015

First Posted

August 21, 2015

Study Start

April 1, 2014

Primary Completion

July 1, 2014

Study Completion

May 1, 2015

Last Updated

April 30, 2021

Results First Posted

April 30, 2021

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will share

Data to be shared with FDA