NCT02530528

Brief Summary

Pilot study to evaluate and compare activity of investigational preoperative preparation (2% CHG) with comparator (2% CHG).

Trial Health

100
On Track

Trial Health Score

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

Enrollment
27

participants targeted

Target at P25-P50 for phase_1 surgery

Timeline
Completed

Started Feb 2014

Shorter than P25 for phase_1 surgery

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

February 1, 2014

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
1.4 years 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

2 months

First QC Date

August 16, 2015

Results QC Date

February 2, 2016

Last Update Submit

April 28, 2021

Conditions

Surgery

Keywords

Surgical Skin Preparation

Outcome Measures

Primary Outcomes (1)

  • Log Reduction of Bacterial Flora on Abdomen and Groin Sites

    Evaluate the Log Reduction of Normal Flora at various sites and timepoints

    10 min, 6 hr and 8 hr

Study Arms (4)

2% CHG 1 min

EXPERIMENTAL

single administration, 1 min application time

Drug: CHG

2% CHG 2 min

EXPERIMENTAL

single administration, 2 min application time

Drug: CHG

2% CHG 3 min

EXPERIMENTAL

single administration, 3 min application time

Drug: CHG

Comparator 2% CHG

ACTIVE COMPARATOR

Single administration, Marketed CHG

Drug: CHG

Interventions

CHGDRUG

Varied application times

Also known as: Chlorhexidine Gluconate
2% CHG 1 min2% CHG 2 min2% CHG 3 minComparator 2% CHG

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (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

Results Point of Contact

Title
Dr. MH Bashir
Organization
MicroBioTest
muhammad.bashir@microbac.com
7039250100

Study Officials

  • Bashir M Hamid, MD

    Microbac Laboratories

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
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

February 1, 2014

Primary Completion

April 1, 2014

Study Completion

April 1, 2014

Last Updated

April 30, 2021

Results First Posted

April 30, 2021

Record last verified: 2020-09