NCT02530554

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

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

Enrollment
14

participants targeted

Target at below P25 for phase_1 surgery

Timeline
Completed

Started Jul 2015

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

July 1, 2015

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
15 days 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
5.1 years until next milestone

Results Posted

Study results publicly available

September 28, 2020

Completed
Last Updated

September 28, 2020

Status Verified

September 1, 2020

Enrollment Period

1 month

First QC Date

August 16, 2015

Results QC Date

February 3, 2016

Last Update Submit

September 1, 2020

Conditions

Surgery

Keywords

Preoperative surgical skin preparation

Outcome Measures

Primary Outcomes (1)

  • Log Change in Bacterial Flora on Abdomen and Groin

    Change was calculated as the baseline time point minus the later time points over an 8 hour period.

    10 min, 6 hr and 8 hr

Study Arms (2)

CHG Cloth

EXPERIMENTAL

3 min application time

Drug: CHG

Comparator CHG

ACTIVE COMPARATOR

Marketed 2% CHG

Drug: CHG

Interventions

CHGDRUG

Single application

Also known as: Chlorhexidine Gluconate
CHG ClothComparator 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

Results Point of Contact

Title
Dr. R Olsavszky
Organization
Evic Romania
evicromania@evic.ro
40 21 335 70 91

Study Officials

  • R Olsavszky, MD

    S.C. Bio High Tech S.R.L

    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

July 1, 2015

Primary Completion

August 1, 2015

Study Completion

August 1, 2015

Last Updated

September 28, 2020

Results First Posted

September 28, 2020

Record last verified: 2020-09