NCT01368120

CompletedPhase 1

Antimicrobial Activity of IV Clear™ Dressing - Prevention of...

Covalon Technologies Inc.Source

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Other study identifiers

Sponsor study identifier

TP-014

Study Type

interventional

Actual enrollment (reported)

37

Locations

1 country

Sites

1

Timeline

Study Start

April 2011

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

July 2011

Actual (reported)

Study Completion

July 2011

Actual (reported)

Brief Summary

The purpose of this study is to assess the surface cutaneous antimicrobial activity of IV Clear™ Dressing, Tegaderm CHG™ Dressing and a Silicone Vehicle Control Dressing.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 37 participants
Study completion date: July 2011
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
April 2011
Date type not reported
This date has not been verified as actual or estimated.
First Submitted
June 6, 2011
Actual (reported)
First Posted
June 7, 2011
Actual (reported)
Primary Completion
July 2011
Actual (reported)
Study Completion
July 2011
Actual (reported)

Last Updated: April 16, 2015
Status Verified: April 2015
Last Update Submitted: April 15, 2015

Conditions

Skin Flora Infection

Outcome Measures

Primary Outcomes (1)

Change in skin microbial colonization over 7-day period of antimicrobial dressing application
Mean number of Colony Forming Units (CFUs) per square centimetre (cm²) of skin prior to treatment (baseline), following prepping with 70% isopropyl alcohol and following post treatment samplings of IV Clear™, Tegaderm™ CHG and Silicone control dressings collected.
Assessed after 4 days and 7 days of dressing application

Study Arms (3)

IV Clear™

EXPERIMENTAL

Device: IV Clear™ Dressing

Tegaderm CHG™

ACTIVE COMPARATOR

Device: Tegaderm CHG™

Vehicle Control Dressing

PLACEBO COMPARATOR

Device: Silicone Vehicle Control Dressing

Interventions

IV Clear™ DressingDevice

Polyurethane film, silicone adhesive dressing with chlorhexidine and silver

IV Clear™

Tegaderm CHG™Device

Polyurethane film, polyacrylate adhesive and a polyol hydrogel containing 2% w/w chlorhexidine gluconate

Tegaderm CHG™

Eligibility Criteria

Age18 Years - 65 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Are ≥ 18 years of age and ≤ 65 years of age
Are in good health, as evidenced by response to the demographics/dermatological medical history form

Sponsors & Collaborators

Covalon Technologies Inc.
Industrylead

Study Sites (1)

Hill Top Research

Miamiville, Ohio, 45147, United States

Study Officials

Dennis J Ward, D.O.
Hill Top Research
PRINCIPAL INVESTIGATOR

Enrollment

37 participants (actual enrollment reported by the registry).

Study Design

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

Study Record Dates

First Submitted

June 6, 2011

First Posted

June 7, 2011

Study Start

April 2011

Date type not reported

This date has not been verified as actual or estimated.

Silicone Vehicle Control DressingDevice

Polyurethane film with silicone adhesive dressing, without antimicrobials

Vehicle Control Dressing

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Are willing to refrain from using antimicrobial soaps for bathing and showering during the entire study

Are willing to refrain from swimming in chemically treated pool or hot tub for duration of study

Are willing to refrain from using antimicrobial/medicated lotions and creams for duration of study, unless prescribed by a physician for an intercurrent illness

Are willing to refrain from using topical or systemic antibiotic medication for duration of study, unless prescribed by a physician for an intercurrent illness

Are willing to refrain from use of body powders and fabric softeners

Are willing to use soap and shampoo and antiperspirant/deodorant provided exclusively during study

Have qualification screening bacterial counts of ≥ 2.5 log10 CFU/cm² on two contralateral sites on the upper back

Are willing to comply with all study protocol requirements

You may not qualify if:

Subjects will not be enrolled in the study if they:
Are currently pregnant or lactating
Have been exposed to topical or systemic antimicrobials during two weeks proceeding treatment. This restriction will include, but is not limited to shampoos, lotions, soaps, body powders, and materials such as solvents, acids, or alkalis
Have known soap, detergent, antibiotic and/or perfume allergies
Have been medically diagnosed as having a medical condition that precludes participation, such as: diabetes, hepatitis, an organ transplant, a medical surgical implant or an immune compromised system
Have any medical condition which in the opinion of the Investigator prelude participation
Have swam in chemically treated pools or hot tubs two weeks prior to any microbial sampling
Have used UV tanning lamps two weeks prior to any microbial sampling
Have tattoos, dermatoses, abrasions, cuts, lesions or other skin disorders on test sites
Have bathed or showered less than 48 hours prior to any microbial sampling
Have known sensitivity to adhesive products, or to materials used in test articles
Have participated in any type of back wash study within 7 days prior to study
Have a known sensitivity to latex products
Are not willing to fulfill the requirements of the protocol

Contact the study team to confirm eligibility.

Primary Completion

July 2011

Actual (reported)

Study Completion

July 2011

Actual (reported)

Last Updated

April 16, 2015

Record last verified: 2015-04

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT01368120
Data provider: ClinicalTrials.gov
Source updated: 2015-04-16
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:35:06 UTC

Locations

US(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Study Arms (3)

IV Clear™

Tegaderm CHG™

Vehicle Control Dressing

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations