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

NCT01368120 | Completed Phase 1

• 1 other identifier: TP-014
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

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.

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™ Dressing DEVICE

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™

Silicone Vehicle Control Dressing DEVICE

Polyurethane film with silicone adhesive dressing, without antimicrobials

Vehicle Control Dressing

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (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
• 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

Sponsors & Collaborators

• Covalon Technologies Inc.: lead

Study Sites (1)

Hill Top Research

Miamiville, Ohio, 45147, United States

Location

Study Officials

• Dennis J Ward, D.O.

  Hill Top Research

  PRINCIPAL INVESTIGATOR

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 1, 2011
• Primary Completion: July 1, 2011
• Study Completion: July 1, 2011
• Last Updated: April 16, 2015

Record last verified: 2015-04

Locations

US (1)