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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Covalon Technologies Inc.
ClinicalTrials.gov Identifier:
NCT01368120
First received: June 6, 2011
Last updated: April 15, 2015
Last verified: April 2015
  Purpose

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.


Condition Intervention Phase
Skin Flora Infection
Device: IV Clear™ Dressing
Device: Tegaderm CHG™
Device: Silicone Vehicle Control Dressing
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention

Further study details as provided by Covalon Technologies Inc.:

Primary Outcome Measures:
  • Change in skin microbial colonization over 7-day period of antimicrobial dressing application [ Time Frame: Assessed after 4 days and 7 days of dressing application ] [ Designated as safety issue: No ]
    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.


Enrollment: 37
Study Start Date: April 2011
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: IV Clear™ Device: IV Clear™ Dressing
Polyurethane film, silicone adhesive dressing with chlorhexidine and silver
Active Comparator: Tegaderm CHG™ Device: Tegaderm CHG™
Polyurethane film, polyacrylate adhesive and a polyol hydrogel containing 2% w/w chlorhexidine gluconate
Placebo Comparator: Vehicle Control Dressing Device: Silicone Vehicle Control Dressing
Polyurethane film with silicone adhesive dressing, without antimicrobials

Detailed Description:

A single center, within-subject randomized study design in healthy adult subjects with a history of high bacteria counts on their upper back, meeting the inclusion criteria.

Antimicrobial efficacy will be measured by determining the mean number of Colony Forming Units (CFUs) per square centimetre (cm²) of skin prior to treatment (baseline measurement), following preparation with 70% isopropyl alcohol, and following post treatment samples.

The goal of this study is to demonstrate that IV Clear™ is as effective as or better than Tegaderm™ CHG dressing in preventing regrowth of cutaneous microbial flora on test subjects.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01368120

Locations
United States, Ohio
Hill Top Research
Miamiville, Ohio, United States, 45147
Sponsors and Collaborators
Covalon Technologies Inc.
Investigators
Principal Investigator: Dennis J Ward, D.O. Hill Top Research
  More Information

No publications provided

Responsible Party: Covalon Technologies Inc.
ClinicalTrials.gov Identifier: NCT01368120     History of Changes
Other Study ID Numbers: TP-014
Study First Received: June 6, 2011
Last Updated: April 15, 2015
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Anti-Infective Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on September 02, 2015