Human Repeat Insult Patch Test of Wound Dressings

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Covalon Technologies Inc.
ClinicalTrials.gov Identifier:
NCT01368146
First received: June 6, 2011
Last updated: April 15, 2015
Last verified: April 2015
  Purpose

The purpose of this study is to determine whether contact sensitization occurs to the skin of normal healthy human subjects, by repetitive application of IV Clear™, Tegaderm CHG™ and Silicone Vehicle Control dressings.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label

Further study details as provided by Covalon Technologies Inc.:

Primary Outcome Measures:
  • Irritation [ Time Frame: Assessed at induction phase (evaluated before reapplication; 9 applications over 3 weeks, reapplied after every 48 or 72 hrs) and challenge phase (single 48-hr application of test article to naive sites and evaluation 30 mins, 24 and 48 hrs post-removal ] [ Designated as safety issue: No ]
    Irritation assessed at the induction phase will be scored on a Berger and Bowman Scale. Irritation assessed at the challenge phase will be scored on a defined scale measuring erythema reactions, ranging from no reaction to strong erythema.


Secondary Outcome Measures:
  • Adhesion [ Time Frame: Assessed at each 72 hour evaluation over three weeks, and once for a single 48-hour challenge application ] [ Designated as safety issue: No ]

    Adhesion was scored as follows:

    0 = no lift from skin (≥90% adherence)

    1. = some edges only lifting from skin (≥75% to ˂90% adherence)
    2. = less than half of the test article lifing (≥50% to ˂75% adherence)
    3. = more than half of the test article lifing but not detached (≥25% to ˂50% adherence)
    4. = test article detached (0% adherence)

  • Pain upon removal [ Time Frame: Assessed by subjects at 72 hour evaluations over three weeks and a single 48-hour challenge application ] [ Designated as safety issue: Yes ]
    Any pain experienced during removal will be rated on a scale from 0 to 10, where 0 = no pain and 10 = worst possible pain.


Enrollment: 216
Study Start Date: March 2011
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: IV Clear™ Device: IV Clear™
Polyurethane film with a silicone adhesive dressing containing chlorhexidine and silver
Active Comparator: Tegaderm CHG™ Device: Tegaderm CHG™
Polyurethane film with a polyacrylate adhesive and a polyol hydrogel containing 2% w/w chlorhexidine gluconate
Placebo Comparator: Control Vehicle 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. Qualified subjects will complete three phases of the study (induction, rest and challenge).

Data for irritation, adhesion and pain upon removal will be collected from the individual patch sites.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male or female, 18 years or older
  • In good health, as determined by medical history and concomitant medication
  • Able to comprehend and sign informed consent
  • Unable to bear children or willing to use adequate birth control
  • Willing and able to follow study directions, to participate in the study and to return for all specific visit

Exclusion Criteria:

  • Subject pregnant, planning a pregnancy or lactating
  • Diabetes (any type)
  • Mastectomy involving removal of lymph nodes
  • Clinically significant skin disease, including but not limited to psoriasis, eczema, atopic dermatitis, and active cancer
  • Asthma or other severe respiratory disease requiring medication
  • Self-reported immunological disorders including (but not limited to) HIV positive, AIDS, rheumatoid arthritis, and systematic lupus erythematosus
  • Treatment of any type of cancer within the last two years or history of skin cancer in the test area
  • Use of any of the following: topically applied products (e.g. medicals, lotions, creams, etc.) at the application site within 3 days of first application of test articles, immunosuppressive drugs within 30 days of first application of test articles, systemic or topical corticosteroids within 30 days of first application of test articles, and systemic or topically applied anti-inflammatory and antihistamine medications within 3 days of first application of test articles
  • Participation in any patch test for irritation or sensitization within the last four weeks
  • Participation in any investigational drug study within the last four weeks
  • Damaged skin in or around the test sites which includes: sunburn, extremely deep tans, uneven skin tones, tattoos, scars, excessive hair, numerous freckles, or other disfiguration
  • Known sensitization to adhesives, bandages, or materials used in test articles
  • Medical condition which, in investigator's judgment, makes the subject ineligible or places the subject at undue risk
  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: NCT01368146

Locations
United States, Florida
Hill Top Research
St. Petersburg, Florida, United States, 33710
Sponsors and Collaborators
Covalon Technologies Inc.
Investigators
Principal Investigator: Micah Humphrey, B.S. Hill Top Research
  More Information

No publications provided

Responsible Party: Covalon Technologies Inc.
ClinicalTrials.gov Identifier: NCT01368146     History of Changes
Other Study ID Numbers: TP-015
Study First Received: June 6, 2011
Last Updated: April 15, 2015
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on July 01, 2015