Human Repeat Insult Patch Test of Wound Dressings

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01368146
Recruitment Status : Completed
First Posted : June 7, 2011
Last Update Posted : April 16, 2015
Information provided by (Responsible Party):
Covalon Technologies Inc.

Brief Summary:
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 or disease Intervention/treatment Phase
Skin Sensitization Device: IV Clear™ Device: Tegaderm CHG™ Device: Silicone Vehicle Control Dressing Phase 1

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 216 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Study Start Date : March 2011
Actual Primary Completion Date : April 2011
Actual Study Completion Date : April 2011

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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 ]
    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 :
  1. Adhesion [ Time Frame: Assessed at each 72 hour evaluation over three weeks, and once for a single 48-hour challenge application ]

    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)

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

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01368146

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

Responsible Party: Covalon Technologies Inc. Identifier: NCT01368146     History of Changes
Other Study ID Numbers: TP-015
First Posted: June 7, 2011    Key Record Dates
Last Update Posted: April 16, 2015
Last Verified: April 2015