A Test of Different Kinds of Bandages on Healing of Wounds

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Consumer and Personal Products Worldwide ( Johnson & Johnson Consumer Products Company Division of Johnson & Johnson Consumer Companies, Inc. )
ClinicalTrials.gov Identifier:
NCT01770860
First received: January 16, 2013
Last updated: July 31, 2014
Last verified: July 2014
  Purpose

This two-week study will compare the healing of minor wounds when no bandage is applied against four different types of bandages.

The study investigators will make five small wounds similar to scrapes (about a half-inch square) on the back of subjects who qualify to participate in the trial and have given informed consent. Four of the wounds will be covered by different bandages and one will be left uncovered. Participants will visit the clinic every day for 2 weeks or until all the wounds are healed (whichever comes first). At the clinic, the bandages will be removed, the doctor will score the wounds, a picture will be taken of the wounds and new bandages will be applied.

It is expected that some pain and itching will be experienced, because they are part of the normal wound healing process. Subjects will be asked about adverse events at each visit and will have the opportunity to discuss issues or concerns with the investigator or the doctor during the course of the trial. It is expected that the wounds will be completely healed within 14 days, but if not, the participant will need to return to the clinic for follow-up treatment until the wounds are completely healed.

We will see if the different bandages help with the healing of the wounds during the study.


Condition Intervention
Wound Healing
Device: 6660
Device: 4314
Device: 8336
Device: 4840

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Official Title: An Assessment of QuiltVent™ Pad Technology on the Healing of Induced Dermabrasion Wounds

Resource links provided by NLM:


Further study details as provided by Johnson & Johnson Consumer and Personal Products Worldwide:

Primary Outcome Measures:
  • Time to Healing (Days) [ Time Frame: within 14 days ] [ Designated as safety issue: No ]
    Wound epithelialization will be recorded daily for each wound (until healed) by the doctor on a scale of 0-5, where 0= No presence of epithelialization (no sign of healing), a bandage is necessary and 5=Wound is 100% epithelialized (healed), no bandage necessary. The median time to healing will be estimated from the survival curves using the Kaplan-Meier method for each test product. Time to healing is defined as the time from wounding to 12:00 pm of the day the wound is 100% epithelialized (receives a score of 5). If the wound is not 100% epithelialized on Day 14 or on the last day of visit, Time to healing will be considered as censored.


Secondary Outcome Measures:
  • Forced Rank Score [ Time Frame: within 14 days ] [ Designated as safety issue: No ]
    The wound evaluator will rank the overall appearance of all five wounds in relation to each other on a daily basis until all five are healed on a scale of 1 to 5, where 1= Worst and 5=Best. The forced Rank was evaluated at each visit. The mean score derived as total score divided by visit number 13 was analyzed using a mixed model.

  • Erythema [ Time Frame: within 14 days ] [ Designated as safety issue: No ]
    Until healed, erythema (redness) of each wound bed and surrounding skin will be scored daily on a scale of 0-10, where 0=None and 10=Most severe. Erythema was evaluated at each visit. The mean score derived as total score divided by visit number 13 was analyzed here using a mixed model.

  • Edema [ Time Frame: within 14 days ] [ Designated as safety issue: No ]
    Until healed, edema (swelling) of each wound bed and surrounding skin will be scored daily on a scale of 0-10, where 0=None and 10=Most severe. Mean Edema was evaluated at each visit. The mean score derived as total score divided by visit number 13 was analyzed using a mixed model.

  • Maceration [ Time Frame: within 14 days ] [ Designated as safety issue: No ]
    Until healed, maceration (a slight whitening of the skin around the wound compared to the surrounding unbandaged area) will be scored as P=Present or A=Absent. Percentage of maceration was derived as the maceration presence times over study period divided by visit number 13.

  • Subjective Assessment of Pain [ Time Frame: within 14 days ] [ Designated as safety issue: No ]
    Until healed, pain assessments by the participant will be recorded daily for each wound site as either Present (P) or Absent (A). Percentage of pain was derived as the pain presence times over study period divided by visit number 13.

  • Subjective Assessment of Itch [ Time Frame: within 14 days ] [ Designated as safety issue: No ]
    Until healed, itch assessments by the participant will be recorded daily for each wound site as either Present (P) or Absent (A). Percentage of itch was derived as the itch presence times over study period divided by visit number 13.

  • Subjective Assessment of Wound Healing [ Time Frame: within 14 days ] [ Designated as safety issue: No ]
    Until healed, subjects will be shown photographs of each wound they have not previously classified as healed at each daily visit, and asked to determine if the wound is healed. Yes or No responses will be recorded, along with text entries of the reasons for the response. This outcome measure reports the number of subjects who report that the wound has healed.


Enrollment: 46
Study Start Date: January 2013
Study Completion Date: February 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 6660
Five dermabrasion wounds will be created on each subject's back by a licensed physician. Four of the wounds will be covered with four different commercially-available bandages (6660, 4314, 8336 and 4840), and one wound will be left open to the air to serve as a no treatment control (0000). Treatments and control will be randomized to application site.
Device: 6660
At each daily visit, designated study personnel will replace the specific test product on the assigned wound site.
Other Names:
  • Sheer Strips
  • BAND-AID® with QuiltVent™ Pad Technology
Active Comparator: 4314
Five dermabrasion wounds will be created on each subject's back by a licensed physician. Four of the wounds will be covered with four different commercially-available bandages (6660, 4314, 8336 and 4840), and one wound will be left open to the air to serve as a no treatment control (0000). Treatments and control will be randomized to application site.
Device: 4314
At each daily visit, designated study personnel will replace the specific test product on the assigned wound site.
Other Names:
  • Flexible Fabric
  • BAND-AID® with QuiltVent™ Pad Technology
Active Comparator: 8336
Five dermabrasion wounds will be created on each subject's back by a licensed physician. Four of the wounds will be covered with four different commercially-available bandages (6660, 4314, 8336 and 4840), and one wound will be left open to the air to serve as a no treatment control (0000). Treatments and control will be randomized to application site.
Device: 8336
At each daily visit, designated study personnel will replace the specific test product on the assigned wound site.
Other Names:
  • Tough Strips® Waterproof
  • BAND-AID® with QuiltVent™ Pad Technology
Placebo Comparator: 4840
Five dermabrasion wounds will be created on each subject's back by a licensed physician. Four of the wounds will be covered with four different commercially-available bandages (6660, 4314, 8336 and 4840), and one wound will be left open to the air to serve as a no treatment control (0000). Treatments and control will be randomized to application site.
Device: 4840
At each daily visit, designated study personnel will replace the specific test product on the assigned wound site.
Other Names:
  • Flat Pad
  • BAND-AID® Dora the Explorer™
No Intervention: 0000

Device: 0000

At each daily visit, designated study personnel will cut out the center pad of the bandage and apply only the adhesive tabs around the assigned wound site.

Other Names:

  • Sheer Strips
  • BAND-AID® with QuiltVent™ Pad Technology

Five dermabrasion wounds will be created on each subject's back by a licensed physician. Four of the wounds will be covered with four different commercially-available bandages (6660, 4314, 8336 and 4840), and one wound will be left open to the air to serve as a no treatment control (0000). Treatments and control will be randomized to application site.


Detailed Description:

This study is evaluating the performance of various bandages on facilitating the healing of induced dermabrasion wounds. To qualify for this study, subjects must meet the inclusion/exclusion criteria within the protocol-specified parameters at both the screening and baseline visits. Once a subject is qualified, five dermabrasion wounds will be created on each subject's back by a licensed physician. Four of the wounds will be covered with four different commercially-available bandages and one wound will be left open to the air to serve as a no treatment control. Treatments and control will be randomized to application site. During this 14-day clinical study, subjects will return to the site for daily evaluations; study bandages will also be replaced daily by study personnel. Adverse events will be observed and collected by querying each subject at each visit, and during any follow-up period.

  Eligibility

Ages Eligible for Study:   30 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subjects must be able to read and understand English enough to understand the nature, risk and relevance of the study, read and sign the informed consent document, and follow study instructions
  • After being completely informed about the study and being given a chance to have all questions answered, the subject has signed an informed consent document agreeing to:
  • comply with lifestyle instructions, including: limiting bandage exposure to water or sunlight, the use of lotions, creams, cosmetics or sunscreens during the study, to allow at least 2 hours between showers and scheduled visits, and the use of contraception
  • return to the clinical site for follow-up visits if the wounds are not healed by Day 14
  • Subject is determined to be an appropriate participant according to protocol-defined conditions, including among other things, Body Weight and Fitzpatrick Skin Type between I (Always burns easily, never tans) and III (Burns moderately, tans gradually)
  • In the opinion of the Investigator, participation in the trial will not compromise the subject's safety or the interpretation of study results

Exclusion Criteria:

  • Medical condition or history, or use of drugs or treatments that could possibly compromise the safety of the research subject or the interpretation of results, per protocol or in the opinion of the investigator
  • Known allergies or hypersensitivity to LATEX, anesthetics, adhesive bandages, wound treatment products or any component present in the test bandages
  • Current participation in any other clinical trial or past participation in other clinical trials described in the protocol
  • Body mass index (BMI) above 35, and/or Fitzpatrick Skin Type above III
  • Pregnant, nursing or planning a pregnancy
  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: NCT01770860

Locations
United States, Florida
Hill Top Research
St. Petersburg, Florida, United States, 33710
Sponsors and Collaborators
Johnson & Johnson Consumer Products Company Division of Johnson & Johnson Consumer Companies, Inc.
Investigators
Study Director: Clare Kendall Johnson & Johnson Consumer Products Company Division of Johnson & Johnson Consumer Companies, Inc.
  More Information

No publications provided

Responsible Party: Johnson & Johnson Consumer and Personal Products Worldwide ( Johnson & Johnson Consumer Products Company Division of Johnson & Johnson Consumer Companies, Inc. )
ClinicalTrials.gov Identifier: NCT01770860     History of Changes
Other Study ID Numbers: ABDWDP0005
Study First Received: January 16, 2013
Results First Received: May 13, 2014
Last Updated: July 31, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Johnson & Johnson Consumer and Personal Products Worldwide:
Adhesive Bandages
Dermabrasion Wounds

ClinicalTrials.gov processed this record on September 22, 2014