Clinical trial NCT01770860: A Test of Different Kinds of Bandages on Healing of Wounds
Official title: An Assessment of QuiltVent™ Pad Technology on the Healing of Induced Dermabrasion Wounds
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Wound Healing
Keywords: Adhesive Bandages
Dermabrasion Wounds
Lead sponsor: Johnson & Johnson Consumer and Personal Products Worldwide
Sponsor class: INDUSTRY
First posted: 2013-01-18
Enrollment: 46
Sex: ALL
Minimum age (years): 30
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: 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.

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 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

Primary outcomes:
measure: Time to Healing (Days)
timeFrame: within 14 days
Secondary outcomes:
measure: Forced Rank Score
timeFrame: within 14 days
measure: Erythema
timeFrame: within 14 days
measure: Edema
timeFrame: within 14 days
measure: Maceration
timeFrame: within 14 days
measure: Subjective Assessment of Pain
timeFrame: within 14 days
measure: Subjective Assessment of Itch
timeFrame: within 14 days
measure: Subjective Assessment of Wound Healing
timeFrame: within 14 days
Other outcomes:
Locations:
city: St. Petersburg
country: United States
facility: Hill Top Research
state: Florida
Study officials:
affiliation: Johnson & Johnson Consumer Products Company Division of Johnson & Johnson Consumer Companies, Inc.
name: Clare Kendall
role: STUDY_DIRECTOR
References: