A Test of Different Kinds of Bandages on Healing of Wounds

Study Overview
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Brief Summary
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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
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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.

Official Title
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An Assessment of QuiltVent™ Pad Technology on the Healing of Induced Dermabrasion Wounds

Conditions
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Wound Healing

Intervention / Treatment
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* Device: 6660
* Device: 4314
* Device: 8336
* Device: 4840


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 6660<br>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<br>* At each daily visit, designated study personnel will replace the specific test product on the assigned wound site.<br>* Other names: BAND-AID® with QuiltVent™ Pad Technology;|
| Active Comparator: 4314<br>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<br>* At each daily visit, designated study personnel will replace the specific test product on the assigned wound site.<br>* Other names: BAND-AID® with QuiltVent™ Pad Technology;|
| Active Comparator: 8336<br>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<br>* At each daily visit, designated study personnel will replace the specific test product on the assigned wound site.<br>* Other names: BAND-AID® with QuiltVent™ Pad Technology;|
| Placebo Comparator: 4840<br>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<br>* At each daily visit, designated study personnel will replace the specific test product on the assigned wound site.<br>* Other names: BAND-AID® Dora the Explorer™;|
| No Intervention: 0000<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Healing (Days) | 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. | within 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Forced Rank Score | 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. | within 14 days | 
| Erythema | 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. | within 14 days | 
| Edema | 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. | within 14 days | 
| Maceration | 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. | within 14 days | 
| Subjective Assessment of Pain | 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. | within 14 days | 
| Subjective Assessment of Itch | 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. | within 14 days | 
| Subjective Assessment of Wound Healing | 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. | within 14 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Adhesive Bandages, Dermabrasion Wounds