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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 6660 | Active Comparator | 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. |
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| 4314 | Active Comparator | 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. |
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| 8336 | Active Comparator | 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. |
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| 4840 | Placebo Comparator | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 6660 | Device | At each daily visit, designated study personnel will replace the specific test product on the assigned wound site. |
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clare Kendall | Johnson & Johnson Consumer Products Company Division of Johnson & Johnson Consumer Companies, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hill Top Research | St. Petersburg | Florida | 33710 | United States |
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One additional subject was enrolled but withdrew before randomization.
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| ID | Title | Description |
|---|---|---|
| FG000 | 4 Commercially-available Bandage and 1 Control | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 4 Commercially-available Bandage and 1 Control | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | The Intent-to-Treat (ITT) population is defined as all subjects who received study bandages. Forty six subjects were enrolled but one withdrew before randomization. | Posted | Median | 95% Confidence Interval | days | within 14 days |
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30 days and beyond for serious adverse events if assessed as possibly treatment related. Visits 2-15 and beyond if needed for adverse events.
The safety population was 46. One subject withdrew from the study, before randomization or receving treatment, due to a serious adverse event.
Adverse events were collected for all five interventions simultaneously without attributing causal relationship to a particular intervention.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 4 Commercially-available Bandage and 1 Control | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bronchopneumonia | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Associate Director, Clinical Research | Johnson & Johnson Consumer Products Company Division of Johnson & Johnson Consumer Companies, Inc. | 973-385-7984 |
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|
| 0000 | No Intervention | 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:
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. |
| 4314 | Device | At each daily visit, designated study personnel will replace the specific test product on the assigned wound site. |
|
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| 8336 | Device | At each daily visit, designated study personnel will replace the specific test product on the assigned wound site. |
|
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| 4840 | Device | At each daily visit, designated study personnel will replace the specific test product on the assigned wound site. |
|
|
| 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 |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Fitzpatrick Skin Classification | The Fitzpatrick skin classification is based on the skin's unprotected response to the first 30-45 minutes of sun exposure after a winter season without sun exposure. The classification is on a scale from I to VI where I = always burns easily; never tans and VI =Never burns; deeply pigmented. | Number | participants |
|
No treatment |
| OG001 | Bandage QuiltVent™ Sheer Strips |
| OG002 | Bandage QuiltVent™ Flexible Fabric |
| OG003 | Bandage QuiltVent™ Tough Strips Waterproof |
| OG004 | Bandage Dora the Explorer™ |
|
|
| Secondary | 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. | The Intent-to-Treat (ITT) population is defined as all subjects who received study bandages. One randomized subject withdrew from the study. | Posted | Mean | Standard Deviation | scores on a scale | within 14 days |
|
|
|
|
| Secondary | 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. | The Intent-to-Treat (ITT) population is defined as all subjects who received study bandages. One randomized subject withdrew from the study. | Posted | Mean | Standard Deviation | scores on a scale | within 14 days |
|
|
|
|
| Secondary | 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. | The Intent-to-Treat (ITT) population is defined as all subjects who received study bandages. One randomized subject withdrew from the study. | Posted | Mean | Standard Deviation | scores on a scale | within 14 days |
|
|
|
|
| Secondary | 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. | The Intent-to-Treat (ITT) population is defined as all subjects who received study bandages. One randomized subject withdrew from the study. | Posted | Mean | Standard Deviation | percentage of maceration | within 14 days |
|
|
|
|
| Secondary | 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. | The Intent-to-Treat (ITT) population is defined as all subjects who received study bandages. One randomized subject withdrew from the study. | Posted | Mean | Standard Deviation | percentage of pain | within 14 days |
|
|
|
|
| Secondary | 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. | The Intent-to-Treat (ITT) population is defined as all subjects who received study bandages. One randomized subject withdrew from the study. | Posted | Mean | Standard Deviation | percentage of itching | within 14 days |
|
|
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| Secondary | 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. | The Intent-to-Treat (ITT) population is defined as all subjects who received study bandages. One randomized subject withdrew from the study. | Posted | Number | Participants | within 14 days |
|
|
|
| 1 |
| 46 |
| 11 |
| 46 |
| Excoriation | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
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| Laceration | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
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| Ligament Sprain | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
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| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
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| Respiratory Tract Congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
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| Upper Respiratory Tract Congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
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| Tooth Abscess | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
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| Influenza Like Illness | General disorders | MedDRA 16.0 | Systematic Assessment |
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