Wound Healing
Conditions
Keywords
Adhesive Bandages, Dermabrasion Wounds
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.
Interventions
DEVICE6660
At each daily visit, designated study personnel will replace the specific test product on the assigned wound site.
DEVICE4314
At each daily visit, designated study personnel will replace the specific test product on the assigned wound site.
DEVICE8336
At each daily visit, designated study personnel will replace the specific test product on the assigned wound site.
DEVICE4840
At each daily visit, designated study personnel will replace the specific test product on the assigned wound site.
Sponsors
Johnson & Johnson Consumer Products Company Division of Johnson & Johnson Consumer Companies, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
30 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to Healing (Days) | within 14 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Erythema | within 14 days | 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 | within 14 days | 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 | within 14 days | 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. |
| Forced Rank Score | within 14 days | 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. |
| Subjective Assessment of Itch | within 14 days | 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 | within 14 days | 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. |
| Subjective Assessment of Pain | within 14 days | 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. |
Countries
United States
Participant flow
Recruitment details
One additional subject was enrolled but withdrew before randomization.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 45 |
| Total | 45 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Administrative decision made by the PI | 1 |
| Overall Study | Lost to Follow-up | 1 |
| Overall Study | Withdrawal by Subject | 4 |
Baseline characteristics
| Characteristic | 4 Commercially-available Bandage and 1 Control |
|---|---|
| Age, Continuous | 44.4 years STANDARD_DEVIATION 7.47 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 41 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Fitzpatrick Skin Classification Fitzpatrick Skin Classification - II | 11 participants |
| Fitzpatrick Skin Classification Fitzpatrick Skin Classification - III | 34 participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 45 Participants |
| Region of Enrollment United States | 45 participants |
| Sex: Female, Male Female | 24 Participants |
| Sex: Female, Male Male | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 11 / 46 |
| serious Total, serious adverse events | 1 / 46 |
Outcome results
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.
Time frame: within 14 days
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Bandage QuiltVent™ Sheer Strips (With Pad Removed) | Time to Healing (Days) | 13.1 days |
| Bandage QuiltVent™ Sheer Strips | Time to Healing (Days) | NA days |
| Bandage QuiltVent™ Flexible Fabric | Time to Healing (Days) | 13.1 days |
| Bandage QuiltVent™ Tough Strips Waterproof | Time to Healing (Days) | NA days |
| Bandage Dora the Explorer™ | Time to Healing (Days) | NA 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.
Time frame: within 14 days
Population: The Intent-to-Treat (ITT) population is defined as all subjects who received study bandages. One randomized subject withdrew from the study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bandage QuiltVent™ Sheer Strips (With Pad Removed) | Edema | 1.44 scores on a scale | Standard Deviation 0.52 |
| Bandage QuiltVent™ Sheer Strips | Edema | 0.57 scores on a scale | Standard Deviation 0.38 |
| Bandage QuiltVent™ Flexible Fabric | Edema | 0.69 scores on a scale | Standard Deviation 0.43 |
| Bandage QuiltVent™ Tough Strips Waterproof | Edema | 0.56 scores on a scale | Standard Deviation 0.42 |
| Bandage Dora the Explorer™ | Edema | 0.64 scores on a scale | Standard Deviation 0.39 |
p-value: <0.0001Mixed Models Analysis
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.
Time frame: within 14 days
Population: The Intent-to-Treat (ITT) population is defined as all subjects who received study bandages. One randomized subject withdrew from the study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bandage QuiltVent™ Sheer Strips (With Pad Removed) | Erythema | 1.74 scores on a scale | Standard Deviation 0.64 |
| Bandage QuiltVent™ Sheer Strips | Erythema | 0.90 scores on a scale | Standard Deviation 0.42 |
| Bandage QuiltVent™ Flexible Fabric | Erythema | 0.90 scores on a scale | Standard Deviation 0.49 |
| Bandage QuiltVent™ Tough Strips Waterproof | Erythema | 0.97 scores on a scale | Standard Deviation 0.48 |
| Bandage Dora the Explorer™ | Erythema | 0.88 scores on a scale | Standard Deviation 0.43 |
p-value: <0.0001Mixed Models Analysis
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.
Time frame: within 14 days
Population: The Intent-to-Treat (ITT) population is defined as all subjects who received study bandages. One randomized subject withdrew from the study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bandage QuiltVent™ Sheer Strips (With Pad Removed) | Forced Rank Score | 1.48 scores on a scale | Standard Deviation 0.58 |
| Bandage QuiltVent™ Sheer Strips | Forced Rank Score | 3.04 scores on a scale | Standard Deviation 0.9 |
| Bandage QuiltVent™ Flexible Fabric | Forced Rank Score | 2.44 scores on a scale | Standard Deviation 0.95 |
| Bandage QuiltVent™ Tough Strips Waterproof | Forced Rank Score | 3.77 scores on a scale | Standard Deviation 1.01 |
| Bandage Dora the Explorer™ | Forced Rank Score | 3.29 scores on a scale | Standard Deviation 0.95 |
p-value: <0.0001Mixed Models Analysis
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.
Time frame: within 14 days
Population: The Intent-to-Treat (ITT) population is defined as all subjects who received study bandages. One randomized subject withdrew from the study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bandage QuiltVent™ Sheer Strips (With Pad Removed) | Maceration | 4.37 percentage of maceration | Standard Deviation 9.15 |
| Bandage QuiltVent™ Sheer Strips | Maceration | 70.98 percentage of maceration | Standard Deviation 22.12 |
| Bandage QuiltVent™ Flexible Fabric | Maceration | 65.21 percentage of maceration | Standard Deviation 23.43 |
| Bandage QuiltVent™ Tough Strips Waterproof | Maceration | 39.34 percentage of maceration | Standard Deviation 31.88 |
| Bandage Dora the Explorer™ | Maceration | 63.99 percentage of maceration | Standard Deviation 26.64 |
p-value: <0.0001Mixed Models Analysis
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.
Time frame: within 14 days
Population: The Intent-to-Treat (ITT) population is defined as all subjects who received study bandages. One randomized subject withdrew from the study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bandage QuiltVent™ Sheer Strips (With Pad Removed) | Subjective Assessment of Itch | 21.33 percentage of itching | Standard Deviation 28.24 |
| Bandage QuiltVent™ Sheer Strips | Subjective Assessment of Itch | 26.22 percentage of itching | Standard Deviation 29.46 |
| Bandage QuiltVent™ Flexible Fabric | Subjective Assessment of Itch | 16.43 percentage of itching | Standard Deviation 21.73 |
| Bandage QuiltVent™ Tough Strips Waterproof | Subjective Assessment of Itch | 25.87 percentage of itching | Standard Deviation 26.24 |
| Bandage Dora the Explorer™ | Subjective Assessment of Itch | 20.10 percentage of itching | Standard Deviation 22.15 |
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.
Time frame: within 14 days
Population: The Intent-to-Treat (ITT) population is defined as all subjects who received study bandages. One randomized subject withdrew from the study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bandage QuiltVent™ Sheer Strips (With Pad Removed) | Subjective Assessment of Pain | 5.24 percentage of pain | Standard Deviation 12.39 |
| Bandage QuiltVent™ Sheer Strips | Subjective Assessment of Pain | 4.55 percentage of pain | Standard Deviation 10.13 |
| Bandage QuiltVent™ Flexible Fabric | Subjective Assessment of Pain | 2.45 percentage of pain | Standard Deviation 6.38 |
| Bandage QuiltVent™ Tough Strips Waterproof | Subjective Assessment of Pain | 3.85 percentage of pain | Standard Deviation 7.87 |
| Bandage Dora the Explorer™ | Subjective Assessment of Pain | 2.45 percentage of pain | Standard Deviation 5.69 |
p-value: 0.0476Mixed Models Analysis
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.
Time frame: within 14 days
Population: The Intent-to-Treat (ITT) population is defined as all subjects who received study bandages. One randomized subject withdrew from the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bandage QuiltVent™ Sheer Strips (With Pad Removed) | Subjective Assessment of Wound Healing | 22 Participants |
| Bandage QuiltVent™ Sheer Strips | Subjective Assessment of Wound Healing | 20 Participants |
| Bandage QuiltVent™ Flexible Fabric | Subjective Assessment of Wound Healing | 14 Participants |
| Bandage QuiltVent™ Tough Strips Waterproof | Subjective Assessment of Wound Healing | 30 Participants |
| Bandage Dora the Explorer™ | Subjective Assessment of Wound Healing | 26 Participants |