An interventional study of 6660 and 4314 in Wound Healing, sponsored by Johnson & Johnson Consumer Products Company Division of Johnson & Johnson Consumer Companies, Inc.. Completed at 1 site in United States. Open to participants aged 30 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-08-04.
Sponsored by Johnson & Johnson Consumer Products Company Division of Johnson & Johnson Consumer Companies, Inc. · Not applicable and Interventional
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.
Exclusion Criteria:
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
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
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
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
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.
At each daily visit, designated study personnel will replace the specific test product on the assigned wound site.
Also known as: Sheer Strips, BAND-AID® with QuiltVent™ Pad Technology
At each daily visit, designated study personnel will replace the specific test product on the assigned wound site.
Also known as: Flexible Fabric, BAND-AID® with QuiltVent™ Pad Technology
At each daily visit, designated study personnel will replace the specific test product on the assigned wound site.
Also known as: Tough Strips® Waterproof, BAND-AID® with QuiltVent™ Pad Technology
At each daily visit, designated study personnel will replace the specific test product on the assigned wound site.
Also known as: Flat Pad, BAND-AID® Dora the Explorer™
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
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
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
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
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
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
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
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
One additional subject was enrolled but withdrew before randomization.
| Milestone | 4 Commercially-available Bandage and 1 Control |
|---|---|
| Started | 46 |
| Randomization | 45 |
| Completed | 40 |
| Not completed | 6 |
| Withdrew: Withdrawal by subject | 4 |
| Withdrew: Lost to follow-up | 1 |
| Withdrew: Administrative decision made by the pi | 1 |
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.
| days | Bandage QuiltVent™ Sheer Strips (With Pad Removed) | Bandage QuiltVent™ Sheer Strips | Bandage QuiltVent™ Flexible Fabric | Bandage QuiltVent™ Tough Strips Waterproof | Bandage Dora the Explorer™ |
|---|---|---|---|---|---|
| Time to Healing (Days) | 13.1 (12.95 to 13.14) | NA (NA to NA) | 13.1 (13.05 to 13.15) | NA (10.90 to NA) | NA (NA to NA) |
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.
| scores on a scale | Bandage QuiltVent™ Sheer Strips (With Pad Removed) | Bandage QuiltVent™ Sheer Strips | Bandage QuiltVent™ Flexible Fabric | Bandage QuiltVent™ Tough Strips Waterproof | Bandage Dora the Explorer™ |
|---|---|---|---|---|---|
| Forced Rank Score | 1.48 ± 0.58 | 3.04 ± 0.90 | 2.44 ± 0.95 | 3.77 ± 1.01 | 3.29 ± 0.95 |
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.
| scores on a scale | Bandage QuiltVent™ Sheer Strips (With Pad Removed) | Bandage QuiltVent™ Sheer Strips | Bandage QuiltVent™ Flexible Fabric | Bandage QuiltVent™ Tough Strips Waterproof | Bandage Dora the Explorer™ |
|---|---|---|---|---|---|
| Erythema | 1.74 ± 0.64 | 0.90 ± 0.42 | 0.90 ± 0.49 | 0.97 ± 0.48 | 0.88 ± 0.43 |
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.
| scores on a scale | Bandage QuiltVent™ Sheer Strips (With Pad Removed) | Bandage QuiltVent™ Sheer Strips | Bandage QuiltVent™ Flexible Fabric | Bandage QuiltVent™ Tough Strips Waterproof | Bandage Dora the Explorer™ |
|---|---|---|---|---|---|
| Edema | 1.44 ± 0.52 | 0.57 ± 0.38 | 0.69 ± 0.43 | 0.56 ± 0.42 | 0.64 ± 0.39 |
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.
| percentage of maceration | Bandage QuiltVent™ Sheer Strips (With Pad Removed) | Bandage QuiltVent™ Sheer Strips | Bandage QuiltVent™ Flexible Fabric | Bandage QuiltVent™ Tough Strips Waterproof | Bandage Dora the Explorer™ |
|---|---|---|---|---|---|
| Maceration | 4.37 ± 9.15 | 70.98 ± 22.12 | 65.21 ± 23.43 | 39.34 ± 31.88 | 63.99 ± 26.64 |
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.
| percentage of pain | Bandage QuiltVent™ Sheer Strips (With Pad Removed) | Bandage QuiltVent™ Sheer Strips | Bandage QuiltVent™ Flexible Fabric | Bandage QuiltVent™ Tough Strips Waterproof | Bandage Dora the Explorer™ |
|---|---|---|---|---|---|
| Subjective Assessment of Pain | 5.24 ± 12.39 | 4.55 ± 10.13 | 2.45 ± 6.38 | 3.85 ± 7.87 | 2.45 ± 5.69 |
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.
| percentage of itching | Bandage QuiltVent™ Sheer Strips (With Pad Removed) | Bandage QuiltVent™ Sheer Strips | Bandage QuiltVent™ Flexible Fabric | Bandage QuiltVent™ Tough Strips Waterproof | Bandage Dora the Explorer™ |
|---|---|---|---|---|---|
| Subjective Assessment of Itch | 21.33 ± 28.24 | 26.22 ± 29.46 | 16.43 ± 21.73 | 25.87 ± 26.24 | 20.10 ± 22.15 |
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.
| Participants | Bandage QuiltVent™ Sheer Strips (With Pad Removed) | Bandage QuiltVent™ Sheer Strips | Bandage QuiltVent™ Flexible Fabric | Bandage QuiltVent™ Tough Strips Waterproof | Bandage Dora the Explorer™ |
|---|---|---|---|---|---|
| Subjective Assessment of Wound Healing | 22 | 20 | 14 | 30 | 26 |
Collected over 30 days and beyond for serious adverse events if assessed as possibly treatment related. Visits 2-15 and beyond if needed for adverse events.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| 4 Commercially-available Bandage and 1 Control | — | 1/46 (2.2%) | 11/46 (23.9%) |
| Event | 4 Commercially-available Bandage and 1 Control |
|---|---|
| BronchopneumoniaInfections and infestations | 1/46 |
| Event | 4 Commercially-available Bandage and 1 Control |
|---|---|
| HeadacheNervous system disorders | 6/46 |
| ExcoriationInjury, poisoning and procedural complications | 1/46 |
| LacerationInjury, poisoning and procedural complications | 1/46 |
| Ligament SprainInjury, poisoning and procedural complications | 1/46 |
| DysphoniaRespiratory, thoracic and mediastinal disorders | 1/46 |
| Respiratory Tract CongestionRespiratory, thoracic and mediastinal disorders | 1/46 |
| Upper Respiratory Tract CongestionRespiratory, thoracic and mediastinal disorders | 1/46 |
| Tooth AbscessInfections and infestations | 1/46 |
| Influenza Like IllnessGeneral disorders | 1/46 |
| Age, Continuous(years) | 4 Commercially-available Bandage and 1 Control |
|---|---|
| Mean | 44.4 ± 7.47 |
| Sex: Female, Male(Participants) | 4 Commercially-available Bandage and 1 Control |
|---|---|
| Female | 24 |
| Male | 21 |
| Race (NIH/OMB)(Participants) | 4 Commercially-available Bandage and 1 Control |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 45 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Ethnicity (NIH/OMB)(Participants) | 4 Commercially-available Bandage and 1 Control |
|---|---|
| Hispanic or Latino | 4 |
| Not Hispanic or Latino | 41 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | 4 Commercially-available Bandage and 1 Control |
|---|---|
| United States | 45 |
| Fitzpatrick Skin Classification(participants) | 4 Commercially-available Bandage and 1 Control |
|---|---|
| Fitzpatrick Skin Classification - II | 11 |
| Fitzpatrick Skin Classification - III | 34 |
This study is completed, as verified in Jul 2014. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Johnson & Johnson Consumer Products Company Division of Johnson & Johnson Consumer Companies, Inc.