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| ID | Type | Description | Link |
|---|---|---|---|
| CCSTOH003808 | Other Identifier | Johnson & Johnson Consumer Inc. (J&JCI) |
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The purpose of this study is to evaluate the healing rates of wounds treated with various wound care regimens including antiseptic wound wash, topical antibiotic treatment, adhesive bandages, and/or hydrocolloid bandages.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment A: Uncovered Wound (Negative Control) | No Intervention | Minor wounds will be created on participant's forearms (four per arm) by a certified laser specialist. On the randomized wound site, no treatment will be applied as the wound will be kept uncovered as a negative control. | |
| Treatment B: Standard of Care (SoC) Adhesive Bandage | Active Comparator | Minor wounds will be created on participant's forearms (four per arm) by a certified laser specialist. On the randomized wound site, SoC adhesive bandage will be applied. This treatment will be changed daily from Day 1 through Day 6 and all wound sites will be uncovered from Day 7 to Day 16 for assessments. |
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| Treatment C: Antibiotic Ointment | Experimental | Minor wounds will be created on participant's forearms (four per arm) by a certified laser specialist. On the randomized wound site, antibiotic ointment will be applied. This treatment will be applied daily from Day 1 through Day 6 and all wound sites will be uncovered from Day 7 to Day 16 for assessments. |
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| Treatment D: Antibiotic Ointment Plus SoC Adhesive Bandage | Experimental | Minor wounds will be created on participant's forearms (four per arm) by a certified laser specialist. On the randomized wound site, antibiotic ointment plus SoC adhesive bandage will be applied. This treatment will be applied and changed daily from Day 1 through Day 6 and all wound sites will be uncovered from Day 7 to Day 16 for assessments. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SoC Adhesive Bandage | Device | On the randomized wound site, a SoC adhesive bandage will be applied. |
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| Measure | Description | Time Frame |
|---|---|---|
| Composite Healing Score | Composite healing score will be calculated from clinical grading of wound healing parameters as (general wound appearance score plus [+] smoothness score + epithelial confluence score) minus [-] (erythema score + edema score + crusting/scabbing score). Composite healing score on a 25-point scale (-12 [no healing] to +12 [towards healing]) is indicative of extent of wound healing and will be calculated for each wound site at each evaluation day. | Day 0 through Day 7 |
| Composite Healing Score | Composite healing score will be calculated from clinical grading of wound healing parameters as (general wound appearance score + smoothness score + epithelial confluence score) - (erythema score + edema score + crusting/scabbing score). Composite healing score on a 25-point scale (-12 [no healing] to +12 [towards healing]) is indicative of extent of wound healing and will be calculated for each wound site at each evaluation day. | Day 16 |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Grading of Wound Healing of Erythema | Clinical grading of wound healing of erythema will be reported. It will be evaluated on a scale of 0 to 4 with 0=none/absent, 1=mild, 2=moderate, 3=marked, and 4=severe, with higher scores indicating a worse outcome. | Day 0 through Day 7, Day 16 |
| Clinical Grading of Wound Healing of Edema |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tanja Emmerich, Ph.D. | SGS Stephens, Inc. Dallas Research Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SGS Stephens, Inc. Dallas Research Center | Richardson | Texas | 75081 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 7808826 | Background | Mancini AJ, Sookdeo-Drost S, Madison KC, Smoller BR, Lane AT. Semipermeable dressings improve epidermal barrier function in premature infants. Pediatr Res. 1994 Sep;36(3):306-14. doi: 10.1203/00006450-199409000-00007. | |
| 14007593 | Background | WINTER GD. Formation of the scab and the rate of epithelization of superficial wounds in the skin of the young domestic pig. Nature. 1962 Jan 20;193:293-4. doi: 10.1038/193293a0. No abstract available. |
| Label | URL |
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| Related Info | View source |
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Johnson & Johnson Consumer Inc. has an agreement with the Yale Open Data Access (YODA) Project to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu.
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| Treatment E: Antiseptic Wash Plus Antibiotic Ointment Plus SoC Adhesive Bandage | Experimental | Minor wounds will be created on participant's forearms (four per arm) by a certified laser specialist. On the randomized wound site, antiseptic wash plus antibiotic ointment plus SoC adhesive bandage will be applied. This treatment will be applied and changed daily from Day 0 through Day 2 and all wound sites will be uncovered after Day 3 to Day 16 for assessments. |
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| Treatment F: Antiseptic Wash Plus Antibiotic Ointment Plus SoC Adhesive Bandage | Experimental | Minor wounds will be created on participant's forearms (four per arm) by a certified laser specialist. On the randomized wound site, antiseptic wash plus antibiotic ointment plus SoC adhesive bandage will be applied. This treatment will be applied and changed daily from Day 1 through Day 6 and all wound sites will be uncovered from Day 7 to Day 16 for assessments. |
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| Treatment G: Hydrocolloid Pad | Experimental | Minor wounds will be created on participant's forearms (four per arm) by a certified laser specialist. On the randomized wound site, hydrocolloid pad will be applied. This treatment will be changed daily from Day 1 through Day 6 and all wound sites will be uncovered from Day 7 to Day 16 for assessments. |
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| Treatment H: Hydrocolloid Pad | Experimental | Minor wounds will be created on participant's forearms (four per arm) by a certified laser specialist. On the randomized wound site, hydrocolloid pad will be applied. This treatment will be changed daily from Day 1 through Day 6 and all wound sites will be uncovered from Day 7 to Day 16 for assessments. |
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| Antibiotic Ointment | Drug | On the randomized wound site, a antibiotic ointment will be applied. |
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| Antiseptic Wash | Drug | On the randomized wound site, a antiseptic wash will be applied. |
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| Hydrocolloid Pad | Device | On the randomized wound site, hydrocolloid pad will be applied. |
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Clinical grading of wound healing of edema will be reported. It will be evaluated on a scale of 0 to 4 with 0=none/absent, 1=mild, 2=moderate, 3=marked, and 4=severe, with higher scores indicating a worse outcome. |
| Day 0 through Day 7, Day 16 |
| Clinical Grading of Wound Healing of General Wound Appearance | Clinical grading of wound healing of general wound appearance will be reported. It is evaluated on a scale from 0 to 4 with 0=poor, 1=fair, 2=good, 3=very good, 4=excellent with higher scores indicating a better outcome. | Day 0 through Day 7, Day 16 |
| Clinical Grading of Wound Healing of Smoothness | Clinical grading of wound healing of smoothness of popped pimple as assessed by trained grader will be reported. It will be evaluated on a scale of 0 to 4 with 0=rough, uneven wound, 1=mild smoothness, 2=moderate smoothness, 3=extensive smoothness, and 4=complete smooth, even wound, with higher scores indicating a better outcome. | Day 0 through Day 7, Day 16 |
| Clinical Grading of Wound Healing of Epithelial Confluence | Clinical grading of wound healing of epithelial confluence will be reported. It will be evaluated on a scale from 0 to 4 with 0=none (no epithelial coverage), 1=slight (up to 30 percent [%]), 2=moderate (31% to 60%), 3=extensive (61% to 90%), and 4=almost complete or complete (91% to 100%, covered with a full layer of new epithelial growth), with higher scores indicating a better outcome. | Day 0 through Day 7, Day 16 |
| Clinical Grading of Wound Healing of Crusting/Scabbing | Clinical grading of wound healing of crusting/scabbing will be reported. It will be evaluated on a scale of 0 to 4 with 0=none, 1=slight (up to 30%), 2=moderate (31% to 60%), 3=extensive (61% to 90%), and 4=almost complete or complete (91% to 100%), with higher scores indicating a worse outcome. | Day 0 through Day 7, Day 16 |
| Wound Healing Process Assessment Score | Wound healing process assessment of each test site will be performed and a score of "0" or "1" will be assigned where 0=primary healing (the wound heals by primary epithelial tissue), and 1=secondary healing (the wound heals through the stage of formation of connective tissue). | Day 16 |
| Painful Score with Arm Resting by Side (Participant's Self-assessment Questionnaire) | Painful score with arm resting by side based on participants self-assessment questionnaire score (question 1) will be reported. Participants will be asked to rate each wound for pain/soreness in resting position as score from 0 (no pain) to 10 (severe pain). | Day 0 through Day 7, Day 16 |
| Pain Duration with Arm Resting by Side (Participant's Self-assessment Questionnaire) | Participants will be asked to rate the pain as either brief, periodic, or constant in arm resting position with the Self-assessment questionnaire (question 2). | Day 0 through Day 7, Day 16 |
| Painful Score with Arm in Normal Motion (Participant's Self-assessment Questionnaire) | Painful Score based on participants self-assessment questionnaire score (question 3) will be reported. Participants will be asked to rate each wound for pain/soreness in normal position as score from 0 (no pain) to 10 (severe pain). | Day 0 through Day 7, Day 16 |
| Pain Duration with Arm in Normal Motion (Participant's Self-assessment Questionnaire) | Participants will be asked to rate the pain as either brief, periodic, or constant in arm normal motion with the Self-Assessment Questionnaire (question 4). | Day 0 through Day 7, Day 16 |
| Itchy Score of Wound Site (Participant's Self-assessment Questionnaire) | Itchy score based on participants self-assessment questionnaire score (question 5) will be reported. Participants will be asked to rate each wound for itchiness as score from 0 (no itch) to 10 (severe itch). | Day 0 through Day 7, Day 16 |
| 16752710 | Background | Winter GD. Some factors affecting skin and wound healing. J Tissue Viability. 2006 May;16(2):20-3. doi: 10.1016/s0965-206x(06)62006-8. |
| Background | Bernard DB. Chapter 41: Minor Burns, Sunburns, and Wounds. In Krinsky DL, Ferreri SP, and Hemstreet B., et al., Handbook of nonprescription drugs: An interactive approach to self-care (19th ed.) Washington, DC: American Pharmacists Association. doi:https://doi-org.jerome.stjohns.edu/10.21019/9781582122656.ch41 |
| Background | Cuts and scrapes: First aid. (2019, October 29). Retrieved January 22, 2021, from https://www.mayoclinic.org/first-aid/first-aid-cuts/basics/art-20056711 |
| 21247665 | Background | Trookman NS, Rizer RL, Weber T. Treatment of minor wounds from dermatologic procedures: a comparison of three topical wound care ointments using a laser wound model. J Am Acad Dermatol. 2011 Mar;64(3 Suppl):S8-15. doi: 10.1016/j.jaad.2010.11.011. Epub 2011 Jan 17. |
| Background | NIH Publication No. 98-4083 (1998, September). Adapted from Clinical Guidelines on the Identification, Evaluation, and Treatment of Overweight and Obesity in Adults: The Evidence Report. Retrieved from URL. https://www.nhlbi.nih.gov/health/educational/lose_wt/BMI/bmi_tbl.htm. 22 May 2019. |