SGS Stephens, Inc. Dallas Research Center
Richardson, Texas, 75081, United States
NCT Number: NCT05045183
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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Notify Me25 year–55 year
All sexes
Interventional
Not applicable
Richardson, Texas, 75081, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
On the randomized wound site, a SoC adhesive bandage will be applied.
On the randomized wound site, a antibiotic ointment will be applied.
On the randomized wound site, a antiseptic wash will be applied.
On the randomized wound site, hydrocolloid pad will be applied.
Time frame: Day 0 through Day 7
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.
Time frame: Day 16
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.
Time frame: Day 0 through Day 7, Day 16
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.
Time frame: Day 0 through Day 7, Day 16
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.
Time frame: Day 0 through Day 7, Day 16
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.
Time frame: Day 0 through Day 7, Day 16
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.
Time frame: Day 0 through Day 7, Day 16
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.
Time frame: Day 0 through Day 7, Day 16
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.
Time frame: Day 16
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).
Time frame: Day 0 through Day 7, Day 16
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).
Time frame: Day 0 through Day 7, Day 16
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).
Time frame: Day 0 through Day 7, Day 16
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).
Time frame: Day 0 through Day 7, Day 16
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).
Time frame: Day 0 through Day 7, Day 16
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).
Johnson & Johnson Consumer Inc. (J&JCI)
Industry
A 16-Day, Single-Center, Randomized, Comparator-Controlled Study to Assess Wound Healing Efficacies of Different Clean, Treat, and Protect Wound Care Regimens Compared to Standard of Care and Untreated
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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