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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
34
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.
SGS Stephens, Inc. Dallas Research Center
Richardson, Texas, United States
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.
Time frame: 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.
Time frame: Day 16
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.
Time frame: Day 0 through Day 7, Day 16
Clinical Grading of Wound Healing of Edema
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
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.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
On the randomized wound site, hydrocolloid pad will be applied.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: Day 0 through Day 7, Day 16