Wound HealingNCT05045183

A Study to Assess Wound Healing Efficacies of Different Clean, Treat, and Protect Wound Care Regimens Compared to Standard of Care and Untreated

A study testing SoC Adhesive Bandage, Antibiotic Ointment and Antiseptic Wash in people with Wound Healing, run by Johnson & Johnson Consumer Inc. (J&JCI) at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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. Read more about this study

Who is it for?: Ages 25 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Wound Healing
What is being tested?: SoC Adhesive Bandage, Antibiotic Ointment and Antiseptic Wash
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 34 participants
Where: 1 siteUnited States
Study dates: 8 Sep 2021to 15 Oct 2021
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 25 to 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Fitzpatrick Skin Type I to III
Uniform skin color on both volar forearms
Generally in good health based on medical history reported by the participant, and as verified by the Principal Investigator (PI) assessment and brief interview of medical history
Able to read, write, speak, and understand English
Individual must be able to understand the nature, risk, and relevance of the study
Individual has signed the Consent for Photograph Release and informed consent document (ICD) including Health Insurance Portability and Accountability Act (HIPAA) disclosure after the nature of the study has been fully explained

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Willing to undergo topical anesthetic and laser wound treatment on the volar forearms
Individual must agree to attend all required study visits, cooperate/follow all study instructions, and participate with all the procedures for the duration of the study and return to the clinical site for all scheduled visits as required by the investigator
Willing to wear long sleeves when going outdoors during the study to protect the test areas from exposure to sunlight. Individuals must agree to avoid exposing their forearms to sunlight (including tanning booths) throughout the entire study period
Individual must agree not to immerse their bandages in water for the duration of the study. Participants will only be allowed to shower during the course of the study (no swimming, baths, hot tubs, Et cetera [etc.]) Individuals must agree not to shower within 2 hours prior to each scheduled visit
Individuals must agree not to use lotions, creams, moisturizers, cosmetics, or sunscreens on their forearms (sites of wounds) for the entire duration of the study
Individuals must agree to refrain from the use of any daily cleanser or washoff products other than the auxiliary cleanser that will be provided at screening (that is, [Day -7 to Day -3]), for use on forearms throughout the study

Who cannot join

Has known allergies, hypersensitivity, or adverse reactions to anesthetics, adhesive bandages, latex, wound treatment products, or any component/ingredient present in the investigational products (IPs)/auxiliary/ancillary products
Has a known history of a blood-clotting disorder, cardiovascular, hepatic, or kidney disease
Presents with a known history of keloid or hypertrophic scar formation, cracked or excoriated skin, clinical infected skin lesions, or other skin problems that would in the opinion of the PI or Study Physician, confound the study results, increase risk to the participant, or interfere with study evaluations (example, active psoriasis anywhere on the body, seborrheic dermatitis, atopic dermatitis, other skin dermatoses, etc.)
Has excessive hair, acne, scars, pigmentation, tattoos, or friable skin on either volar forearm that could interfere with evaluations or study procedures (at the discretion of the PI)
Has a known history of severe systemic immune system disorders such as Systemic Lupus Erythematosus (SLE), Rheumatoid Arthritis (RA), Scleroderma, chronic connective tissue disorders, Poly Arteritis Nodosa, or immunodeficiency, including human immunodeficiency viruses (HIV) infection
Has a history of a confirmed Coronavirus Disease 2019 (COVID-19) infection within 30 days prior to Visit 1

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Has had contact with a COVID-19 infected person within 14 days prior to Visit 1
Individual or a member of the individual's household who has traveled internationally within 14 days prior to Visit 1
Has experienced any of the following self-reported symptoms of COVID-19 within 2 weeks prior to the study visit: a) Unexplained cough, shortness of breath/difficulty breathing, fatigue, body aches (headaches, muscle pain, stomachaches) conjunctivitis, loss of smell, loss of taste, poor appetite, nausea, vomiting, diarrhea, palpitations, fever, or chest pain/tightness; b) Temperature greater than or equal to (>=) 37.2 degree Celsius (°C)/99.5 degree Fahrenheit (°F), measured; c) Use of fever reducers within 2 days prior to each on-site study visit
Has self-reported Type 1 or Type 2 diabetes or is taking insulin or another anti-diabetic medication
Has self-reported uncontrolled chronic diseases such as hypertension, hyperthyroidism, hypothyroidism, or active or recently treated (within 1 year) skin cancer, or those in known poor nutritional status
Is taking a medication that would mask an Adverse Event (AE), confound the study results, or alter or compromise the bleeding/healing process including: a) Antibiotics, oral corticosteroids, immunosuppressive agents, anti-coagulants, antiplatelet drugs, cytotoxic agents, continuous aspirin therapy, chemotherapy, or daily medications for chronic asthma, within 1 month before Visit 1; b) Non-steroidal anti-inflammatory drugs or steroidal drugs within 5 days before Visit 1. Low dose aspirin (81 milligrams [mg] per day) is allowed; c) Antihistamines within 2 weeks before Visit 1
Is self-reported to be pregnant, lactating or planning to become pregnant during the study
Has taken/used (oral or topical) vitamin A derivatives such as Accutane, isotretinoin, or retinoic acid within the past 1 year, or using topical Vitamin A derivatives on the forearms in the 3 weeks prior to Visit 1.
Has used topical leave-on products on the volar forearms within 1 week prior to Visit 1
Is participating or has participated in 1) any clinical trial involving a topical or systemic investigational drug within 30 days prior to Visit 1 or 2) any other clinical study within 10 days prior to Visit 1
Has a body mass index (BMI) above 35 on the BMI scale. BMI will be calculated using height and weight measurements obtained by trained study personnel
Is self-reported to be an alcohol or drug abuser, or with any other known severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the PI, would make the participant inappropriate for entry into this study
Is an employee/contractor or immediate family member of the PI, Study Site, or Sponsor
Has a relative, partner, or staff of any clinical research site personnel, or either is or lives with someone who is a current employee of any company that makes or markets adhesive bandages or first aid products
Has a history of or a concurrent health/other condition/situation which may put the individual at significant risk, confound the study results, or interfere significantly with the individual's participation in the study or viewed by the PI as not being able to complete the study

Trial locations and contacts

1 site in 1 country.

United States1 site

SGS Stephens, Inc. Dallas Research Center
Richardson, Texas, 75081

Other trials in United States

About this study

Official title: 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

Conditions: Wound Healing
Being tested: SoC Adhesive Bandage, Antibiotic Ointment, Antiseptic Wash, Hydrocolloid Pad

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SoC Adhesive BandageDevice
On the randomized wound site, a SoC adhesive bandage will be applied.
Antibiotic OintmentDrug
On the randomized wound site, a antibiotic ointment will be applied.
Antiseptic WashDrug
On the randomized wound site, a antiseptic wash will be applied.
Hydrocolloid PadDevice
On the randomized wound site, hydrocolloid pad will be applied.

Study groups in NCT05045183
Study group	Role	What they receive
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. Receives: Device: SoC Adhesive Bandage
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. Receives: Drug: Antibiotic Ointment
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. Receives: Device: SoC Adhesive Bandage; Drug: Antibiotic Ointment
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. Receives: Device: SoC Adhesive Bandage; Drug: Antibiotic Ointment; Drug: Antiseptic Wash
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. Receives: Device: SoC Adhesive Bandage; Drug: Antibiotic Ointment; Drug: Antiseptic Wash
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. Receives: Device: Hydrocolloid Pad
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. Receives: Device: Hydrocolloid Pad

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: Day 16

Secondary outcomes (12)

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: Day 0 through Day 7, Day 16

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

8 Sep 202115 Oct 2021

First posted16 Sep 2021
Study start8 Sep 2021
Primary completion6 Oct 2021
Study completion15 Oct 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (7)Papers the sponsor has linked to this study.
Other trials for Wound HealingStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 34 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05045183
Sponsor's protocol ID: CCSTOH003808
Other IDs: CCSTOH003808
Status last verified: Oct 2022
First submitted: 6 Sep 2021
Last updated: 25 Mar 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: 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.

Publications

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.
PubMed 7808826
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.
PubMed 14007593
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.
PubMed 16752710
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
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
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.
PubMed 21247665
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.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 25 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT05045183
Acronym / sponsor ID: CCSTOH003808
Conditions: Wound Healing
Study type: Interventional
Recruitment status: Completed
Enrolment: 34 participants (actual)
Lead sponsor: Johnson & Johnson Consumer Inc. (J&JCI)Industry (pharma, biotech, devices)
Study start: 8 Sep 2021 (actual)
Primary completion: 6 Oct 2021 (actual)
Study completion: 15 Oct 2021 (actual)
First posted: 16 Sep 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 8

Arm	Type	Receives
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	Device: SoC Adhesive BandageMinor 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.
Treatment C: Antibiotic Ointment	Experimental	Drug: Antibiotic OintmentMinor 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.
Treatment D: Antibiotic Ointment Plus SoC Adhesive Bandage	Experimental	Device: SoC Adhesive Bandage, Drug: Antibiotic OintmentMinor 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.
Treatment E: Antiseptic Wash Plus Antibiotic Ointment Plus SoC Adhesive Bandage	Experimental	Device: SoC Adhesive Bandage, Drug: Antibiotic Ointment, Drug: Antiseptic WashMinor 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.
Treatment F: Antiseptic Wash Plus Antibiotic Ointment Plus SoC Adhesive Bandage	Experimental	Device: SoC Adhesive Bandage, Drug: Antibiotic Ointment, Drug: Antiseptic WashMinor 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.
Treatment G: Hydrocolloid Pad	Experimental	Device: Hydrocolloid PadMinor 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.
Treatment H: Hydrocolloid Pad	Experimental	Device: Hydrocolloid PadMinor 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.

Who may qualify

Ages: 25 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (12 listed)

Fitzpatrick Skin Type I to III
Uniform skin color on both volar forearms
Generally in good health based on medical history reported by the participant, and as verified by the Principal Investigator (PI) assessment and brief interview of medical history
Able to read, write, speak, and understand English
Individual must be able to understand the nature, risk, and relevance of the study

Key exclusion criteria (21 listed)

Has known allergies, hypersensitivity, or adverse reactions to anesthetics, adhesive bandages, latex, wound treatment products, or any component/ingredient present in the investigational products (IPs)/auxiliary/ancillary products
Has a known history of a blood-clotting disorder, cardiovascular, hepatic, or kidney disease
Presents with a known history of keloid or hypertrophic scar formation, cracked or excoriated skin, clinical infected skin lesions, or other skin problems that would in the opinion of the PI or Study Physician, confound the study results, increase risk to the participant, or interfere with study evaluations (example, active psoriasis anywhere on the body, seborrheic dermatitis, atopic dermatitis, other skin dermatoses, etc.)
Has excessive hair, acne, scars, pigmentation, tattoos, or friable skin on either volar forearm that could interfere with evaluations or study procedures (at the discretion of the PI)
Has a known history of severe systemic immune system disorders such as Systemic Lupus Erythematosus (SLE), Rheumatoid Arthritis (RA), Scleroderma, chronic connective tissue disorders, Poly Arteritis Nodosa, or immunodeficiency, including human immunodeficiency viruses (HIV) infection

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
SoC Adhesive BandageOn the randomized wound site, a SoC adhesive bandage will be applied.	Device	Treatment B: Standard of Care (SoC) Adhesive Bandage, Treatment D: Antibiotic Ointment Plus SoC Adhesive Bandage, Treatment E: Antiseptic Wash Plus Antibiotic Ointment Plus SoC Adhesive Bandage, Treatment F: Antiseptic Wash Plus Antibiotic Ointment Plus SoC Adhesive Bandage
Antibiotic OintmentOn the randomized wound site, a antibiotic ointment will be applied.	Drug	Treatment C: Antibiotic Ointment, Treatment D: Antibiotic Ointment Plus SoC Adhesive Bandage, Treatment E: Antiseptic Wash Plus Antibiotic Ointment Plus SoC Adhesive Bandage, Treatment F: Antiseptic Wash Plus Antibiotic Ointment Plus SoC Adhesive Bandage
Antiseptic WashOn the randomized wound site, a antiseptic wash will be applied.	Drug	Treatment E: Antiseptic Wash Plus Antibiotic Ointment Plus SoC Adhesive Bandage, Treatment F: Antiseptic Wash Plus Antibiotic Ointment Plus SoC Adhesive Bandage
Hydrocolloid PadOn the randomized wound site, hydrocolloid pad will be applied.	Device	Treatment G: Hydrocolloid Pad, Treatment H: Hydrocolloid Pad

Primary outcome

Composite Healing Score
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.
Composite Healing Score
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.

12 secondary outcomes

Clinical Grading of Wound Healing of Erythema
Time frame: Day 0 through Day 7, Day 16
Clinical Grading of Wound Healing of Edema
Time frame: Day 0 through Day 7, Day 16
Clinical Grading of Wound Healing of General Wound Appearance
Time frame: Day 0 through Day 7, Day 16
Clinical Grading of Wound Healing of Smoothness
Time frame: Day 0 through Day 7, Day 16
Clinical Grading of Wound Healing of Epithelial Confluence
Time frame: Day 0 through Day 7, Day 16
Clinical Grading of Wound Healing of Crusting/Scabbing
Time frame: Day 0 through Day 7, Day 16
Wound Healing Process Assessment Score
Time frame: Day 16
Painful Score with Arm Resting by Side (Participant's Self-assessment Questionnaire)
Time frame: Day 0 through Day 7, Day 16
Pain Duration with Arm Resting by Side (Participant's Self-assessment Questionnaire)
Time frame: Day 0 through Day 7, Day 16
Painful Score with Arm in Normal Motion (Participant's Self-assessment Questionnaire)
Time frame: Day 0 through Day 7, Day 16
Pain Duration with Arm in Normal Motion (Participant's Self-assessment Questionnaire)
Time frame: Day 0 through Day 7, Day 16
Itchy Score of Wound Site (Participant's Self-assessment Questionnaire)
Time frame: Day 0 through Day 7, Day 16

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2025.
Background: PubMed 7808826Mancini 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.
Background: PubMed 14007593WINTER 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.
Background: PubMed 16752710Winter 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.
BackgroundBernard 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
BackgroundCuts and scrapes: First aid. (2019, October 29). Retrieved January 22, 2021, from https://www.mayoclinic.org/first-aid/first-aid-cuts/basics/art-20056711
Background: PubMed 21247665Trookman 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.
BackgroundNIH 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.
Related InfoLink provided by the sponsor.
Individual participant dataSharing planned: Yes. 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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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Tanja Emmerich, Ph.D. principal investigator

SGS Stephens, Inc. Dallas Research Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing SoC Adhesive Bandage, Antibiotic Ointment and Antiseptic Wash in people with Wound Healing, run by Johnson & Johnson Consumer Inc. (J&JCI) at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Composite Healing Score (time frame: Day 0 through Day 7). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05045183, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2025.