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

NCT05045183 | Completed

• 1 other identifier: CCSTOH003808
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Wound Healing

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (12)

• Clinical Grading of Wound Healing of Erythema

  Day 0 through Day 7, Day 16

• Clinical Grading of Wound Healing of Edema

  Day 0 through Day 7, Day 16

• Clinical Grading of Wound Healing of General Wound Appearance

  Day 0 through Day 7, Day 16

• Clinical Grading of Wound Healing of Smoothness

  Day 0 through Day 7, Day 16

• Clinical Grading of Wound Healing of Epithelial Confluence

  Day 0 through Day 7, Day 16

Study Arms (8)

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.

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.

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.

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.

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.

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.

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.

Device: Hydrocolloid Pad

Interventions

SoC Adhesive Bandage DEVICE

On the randomized wound site, a SoC adhesive bandage will be applied.

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 Ointment DRUG

On the randomized wound site, a antibiotic ointment will be applied.

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 Wash DRUG

On the randomized wound site, a antiseptic wash will be applied.

Treatment E: Antiseptic Wash Plus Antibiotic Ointment Plus SoC Adhesive Bandage; Treatment F: Antiseptic Wash Plus Antibiotic Ointment Plus SoC Adhesive Bandage

Hydrocolloid Pad DEVICE

On the randomized wound site, hydrocolloid pad will be applied.

Treatment G: Hydrocolloid Pad; Treatment H: Hydrocolloid Pad

Eligibility Criteria

• Age: 25 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Johnson & Johnson Consumer Inc. (J&JCI): lead

Study Sites (1)

SGS Stephens, Inc. Dallas Research Center

Richardson, Texas, 75081, United States

Location

Related Publications (7)

• 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.

  PMID: 7808826 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.

  PMID: 14007593 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.

  PMID: 16752710 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

  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.

  PMID: 21247665 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.

  BACKGROUND

Related Links

• Related Info

Study Officials

• Tanja Emmerich, Ph.D.

  SGS Stephens, Inc. Dallas Research Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2021
• First Posted: September 16, 2021
• Study Start: September 8, 2021
• Primary Completion: October 6, 2021
• Study Completion: October 15, 2021
• Last Updated: March 25, 2025

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will share

Locations

US (1)