Abrasion, Skin Wounds
Conditions
Keywords
superficial wounds, dexpanthenol, plaster
Brief summary
Clinical evaluation of a Dexpanthenol-medicated wound plaster on standardized superficial skin abrasions
Detailed description
By utilizing a standardized abrasion model (based on the Wigger-Alberti methodology), the study aims to quantify the superior clinical performance of the Plaster compared to a standard plaster (conventional dry) and dry healing (no plaster). This evidence is crucial to demonstrate that the presence of Dexpanthenol provides a significant clinical benefit in terms of healing speed and aesthetic quality of the repaired tissue.
Interventions
DEVICEhydrogel plaster with dexpanthenol
On the wound will be applied daily an hydrogel plaster with Dexpanthenol
DEVICEStandard plaster
On the wound will be daily applicated a standard plaster on the market
Sponsors
Wooshin Labottach Co., Ltd.
Nextrasearch S.r.l.s.
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Intervention model description
Randomized, Single-Blind (assessor blind), Intra-Individual Controlled study
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy male or female volunteers aged 18 to 64 years (inclusive). * Informed consent form signed voluntarily before any study-related procedure. * Subjects willing and able to comply with all study protocol requirements, including scheduled visits and home-wear restrictions. * Intact, healthy skin on both volar forearms (free of tattoos, scars, sunburns, or active skin lesions in the designated test areas). * Agree to take precautions to prevent pregnancy (applicable only to non-menopausal women), including abstinence, intrauterine devices (IUDs), progestogen implants, combined estrogenic-progestogen contraceptives, the use of condoms;
Exclusion criteria
* Known hypersensitivity or allergy to Dexpanthenol, hydrogel components, acrylic adhesives, or any component of the investigational devices. * History of keloid formation, hypertrophic scarring, or abnormal wound healing. * Active dermatological conditions (e.g., psoriasis, eczema, atopic dermatitis, active infections) on the upper extremities. * History of diabetes mellitus, peripheral vascular disease, or arterial/venous microangiopathy. * Systemic treatment with corticosteroids, immunosuppressive drugs, Anticoagulants, antiplatelet agents or cytostatic agents within 4 weeks prior to Baseline, or anticipated need during the study. * Topical treatment (steroids, retinoids, antibiotics, or moisturizers) applied to the volar forearms within 2 weeks prior to Baseline. * Active heavy smokers (more than 10 cigarettes per day) or users of nicotine-replacement therapies (nicotine alters cutaneous microcirculation and significantly impairs wound healing kinetics) * Pregnant or lactating women, or women of childbearing potential not using highly effective contraception (see inclusion criteria). * Not willing and able to comply with all study protocol requirements
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Re-epithelialization Rate | day 5 day 7 day 15 | Measured as the percentage of wound closure compared to baseline (T0) with standardized photography |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Kinetics of Wound Closure | Day 5 day 7 | Time to 50% re-epithelialization |
| Subject-Reported Pain | day 5 day 7 | Pain during wear and upon plaster removal assessed via a 100-mm Visual Analogue Scale (VAS) |
| Scar Quality Assessment | day 5 day 7 day 15 | using the Vancouver Scar Scale (VSS) (scoring vascularity, pigmentation, pliability, and height) |
| general usability | Day 1, day 5, day 7 | Assessment of the plaster adherence to the perilesional skin over the treatment period using a 5-Point Adhesion Score 0 (100%) to 4 (0% fallen) |
Countries
Italy
Contacts
CONTACTAlessandro Guzzo, MD
CONTACTAdolfo Gasparetto, MD
PRINCIPAL_INVESTIGATORAlessandro Guzzo, MD
la U.O.C. Anestesia Rianimazione degli Ospedali Riuniti Padova Sud con indirizzo via Albere, 30 Monselice
Outcome results
None listed