Test the wound healing properties of the product as well as the cooling effect and tolerability of a wound care gel.
The primary goal of the study is to assess the wound healing properties in the test fields, based on the level of re-epithelialization, and to assess the cooling properties in the test fields, immediately after the first application of the Medical Device. The secondary objective was to assess the local tolerability of the test fields after inducing the wounds. The cosmetic outcome was assessed by the investigator and by the subject after 31 days using a visual analog scale (VAS) and by the subjects on day 12 by filling a questionnaire on product performance and times to 100% healing, over 75% healing respectively were derived from the re-epithelization score.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
33
Topical application of approximately 0.2 g per test field (approx. 1.2 cm in diameter each) once daily during a 12-day treatment period (11 treatments).
Bioskin GmbH
Hamburg, Germany
Wound healing efficacy (clinical)
Clinical assessment of wound healing efficacy performed by investigator (6-point- reepithelialization score). 0 = 0% healing 1. = 1-25% re-epithelialization 2. = 26-50% re-epithelialization 3. = 51-75% re-epithelialization 4. = over 75% but not complete re-epithelialization 5. = 100% complete healing
Time frame: Day 2, Day 6, Day 8, Day 10 & Day 12
Wound healing efficacy (global)
Global assessment of wound healing efficacy performed by investigator (5-point score). 0 = very good 1. = good 2. = acceptable 3. = poor 4. = very poor
Time frame: Day 2, Day 6, Day 8, Day 10 & Day 12
Cooling properties
Subjective assessment of cooling properties performed by subject by completing a visual analogue scale on Day 1 immediately after application of the Medical Device (MD).The cooling effect in the two test fields will be assessed by the subject by means of a visual analogue scale (VAS) of 100 mm length, ranging from 0 (no cooling) to 100 (extremely cooling) on Day 1, 20 ±5 seconds after application of the MD (but prior to application of the protective wound plaster).
Time frame: Day 1
Local tolerability (clinical)
Clinical assessment of local tolerability performed by investigator (5-point-erythemascore). 0 = no reaction 1. = slight uniform or spotty erythema or slight diffuse, partial or follicular erythema 2. = clear, sharply demarcated erythema 3. = severe erythema with infiltrate 4. = severe erythema with infiltrate and/or epidermal defect (blisters, blebs, erosions)
Time frame: Day 2, Day 6, Day 8, Day 10 & Day 12
Local tolerability (global)
Global assessment of local tolerability performed by subject and investigator (5-point score). 0 = very good 1. = good 2. = acceptable 3. = poor 4. = very poor
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Day 2, Day 6, Day 8, Day 10 & Day 12
Signs of infection
Assessment of signs of infection, considering the following parameters: erythema, pain, malodor, delayed wound healing, excessive exudate, and heat, by investigator (closed question: YES/NO).
Time frame: Day 2, Day 6, Day 8, Day 10 & Day 12
Time until 100% healing
Time until 100% healing, defined as first day after wound induction with reepithelialization score of 5 (5 = 100% complete healing).
Time frame: Day 2, Day 6, Day 8, Day 10 & Day 12
Time until 75% healing
Time until over 75% healing, defined as first day after wound induction with reepithelialization score of 4 or 5 (4 = over 75% but not complete re-epithelialization; 5 = 100% complete healing).
Time frame: Day 2, Day 6, Day 8, Day 10 & Day 12
Presence of crusts
Presence of crusts (Yes/No)
Time frame: Day 2, Day 6, Day 8, Day 10 & Day 12
Questionnaire on product performance
Questionnaire on product performance (filled by subjects) on Day 12 (12 closed questions)
Time frame: Day 12
Cosmetic outcome/acceptance
The cosmetic outcome/acceptance will be assessed by the investigator and the subject by means of a visual analogue scale (VAS) of 100 mm length, ranging from 0 (poor) to 10 (excellent) on Day 31±2 for each of the two test fields.
Time frame: Day 31
Photographic documentation of the wound - visual of the wound to support previous outcomes.
High-quality photographic documentation of the test sites on Days 1, 4, 6, 8, 10, 12 and 31 sufficient time (not earlier than 30 minutes but not later than 60 minutes) after removal of patches and product residues for any removal related erythema to subside.
Time frame: Day 1, Day 4, Day 6, Day 8, Day 10, Day 12 & Day 31