Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Bioskin GmbH | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Zoralan Wound | Experimental | At the beginning of the study, two small, superficial, abrasive wounds (approximately 1.2 cm in diameter) were induced on one volar forearm of each subject with a minimum distance of 5 cm between the wounds, using a sterile surgical hand brush. One wound is treated with the medical device by a study nurse and covered with standard semi-occlusive wound plaster (Hansaplast Sensitive wound plaster. Topical application of appoximately 0.2g per test field (approx. 1.2cm in diameter each) once daily during a 12-day treatment period (11 treatments). |
|
| No treatment | No Intervention | At the beginning of the study, two small, superficial, abrasive wounds (approximately 1.2 cm in diameter) were induced on one volar forearm of each subject with a minimum distance of 5 cm between the wounds, using a sterile surgical hand brush. One wound is not treated but covered with standard semi-occlusive wound plaster (Hansaplast Sensitive wound plaster. Covering happens once daily during a 12-day treatment period (11 treatments). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zoralan Wound | Device | 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). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Wound healing efficacy (clinical) | Clinical assessment of wound healing efficacy performed by investigator (6-point- reepithelialization score). 0 = 0% healing
| 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
| 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). | Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Local tolerability (clinical) | Clinical assessment of local tolerability performed by investigator (5-point-erythemascore). 0 = no reaction
| Day 2, Day 6, Day 8, Day 10 & Day 12 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Heinrich Siemetzki, M.D. | Bioskin GmbH | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bioskin GmbH | Hamburg | 20095 | Germany |
Not provided
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Local tolerability (global) | Global assessment of local tolerability performed by subject and investigator (5-point score). 0 = very good
| 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). | 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). | 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). | Day 2, Day 6, Day 8, Day 10 & Day 12 |
| Presence of crusts | Presence of crusts (Yes/No) | 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) | 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. | 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. | Day 1, Day 4, Day 6, Day 8, Day 10, Day 12 & Day 31 |