WoundNCT06309446
Assessment of Wound Healing, Cooling Efficacy and Local Tolerability of a Wound Care Hydrogel
A study testing Zoralan Wound in people with Wound, run by Oystershell NV at 1 site in Germany.
Trial summary
Test the wound healing properties of the product as well as the cooling effect and tolerability of a wound care gel. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Wound
- What is being tested?
- Zoralan Wound
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteGermany
- Study dates
- 14 Jan 2020to 2 Jul 2020
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men and women aged 18 years or older;
- Healthy skin on the volar forearms;
- The physical examination of the skin must be without disease findings unless the investigator considers an abnormality to be irrelevant to the outcome of the clinical investigation;
- Female volunteers of childbearing potential must either be surgically sterile (hysterectomy or tubal ligation) or agree to use a reliable method of contraception with a failure rate of less than 1% per year when used consistently and correctly such as implants, injectables, combined oral contraceptives, some intra uterine devices (IUDs), sexual abstinence or vasectomized partner;
- Urine pregnancy test negative for all females;
- Written informed consent obtained.
Who cannot join
- Acne, suntan, eczema, scars, excessive hair, acute skin infection or skin disease, hyper or hypopigmentation or tattoos in the test fields;
- Dark-skinned persons (Fitzpatrick skin types IV-VI);
- Pregnancy or planned pregnancy or nursing;
- Symptoms of a clinically significant illness that may influence the outcome of the investigation in the 4 weeks before baseline and during the clinical investigation;
- Participation in the treatment phase in another clinical investigation or clinical trial within the last 4 weeks prior to the baseline visit of this clinical investigation and during the conduct of this investigation;
- Known hypersensitivity or known allergic reactions to components of the MD or the protective standard wound plaster used;
Show all 16Show fewer
- Treatment with systemic medications or medications acting locally in the test field areas which might counter or influence the investigation aim within 2 weeks before the baseline visit (e.g. antihistamines or glucocorticosteroids) and during the conduct of this investigation;
- Subjects who have taken any anticoagulant medication, within 3 weeks prior to Day 1, or platelet aggregation inhibitors within 10 days prior to Day 1 or with a history of hemophilia or any other illness influencing the subject's coagulation system.
- Subjects with diabetes mellitus or presence or history of psoriasis, atopic dermatitis, lichen ruber planus, impaired wound healing or keloid development;
- Contraindications according to the package leaflet/instructions of use (Hansaplast Sensitive);
- If in the opinion of the investigator or physician performing the initial examination the subject should not participate in the clinical investigation, e.g. due to probable noncompliance or inability to understand the investigation and adequately given informed consent;
- Subjects not willing to adhere to trial restrictions, amongst others sauna, solarium are not allowed during the clinical investigation;
- Close affiliation with the investigator (e.g. a close relative) or persons working at bioskin GmbH or subject is an employee of the sponsor;
- Subject with a disposition to develop hypertrophic scarring, keloids or wound healing disorders;
- Evidence of drug or alcohol abuse;
- Subject is institutionalized because of legal or regulatory order.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Wound Healing, Cooling Efficacy and Local Tolerability of a Wound Care Hydrogel With Intraindividual Comparison Using an Abrasive Wound Model in a Single-center, Randomized, Investigatorblind Clinical Investigation.
Test the wound healing properties of the product as well as the cooling effect and tolerability of a wound care gel.
Read the detailed description
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.
- Conditions
- Wound
- Being tested
- Zoralan Wound
- Keywords
- Wound healing
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zoralan WoundDevice
Also called Flamozil, Wound care hydrogel, X92001574
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).
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Device: Zoralan Wound |
| 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wound healing efficacy (clinical)
Clinical assessment of wound healing efficacy performed by investigator (6-point- reepithelialization score).
0 = 0% healing
- = 1-25% re-epithelialization
- = 26-50% re-epithelialization
- = 51-75% re-epithelialization
- = over 75% but not complete re-epithelialization
- = 100% complete healing
Measured: 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
- = good
- = acceptable
- = poor
- = very poor
Measured: 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).
Measured: Day 1
Secondary outcomes (9)
Local tolerability (clinical)
Clinical assessment of local tolerability performed by investigator (5-point-erythemascore).
0 = no reaction
- = slight uniform or spotty erythema or slight diffuse, partial or follicular erythema
- = clear, sharply demarcated erythema
- = severe erythema with infiltrate
- = severe erythema with infiltrate and/or epidermal defect (blisters, blebs, erosions)
Measured: 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
- = good
- = acceptable
- = poor
- = very poor
Measured: 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).
Measured: 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).
Measured: 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).
Measured: Day 2, Day 6, Day 8, Day 10 & Day 12
Presence of crusts
Presence of crusts (Yes/No)
Measured: 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)
Measured: 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.
Measured: 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.
Measured: Day 1, Day 4, Day 6, Day 8, Day 10, Day 12 & Day 31
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2024
- Study start14 Jan 2020
- Primary completion19 Feb 2020
- Study completion2 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for WoundStudies 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
- Single group
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oystershell NV
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Bioskin GmbH
- Responsible party
- Sponsor
- Investigators
- Heinrich Siemetzki, M.D., Principal investigator, Bioskin GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06309446
- Sponsor's protocol ID
- 381001BS
- Status last verified
- Mar 2024
- First submitted
- 28 Feb 2024
- Last updated
- 13 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Wound Healing, Cooling Efficacy and Local Tolerability of a Wound Care Hydrogel With Intraindividual Comparison Using an Abrasive Wound Model in a Single-center, Randomized, Investigatorblind Clinical Investigation.
- ClinicalTrials.gov ID
- NCT06309446
- Acronym / sponsor ID
- 381001BS
- Conditions
- Wound
- Keywords
- Wound healing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Oystershell NVIndustry (pharma, biotech, devices)
- Collaborators
- Bioskin GmbH
- Study start
- 14 Jan 2020 (actual)
- Primary completion
- 19 Feb 2020 (actual)
- Study completion
- 2 Jul 2020 (actual)
- First posted
- 13 Mar 2024 (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.
Test the wound healing properties of the product as well as the cooling effect and tolerability of a wound care gel.
Detailed description
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Zoralan Wound | Experimental | Device: Zoralan WoundAt 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Men and women aged 18 years or older;
- Healthy skin on the volar forearms;
- The physical examination of the skin must be without disease findings unless the investigator considers an abnormality to be irrelevant to the outcome of the clinical investigation;
- Female volunteers of childbearing potential must either be surgically sterile (hysterectomy or tubal ligation) or agree to use a reliable method of contraception with a failure rate of less than 1% per year when used consistently and correctly such as implants, injectables, combined oral contraceptives, some intra uterine devices (IUDs), sexual abstinence or vasectomized partner;
- Urine pregnancy test negative for all females;
Key exclusion criteria (16 listed)
- Acne, suntan, eczema, scars, excessive hair, acute skin infection or skin disease, hyper or hypopigmentation or tattoos in the test fields;
- Dark-skinned persons (Fitzpatrick skin types IV-VI);
- Pregnancy or planned pregnancy or nursing;
- Symptoms of a clinically significant illness that may influence the outcome of the investigation in the 4 weeks before baseline and during the clinical investigation;
- Participation in the treatment phase in another clinical investigation or clinical trial within the last 4 weeks prior to the baseline visit of this clinical investigation and during the conduct of this investigation;
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 |
|---|---|---|
| Zoralan WoundAlso: Flamozil, Wound care hydrogel, X92001574Topical 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). | Device | Zoralan Wound |
Primary outcome
Wound healing efficacy (clinical)
Time frame: Day 2, Day 6, Day 8, Day 10 & Day 12
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
Wound healing efficacy (global)
Time frame: Day 2, Day 6, Day 8, Day 10 & Day 12
Global assessment of wound healing efficacy performed by investigator (5-point score). 0 = very good 1. = good 2. = acceptable 3. = poor 4. = very poor
Cooling properties
Time frame: Day 1
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).
9 secondary outcomes
Local tolerability (clinical)
Time frame: Day 2, Day 6, Day 8, Day 10 & Day 12
Local tolerability (global)
Time frame: Day 2, Day 6, Day 8, Day 10 & Day 12
Signs of infection
Time frame: Day 2, Day 6, Day 8, Day 10 & Day 12
Time until 100% healing
Time frame: Day 2, Day 6, Day 8, Day 10 & Day 12
Time until 75% healing
Time frame: Day 2, Day 6, Day 8, Day 10 & Day 12
Presence of crusts
Time frame: Day 2, Day 6, Day 8, Day 10 & Day 12
Questionnaire on product performance
Time frame: Day 12
Cosmetic outcome/acceptance
Time frame: Day 31
Photographic documentation of the wound - visual of the wound to support previous outcomes.
Time frame: Day 1, Day 4, Day 6, Day 8, Day 10, Day 12 & Day 31
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 13 Mar 2024.
Related trials for Wound
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Not yet recruiting
Safety Study of Microlyte DualGuard
Wound Closure, Wound Care
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
Recruiting
Effects of Cervicothoracic Mobilization in Patients With Supraspinatus Tendinitis
Rotator Cuff Tendonitis
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.
Heinrich Siemetzki, M.D. principal investigator
Bioskin GmbH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Zoralan Wound in people with Wound, run by Oystershell NV at 1 site in Germany.
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 6 inclusion and 16 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 13 Mar 2024. 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 Germany. 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?
Wound healing efficacy (clinical) (time frame: Day 2, Day 6, Day 8, Day 10 & Day 12). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Mar 2024.