Clinical trial NCT06309446: Assessment of Wound Healing, Cooling Efficacy and Local Tolerability of a Wound Care Hydrogel
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Wound
Keywords: Wound healing
Lead sponsor: Oystershell NV
Sponsor class: INDUSTRY
Collaborators: name: Bioskin GmbH
First posted: 2024-03-13
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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;
* 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.

Primary outcomes:
measure: Wound healing efficacy (clinical)
timeFrame: Day 2, Day 6, Day 8, Day 10 & Day 12
measure: Wound healing efficacy (global)
timeFrame: Day 2, Day 6, Day 8, Day 10 & Day 12
measure: Cooling properties
timeFrame: Day 1
Secondary outcomes:
measure: Local tolerability (clinical)
timeFrame: Day 2, Day 6, Day 8, Day 10 & Day 12
measure: Local tolerability (global)
timeFrame: Day 2, Day 6, Day 8, Day 10 & Day 12
measure: Signs of infection
timeFrame: Day 2, Day 6, Day 8, Day 10 & Day 12
measure: Time until 100% healing
timeFrame: Day 2, Day 6, Day 8, Day 10 & Day 12
measure: Time until 75% healing
timeFrame: Day 2, Day 6, Day 8, Day 10 & Day 12
measure: Presence of crusts
timeFrame: Day 2, Day 6, Day 8, Day 10 & Day 12
measure: Questionnaire on product performance
timeFrame: Day 12
measure: Cosmetic outcome/acceptance
timeFrame: Day 31
measure: Photographic documentation of the wound - visual of the wound to support previous outcomes.
timeFrame: Day 1, Day 4, Day 6, Day 8, Day 10, Day 12 & Day 31
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: Bioskin GmbH
Study officials:
affiliation: Bioskin GmbH
name: Heinrich Siemetzki, M.D.
role: PRINCIPAL_INVESTIGATOR
References: