Assessment of Wound Healing, Cooling Efficacy and Local Tolerability of a Wound Care Hydrogel

Not Applicable

Completed

• Conditions: Wound
• Interventions: Device: Zoralan Wound

• Registration Number: NCT06309446
• Lead Sponsor: Oystershell NV

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.

Study Timeline

• Study Start: 2020-01-14
• Primary Completion: 2020-02-19
• Study Completion: 2020-07-02
• Study First Submitted: 2024-02-28
• Status Verified: 2024-03
• Study First Submitted QC: 2024-03-07
• Last Update Submitted: 2024-03-07
• Study First Posted: 2024-03-13
• Last Update Posted: 2024-03-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Zoralan Wound	Zoralan Wound	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).

Primary Outcome Measures

Name	Time	Method
Wound healing efficacy (clinical)	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)	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	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).

Secondary Outcome Measures

Name	Time	Method
Time until 100% healing	Day 2, Day 6, Day 8, Day 10 & Day 12	Time until 100% healing, defined as first day after wound induction with reepithelialization score of 5 (5 = 100% complete healing).
Time until 75% healing	Day 2, Day 6, Day 8, Day 10 & Day 12	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).
Presence of crusts	Day 2, Day 6, Day 8, Day 10 & Day 12	Presence of crusts (Yes/No)
Local tolerability (global)	Day 2, Day 6, Day 8, Day 10 & Day 12	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
Questionnaire on product performance	Day 12	Questionnaire on product performance (filled by subjects) on Day 12 (12 closed questions)
Photographic documentation of the wound - visual of the wound to support previous outcomes.	Day 1, Day 4, Day 6, Day 8, Day 10, Day 12 & Day 31	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.
Local tolerability (clinical)	Day 2, Day 6, Day 8, Day 10 & Day 12	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)
Signs of infection	Day 2, Day 6, Day 8, Day 10 & Day 12	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).
Cosmetic outcome/acceptance	Day 31	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.

Trial Locations

Locations (1)

Bioskin GmbH; 🇩🇪 Hamburg, Germany