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

NCT06309446 | Completed

• 1 other identifier: 381001BS
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

Test the wound healing properties of the product as well as the cooling effect and tolerability of a wound care gel.

Conditions

Wound

Keywords

Wound healing

Outcome Measures

Primary Outcomes (3)

• 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

  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

  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

Secondary Outcomes (9)

• Local tolerability (clinical)

  Day 2, Day 6, Day 8, Day 10 & Day 12

• Local tolerability (global)

  Day 2, Day 6, Day 8, Day 10 & Day 12

• Signs of infection

  Day 2, Day 6, Day 8, Day 10 & Day 12

• Time until 100% healing

  Day 2, Day 6, Day 8, Day 10 & Day 12

• Time until 75% healing

  Day 2, Day 6, Day 8, Day 10 & Day 12

Study Arms (2)

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).

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).

Interventions

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).

Also known as: Flamozil, Wound care hydrogel, X92001574

Zoralan Wound

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Oystershell NV: lead
• Bioskin GmbH: collaborator

Study Sites (1)

Bioskin GmbH

Hamburg, 20095, Germany

Location

MeSH Terms

Conditions

Wounds and Injuries

Study Officials

• Heinrich Siemetzki, M.D.

  Bioskin GmbH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2024
• First Posted: March 13, 2024
• Study Start: January 14, 2020
• Primary Completion: February 19, 2020
• Study Completion: July 2, 2020
• Last Updated: March 13, 2024

Record last verified: 2024-03

Locations

DE (1)