Completed

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.

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Zoralan Wound

Device
Who is being recruted

Wounds and Injuries

Over 18 Years
+22 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: January 2020
See protocol details

Summary

Principal SponsorOystershell NV
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: January 14, 2020

Actual date on which the first participant was enrolled.

The study focuses on evaluating a new wound care hydrogel to see how well it helps wounds heal and how effectively it cools the affected area. It is conducted on individuals with minor skin wounds created using a gentle abrasive method. This research is important because finding effective ways to promote faster and more comfortable healing of wounds can significantly improve the quality of care for people dealing with skin injuries. Participants in the study receive the hydrogel treatment directly on their wounds. The healing is measured by looking at how much the skin has re-grown over the wound, known as re-epithelialization. Cooling effects are checked right after the first application. The study also evaluates how well the skin tolerates the treatment, checking for any irritation or discomfort. Cosmetic outcomes are assessed by both the investigator and the participants using a visual scale, and participants also fill out a questionnaire about their experience with the product. The study tracks how long it takes for the wounds to fully or mostly heal, providing valuable insights into the hydrogel's effectiveness.

Official TitleAssessment 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.
NCT06309446
Principal SponsorOystershell NV
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

33 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Wounds and Injuries

Criteria

6 inclusion criteria required to participate
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;

Show More Criteria

16 exclusion criteria prevent from participating
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;

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

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).

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Bioskin GmbH

Hamburg, GermanyOpen Bioskin GmbH in Google Maps
CompletedOne Study Center