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.
Zoralan Wound
Wounds and Injuries
Treatment Study
Summary
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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.33 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.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
Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy 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