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

Wound Clinical Trial

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.

Clinical Trial Summary

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

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06309446
Study type Interventional
Source Oystershell NV
Contact
Status Completed
Phase N/A
Start date January 14, 2020
Completion date July 2, 2020
View Details
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