NCT06309446

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

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.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: Oystershell NV · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Wound

Interventions

Type	Name	Description
DEVICE	Zoralan Wound	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).

Timeline

• Start date: 2020-01-14
• Primary completion: 2020-02-19
• Completion: 2020-07-02
• First posted: 2024-03-13
• Last updated: 2024-03-13

Locations

1 site across 1 country: Germany