Intact Skin Clinical Trial
Official title:
A Prospective, Monocentric, Open-Label Test of the HM242 Wound and Irrigation Solution and Gel on Healthy Skin to Evaluate Safety and Local Tolerability
It is the first clinical study aimed at assessing the safety and tolerability of
HM242-Solution and HM242-Gel after their application under occlusion on intact skin. The
HM242-Solution is intended for chronic wounds (e.g. pressure, venous leg and diabetic foot
ulcers). The HM242-Solution should be used for physical rinsing and cleansing and subsequent
decolonization of the wound prior to treatment with hydrogels and dressings. The HM242-Gel is
a hydrogel for wound bed preparation to support the healing of the skin due to cleansing,
moistening and subsequent decolonization and the coating of the wound.
The study will be conducted in outpatient manner, adult patients who are healthy and has an
intact skin.
This is an prospective, open label, monocentric study. No comparative control group is
planned as no other preventing infection solution is commercially available at this time.
The objective of this study is to assess the local tolerability and safety of HM242-Solution and HM242-Gel after their application under occlusion on intact skin. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03007264 -
Cold Plasma for Wound Treatment, Safety Study
|
Phase 1 |