NCT04192123

Open-Label Test of the HM242 Medical Devices to Evaluate Safety and Local Tolerability

A Prospective, Monocentric, Open-Label Test of the HM242 Wound and Irrigation Solution and Gel on Healthy Skin to Evaluate Safety and Local Tolerability

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: B. Braun Ltd. Centre of Excellence Infection Control · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Intact Skin

Interventions

Type	Name	Description
DEVICE	HM242	HM242-Solution and HM242-Gel will be topically applied in an occlusive patch for 48h on healthy skin on the subject's outer part of the upper arm.

Timeline

• Start date: 2020-05-25
• Primary completion: 2020-06-19
• Completion: 2020-06-19
• First posted: 2019-12-10
• Last updated: 2020-07-17

Locations

1 site across 1 country: Germany