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

NCT04192123 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2020-07-17

No results posted yet for this study

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.

Conditions

  • Intact Skin

Interventions

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.

Sponsors & Collaborators

  • B. Braun Ltd. Centre of Excellence Infection Control

    lead INDUSTRY

Principal Investigators

  • Welf Prager, Dr. med · Dermatologische Praxis Prager & Partner

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-05-25
Primary Completion
2020-06-19
Completion
2020-06-19

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04192123 on ClinicalTrials.gov