RecruitingNot ApplicableNCT07312513

Multicenter, Randomized, Non-inferiority Study to Compare the Performance and Safety of Debrisoft® Duo With Debrisoft® Pad in the Debridement of Wounds

Sponsor

Lohmann & Rauscher

Enrollment

104 participants

Start Date

May 9, 2025

Study Type

INTERVENTIONAL

Conditions

Pressure ulcers Burns and Scalds Diabetic Ulcers Epidermolysis Bullosa (EB)Arterial Ulcers Venous Ulcers Traumatic Wounds Surgical Wounds Postoperative Wounds Healing by Secondary Intention

Summary

The aim of this post market clinical follow up (PMCF) study is to confirm the performance of Debrisoft® Duo, to collect safety data regarding expected adverse events and to detect potential unexpected adverse events associated with the use of Debrisoft® Duo within the certified indications and under the conditions of routine use.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called one sided debridment pad and a medical device called two sided debridement pad for people with arterial ulcers, burns and scalds, and other related conditions. The study is currently recruiting participants at 5 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DEVICEtwo sided debridement pad

two sided debridement pad

DEVICEone sided debridment pad

one sided debridment pad

Locations(5)

MelissaMed Poradnia

Lodz, Poland

MIKOMED Sp. z.o.o.

Lodz, Poland

NZOZ Neuromed M. i M. Nastaj

Lublin, Poland

Specjalistyczny Osrodek Leczniczo Badawczy

Ostróda, Poland

Lecran - Centrum Opieki Nad Ranami-Kunickiego

Wroclaw, Poland

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07312513

Related Trials

THERAVEX Tissue Care Spray Plus for the Management of Cutaneous Wounds, Burns, and Chronic Ulcers

NCT076179611 location

A Phase 2 Study of TCP-25 Gel in Patients With Epidermolysis Bullosa, STEP-study

NCT065943939 locations