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

NCT07312513 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 104

Last updated 2025-12-31

No results posted yet for this study

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.

Conditions

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

Interventions

DEVICE

two sided debridement pad

two sided debridement pad

DEVICE

one sided debridment pad

one sided debridment pad

Sponsors & Collaborators

  • AXCELLANT

    collaborator UNKNOWN

  • Lohmann & Rauscher

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-09
Primary Completion
2026-02-28
Completion
2026-02-28

Countries

  • Poland

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 NCT07312513 on ClinicalTrials.gov