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To Evaluate the Safety and Performance of the AMS ActivHeal Silicone Foam and the ActivHeal Silicone Foam Lite Dressing.

NCT04621838 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2022-05-12

No results posted yet for this study

Summary

To demonstrate the safety and performance of both AMS ActivHeal Silicone Foam and AMS ActivHeal Silicone Foam Lite dressings to both the patient and clinician in managing both chronic and acute wounds.

Conditions

  • Wound

Interventions

OTHER

Assigned interventions.

Subjects will undergo treatment of their chronic and acute wounds as indicated in instructions for use, with Silicone Foam Dressing and Silicone Foam Lite Dressing. The patients will be evaluated at each dressing change over a six-week period (per Product) or until the wound is healed to extent that the use of the Silicone Foam and Silicone Foam Lite dressing is no longer indicated from the time that the patient has been recruited.

Sponsors & Collaborators

  • Cliniscience Sp.

    collaborator UNKNOWN

  • Advanced Medical Solutions Ltd.

    lead INDUSTRY

Principal Investigators

  • Jacek Mikosiński, MD, PhD · Poradnia Chorób Naczyń Obwodowych MIKOMED

  • Katarzyna Rybołowicz, MD,PhD · Gabinet Ortopedyczny, Specjalistyczny Ośrodek Leczniczo-Badawczy,

  • Konrad Pańczak, MD,PhD · NZOZ Twój Lekarz Kobierzyce,

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-04-21
Primary Completion
2022-01-30
Completion
2022-02-28

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 NCT04621838 on ClinicalTrials.gov