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NCT05690685
PMS Study of Silver I Alginate Non-Woven Dressing (Hydro-Alginate)
Conditions: Wound
Sex: All
Ages: 18 Years – N/A
Phase: NA
Enrollment: 60
Sponsor: Advanced Medical Solutions Ltd.
Summary
Post market surveillance study to confirm the ongoing safety and performance of Silver I Alginate Non-Woven Dressing (Hydro-Alginate) in chronic and acute wounds.
Eligibility Criteria
Inclusion Criteria:Males or females, age 18 years or above.
(Females must not be pregnant and if of reproductive age should provide a negative pregnancy test at screening).Patients who are able to understand and give informed consent to take part in the study.Have one or more of the following: Pressure ulcer or Donor site wounds that are infected, or are at high risk of infection (in the opinion of the Investigator), that are moderate to heavy levels of exudate.Pressure ulcers that are moderate to high exudate, typically Category 3 and 4.Only one primary wound may be treated per patient for the study.Exclusion Criteria:Patients who are known to be non-compliant with medical treatment,Patients who are known to be sensitive to any of the device componentsSubject is pregnant or actively breastfeeding;Subject has a known sensitivity to Silver;Life expectancy of <6 months;Subject has any significant or unstable medical or psychiatric condition that, in the opinion of the Investigator, would interfere with his/her ability to participate in the study;Subject is currently enrolled in another clinical study, or has completed a clinical study less than 30 days prior to enrolment.
Source: ClinicalTrials.gov (NCT05690685). StuddyBuddy aggregates publicly available trial information.