PMS Study of Silver I Alginate Non-Woven Dressing (Hydro-Alginate)

Advanced Medical Solutions

Status: Completed

Conditions: Wound

Treatments: Device: Silver I Alginate Non-Woven Dressing (Hydro-Alginate)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05690685

Silver I Alginate NonWoven 001

Details and patient eligibility

About

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.

Full description

Design: The design of the study is an open-label, multicentre, single arm clinical trial in subjects with moderate to heavily exuding chronic and acute wounds consisting of Pressure ulcers and Donor sites.

The rationale for the chosen study design and objectives is based on the requirement for further confirmation of the clinical effectiveness and safety of the dressing in routine clinical use, in terms of management of wound, management of bioburden, maintaining a moist wound environment, and exudate management.

This post market study has been designed to be an in-market clinical evaluation. Using the assessment scale of "satisfactory" or "not satisfactory" will indicate whether the device is acceptable to the Healthcare Professional and therefore demonstrate the acceptability of the Silver I Alginate Non-Woven dressing (Hydro-Alginate).

It is intended to recruit 25-30 subjects per wound type in support of providing evidence of effectiveness and safety of wound dressings. The prior CE-marking evaluation for this device lacked information pertaining to the use of the device in pressure ulcers or donor site wounds. Therefore, this study will address this gap. This study analysis will be descriptive in nature, for each wound type and will not be based on any stand-alone statistical hypotheses.

The study endpoints have been chosen because they will demonstrate the safety and effectiveness of the dressing in routine clinical use.

Enrollment: 56 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. 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).
2. Patients who are able to understand and give informed consent to take part in the study.
3. 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.
4. Pressure ulcers that are moderate to high exudate, typically Category 3 and 4.
5. Only one primary wound may be treated per patient for the study.

Exclusion criteria

1. Patients who are known to be non-compliant with medical treatment,
2. Patients who are known to be sensitive to any of the device components
3. Subject is pregnant or actively breastfeeding;
4. Subject has a known sensitivity to Silver;
5. Life expectancy of <6 months;
6. 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;
7. Subject is currently enrolled in another clinical study, or has completed a clinical study less than 30 days prior to enrolment.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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56 participants in 1 patient group

Silver I Alginate Non-Woven Dressing (Hydro-Alginate)

Experimental group

Description:

Subjects will undergo treatment of their chronic or acute wound (Pressure ulcer, and Donor sites) as indicated in the instructions for use with Silver I Non-Woven Dressing

Treatment:

Device: Silver I Alginate Non-Woven Dressing (Hydro-Alginate)