Clinical trial NCT05690685: PMS Study of Silver I Alginate Non-Woven Dressing (Hydro-Alginate)
Official title: Post-market Surveillance Study to Confirm the Safety and Performance of Silver I Alginate Non-Woven Dressing (Hydro-Alginate) in Chronic and Acute Wounds
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Wound
Lead sponsor: Advanced Medical Solutions Ltd.
Sponsor class: INDUSTRY
Collaborators: name: NAMSA
First posted: 2023-01-19
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Evaluation of Wound progression following 6 weeks (Efficacy)
timeFrame: 6 weeks
measure: Subject incidence of any treatment-related adverse events during follow-up period - 6 weeks (Safety)
timeFrame: 6 weeks
Secondary outcomes:
measure: Pain assessment
timeFrame: 6 weeks
measure: Change in wound odour
timeFrame: 6 weeks
measure: Ease of use assessment using Likert-type scale
timeFrame: 6 weeks
measure: Change in wound granulation tissue
timeFrame: 6 weeks
measure: Percent change in wound size
timeFrame: 6 weeks
measure: Percent change in devitalized tissue
timeFrame: 6 weeks
measure: Rates of individual components of wound progression (primary efficacy endpoint)
timeFrame: 6 weeks
measure: The number of components of the primary efficacy endpoint experienced by each subject
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Bath
country: United Kingdom
facility: Royal United Hospital Bath
city: East Grinstead
country: United Kingdom
facility: Queen Victoria Hospital
Study officials:
References: