Pressure UlcerNCT05494450
An Open, Non-comparative, Multicenter Investigation to Evaluate the Safety and Performance of Exufiber Ag+, a Gelling Fiber Silver Dressing, When Used in Medium to High Exuding Chronic Wounds
A study testing ExufiberAG+ in people with Pressure Ulcer and Diabetic Foot Ulcer, run by Molnlycke Health Care AB at 2 sites in United States.
Trial summary
An open, non-comparative, multicenter investigation to evaluate the safety and performance of Exufiber Ag+, a gelling fiber silver dressing, when used in medium to high exuding chronic wounds Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pressure Ulcer, Diabetic Foot Ulcer, Venous Leg Ulcer
- What is being tested?
- ExufiberAG+
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Jan 2022to 29 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed Informed Consent Form
- Patient aged ≥18 years old
- Patient with moderate to high exuding chronic wound (PU (stage II-IV), VLU or DFU)
- Patient with target wound that is a shallow to deep wound or cavity
- Patient with target wound that is ≥ 4 weeks in age
- Patient with target wound that is ≥ 8 cm2
Who cannot join
- Patient is contraindicated for the dressing according to product labeling
- Known allergy/hypersensitivity to any of the components of the investigation products
- Pregnancy/lactating female
- Patient with spreading soft tissue infection/cellulitis in the wound (as judged by the Investigator)
- Patient with known immunodeficiency
- Patient taking systemic antibiotics
Show all 13Show fewer
- Patient with the target wound located on an infected limb and/or interfered by minimal blood flow in the opinion of the Investigator.
- Patient with the target wound with an unexplored enteric fistula
- Patient requiring treatment with oxidizing agents such as hypochlorite solutions or hydrogen peroxide
- Patient who, in the opinion of the Investigator, is not expected to comply with the investigation due to physical and/or mental conditions
- Patient who was previously enrolled in this investigation
- Patient participating in other investigations that would preclude the subject from participating in this investigation as judged by the Investigator
- Patient involved in the planning and conduct of the clinical investigation (applies to all Mölnlycke staff, investigational site staff, and third party vendor)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Sycamore Wound Care and Hyperbaric Center
Miamisburg, Ohio, 45342
Center for Clinical Research
San Francisco, California, 94115
About this study
An open, non-comparative, multicenter investigation to evaluate the safety and performance of Exufiber Ag+, a gelling fiber silver dressing, when used in medium to high exuding chronic wounds
Read the detailed description
The overall objective of this post market clinical follow-up (PMCF) investigation is to confirm performance and safety of the Exufiber Ag+ dressing in medium to high exuding chronic wounds, with Mepilex Border Flex as the secondary dressing, when used in accordance with the Instructions for Use.
- Conditions
- Pressure Ulcer, Diabetic Foot Ulcer, Venous Leg Ulcer
- Being tested
- ExufiberAG+
- Medical subject headings
- Pressure Ulcer, Diabetic Foot, Varicose Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExufiberAG+Device
confirm performance and safety of the Exufiber Ag+ dressing in medium to high exuding chronic wounds
| Study group | Role | What they receive |
|---|---|---|
| ExufiberAG+02 | Other | using ExufiberAG as the primary dressing on medium to high exuding chronic wounds. Receives: Device: ExufiberAG+ |
What is being measured
The primary outcome is the main question the study is designed to answer.
evaluate the safety and performance of Exufiber Ag+ in medium to high exuding chronic wounds
open, non-comparative, multicenter investigation
Measured: 28 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2022
- Study start1 Jan 2022
- Primary completion29 Nov 2022
- Study completion29 Nov 2022
Why it stopped: Sponsor decision secondary to data collection
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pressure UlcerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Molnlycke Health Care AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05494450
- Sponsor's protocol ID
- ExufiberAg+02
- Status last verified
- Apr 2023
- First submitted
- 8 Aug 2022
- Last updated
- 6 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open, Non-comparative, Multicenter Investigation to Evaluate the Safety and Performance of Exufiber Ag+, a Gelling Fiber Silver Dressing, When Used in Medium to High Exuding Chronic Wounds
- ClinicalTrials.gov ID
- NCT05494450
- Acronym / sponsor ID
- ExufiberAg+02
- Conditions
- Pressure Ulcer, Diabetic Foot Ulcer, Venous Leg Ulcer
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor decision secondary to data collection
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Molnlycke Health Care ABIndustry (pharma, biotech, devices)
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 29 Nov 2022 (actual)
- Study completion
- 29 Nov 2022 (actual)
- First posted
- 10 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
An open, non-comparative, multicenter investigation to evaluate the safety and performance of Exufiber Ag+, a gelling fiber silver dressing, when used in medium to high exuding chronic wounds
Detailed description
The overall objective of this post market clinical follow-up (PMCF) investigation is to confirm performance and safety of the Exufiber Ag+ dressing in medium to high exuding chronic wounds, with Mepilex Border Flex as the secondary dressing, when used in accordance with the Instructions for Use.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ExufiberAG+02 | Other | Device: ExufiberAG+using ExufiberAG as the primary dressing on medium to high exuding chronic wounds. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Signed Informed Consent Form
- Patient aged ≥18 years old
- Patient with moderate to high exuding chronic wound (PU (stage II-IV), VLU or DFU)
- Patient with target wound that is a shallow to deep wound or cavity
- Patient with target wound that is ≥ 4 weeks in age
Key exclusion criteria (13 listed)
- Patient is contraindicated for the dressing according to product labeling
- Known allergy/hypersensitivity to any of the components of the investigation products
- Pregnancy/lactating female
- Patient with spreading soft tissue infection/cellulitis in the wound (as judged by the Investigator)
- Patient with known immunodeficiency
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExufiberAG+confirm performance and safety of the Exufiber Ag+ dressing in medium to high exuding chronic wounds | Device | ExufiberAG+02 |
Primary outcome
evaluate the safety and performance of Exufiber Ag+ in medium to high exuding chronic wounds
Time frame: 28 Days
open, non-comparative, multicenter investigation
Results and safety
The study was stopped early (reason given: Sponsor decision secondary to data collection). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2023.
- Individual participant dataSharing planned: No
Related trials for Pressure Ulcer
RecruitingPhase 4
Clinical Trial Evaluating a Single Layer Amniotic Membrane and Standard of Care in the Management of Nonhealing Pressure Ulcers
Pressure Ulcer, Ulcer, Pressure
Not yet recruiting
Comparison of Negative Pressure Wound Therapy Versus Moist Wound Dressing in Diabetic Foot Ulcer Patients
Diabetic Foot Ulcer
Recruiting
Physical Therapy Wound Care Modalities in Patients With Spinal Cord Injury (SCI)
Spinal Cord Injuries, Pressure Injuries
Recruiting
Implementing a Decision Support Tool to Prevent Community-Acquired Pressure Injury in Spinal Cord Injury (SCI) in the Spinal Cord Injury Clinic
Spinal Cord Injury, Pressure Injury
Not yet recruitingObservational study
Explainable AI for Prospective Pressure Injury Staging
Pressure Injury
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ExufiberAG+ in people with Pressure Ulcer and Diabetic Foot Ulcer, run by Molnlycke Health Care AB at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Sponsor decision secondary to data collection). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
evaluate the safety and performance of Exufiber Ag+ in medium to high exuding chronic wounds (time frame: 28 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2023.