WoundsNCT02662218
Observational Study of Clinical Performance of a Sterile, Bacteria-binding, Super-absorbent Wound Dressing
An observational study of Wounds, run by BSN Medical GmbH at 1 site in United Kingdom.
Trial summary
This prospective, multicenter, single-arm observational study aims to document the clinical performance and safety of a sterile, bacteria-binding, super-absorbent wound dressing for the intended use in a daily clinical practice. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Wounds
- How many people
- 32 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jul 2016to Feb 2017
- Phase
- Observational
- 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
Study population: Patients with superficial wounds of any etiology, that are treated at outpatients' clinic
Who may be able to join
- Men and women ≥ 18 years old
- Written informed consent after patient education to participate in the study
- Superficial wounds of any etiology affecting only epidermis and dermis layers
- Maximum wound size: 6 x 16cm / 6 x 6cm
- Wounds with one or more clinical signs or infection or assessed as at high risk of infection according to the following:
- Wounds assessed as critically colonized with malodour, abnormal tissue or absence of viable tissue, excessive or increased serous exudate, possible extension of wound dimensions and no sign of a healing process and/or
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- Wounds with one or more historical episodes of topical infection and/or
- Wounds assessed as at a high risk of infection on other grounds by the investigator.
- Superficial wounds with high levels of exudate
Who cannot join
- Not willing to sign or incapable of signing an informed consent form
- Known allergy or sensitivity to one of the dressing components
- Pregnancy or lactation
- Subject is participating in another clinical study
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Welsh Wound Innovation Centre
Ynysmaerdy, Rhondda Cynon Taf, CF728UX
About this study
Official title: Prospective, Multicenter, Observational Study to Evaluate the Clinical Performance of a Sterile, Bacteria-binding, Super-absorbent Wound Dressing
This prospective, multicenter, single-arm observational study aims to document the clinical performance and safety of a sterile, bacteria-binding, super-absorbent wound dressing for the intended use in a daily clinical practice. 50 patients (male/female) with superficial wounds of any etiology affecting only epidermis and dermis layer, with one or more clinical signs of infection or at high risk of infection and also high to very high exudate levels will be observed over a period of 14 days.
- Conditions
- Wounds
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with superficial wounds | A cohort of 50 patients with superficial wounds of any etiology (see inclusion criteria), who need advanced wound care treatment in any case, will be observed over a period of 14 days; the exact duration for each patient depends upon the investigator's assessment. The observation consists of an initial visit, at least one dressing change after max. 7 days and a final visit. Patients will be treated with the CE-marked wound care product. This product is already in general use in the Netherlands and Germany. It is a sterile, bacteria-binding, super-absorbent wound dressing. Apart from the predefined study visits, daily dressing changes in accordance with daily clinical practice are possible. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with persisting infections will be documented in a standardized Case Report Form (CRF).
Symptoms such as odor, pain, localized heat and erythema will be assessed by a clinician and documented in four different categories depending on its severity.
Measured: 14 days
Number of participants with newly developed infections will be documented in a standardized Case Report Form (CRF)
Symptoms such as odor, pain, localized heat and erythema will be assessed by a clinician and documented in four different categories depending on its severity.
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2016 (estimated)
- Study startJul 2016
- Primary completionFeb 2017
- Study completionFeb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for WoundsStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- BSN Medical GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nicky Ivins, Principal investigator, Welsh Wound Innovation Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02662218
- Sponsor's protocol ID
- C1438
- Status last verified
- Jun 2017
- First submitted
- 8 Jan 2016
- Last updated
- 21 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Multicenter, Observational Study to Evaluate the Clinical Performance of a Sterile, Bacteria-binding, Super-absorbent Wound Dressing
- ClinicalTrials.gov ID
- NCT02662218
- Acronym / sponsor ID
- C1438
- Conditions
- Wounds
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- BSN Medical GmbHIndustry (pharma, biotech, devices)
- Study start
- Jul 2016 (actual)
- Primary completion
- Feb 2017 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 25 Jan 2016 (estimated)
- 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.
This prospective, multicenter, single-arm observational study aims to document the clinical performance and safety of a sterile, bacteria-binding, super-absorbent wound dressing for the intended use in a daily clinical practice. 50 patients (male/female) with superficial wounds of any etiology affecting only epidermis and dermis layer, with one or more clinical signs of infection or at high risk of infection and also high to very high exudate levels will be observed over a period of 14 days.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with superficial wounds | – | –A cohort of 50 patients with superficial wounds of any etiology (see inclusion criteria), who need advanced wound care treatment in any case, will be observed over a period of 14 days; the exact duration for each patient depends upon the investigator's assessment. The observation consists of an initial visit, at least one dressing change after max. 7 days and a final visit. Patients will be treated with the CE-marked wound care product. This product is already in general use in the Netherlands and Germany. It is a sterile, bacteria-binding, super-absorbent wound dressing. Apart from the predefined study visits, daily dressing changes in accordance with daily clinical practice are possible. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with superficial wounds of any etiology, that are treated at outpatients' clinic
Key inclusion criteria (9 listed)
- Men and women ≥ 18 years old
- Written informed consent after patient education to participate in the study
- Superficial wounds of any etiology affecting only epidermis and dermis layers
- Maximum wound size: 6 x 16cm / 6 x 6cm
- Wounds with one or more clinical signs or infection or assessed as at high risk of infection according to the following:
Key exclusion criteria (4 listed)
- Not willing to sign or incapable of signing an informed consent form
- Known allergy or sensitivity to one of the dressing components
- Pregnancy or lactation
- Subject is participating in another clinical study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of patients with persisting infections will be documented in a standardized Case Report Form (CRF).
Time frame: 14 days
Symptoms such as odor, pain, localized heat and erythema will be assessed by a clinician and documented in four different categories depending on its severity.
Number of participants with newly developed infections will be documented in a standardized Case Report Form (CRF)
Time frame: 14 days
Symptoms such as odor, pain, localized heat and erythema will be assessed by a clinician and documented in four different categories depending on its severity.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2017.
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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.
Nicky Ivins principal investigator
Welsh Wound Innovation Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Wounds, run by BSN Medical GmbH at 1 site in United Kingdom.
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 9 inclusion and 4 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: finished, as of the sponsor's last update on 21 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of patients with persisting infections will be documented in a standardized Case Report Form (CRF). (time frame: 14 days). The study lists 2 primary outcomes in all. 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 21 Jun 2017.