Venous or Mixed Leg UlcersSuprasorb®CNCT03444597
Post-Market Clinical-Follow-Up Study of Suprasorb® C Collagen Wound Dressing
An observational study of Venous or Mixed Leg Ulcers, run by Lohmann & Rauscher at 1 site in France.
Trial summary
Post-Market Clinical-Follow-Up Study of Suprasorb® C collagen wound dressing Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Venous or Mixed Leg Ulcers
- How many people
- 111 participants
- Where
- 1 siteFrance
- Study dates
- 24 Jan 2018to 23 Jan 2020
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The patient population is patient with venous or mixed leg ulcers
Who may be able to join
- Patient over 18 years of age and under 85 years of age
- Patient suffering from confirmed venous or mixed vascular leg ulcers
- Stagnating wound conditions, i.e. exudation phase > 2 months, not responding to traditional dressing and standard treatment (standard treatment is a clear definition and for venous ulcers compression should be included)
- Target ulcers between 2 cm and 10 cm in the largest diameter
- Written confirmation from the study nurse that the patient was informed, orally agreed to participate and to comply with study treatment and planned visits
Who cannot join
- Use of Suprasorb® C collagen wound dressing is contraindicated according to the current IFU:
- Clinically infected areas
- Presence of known allergies to one or several of its components.
- In addition following patients shall not be included into this study:
- Patient not covered by health insurance/social security
- Patient suffering serious life threatening disease
- Pregnant or breastfeeding women
- Minor patient, protected adult, person without liberty
Trial locations and contacts
1 site in 1 country.
About this study
Post-Market Clinical-Follow-Up Study of Suprasorb® C collagen wound dressing
Read the detailed description
Prospective, uncontrolled multi-center, observational cohort study. The objectives of the PMCF study are confirmation of the performance, and to collect additional safety data regarding expected adverse events and to detect potential unexpected adverse events associated with use of Suprasorb®C under the conditions of routine use.
Suprasorb® C collagen wound dressing is a certified medical device (manufacturer: Lohmann \& Rauscher International GmbH \& Co. KG). The product has been marketed in the EU since 1983 as Opragen® (medicinal product), since 1995 as the medical device Opraskin® and since 2001 under the name Suprasorb C (medical device).
Suprasorb® C is intended to be used as a wound dressing for the support of wound healing or wound area reduction.
Participating Centers: 40 study nurses will participate to the PMCF Study Duration: 24 months Cohort size: 110 patients Follow-up: 8 weeks
- Conditions
- Venous or Mixed Leg Ulcers
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression of healing after application of Suprasorb® C collagen wound dressing is used as parameter for performance evaluation
Progression of healing after application of Suprasorb® C collagen
Measured: Progression of healing is assessed at 8 weeks
Secondary outcomes (1)
Frequency and severity of adverse events
Frequency and severity of adverse events, incidences, as well as known risk and side effects, i.e. wound infection, side effects in the group of allergic disorders, pain, and maceration
Measured: Frequency and severity is assessed up to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2018
- Study start24 Jan 2018
- Primary completion23 Jan 2020
- Study completion23 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous or Mixed Leg UlcersStudies 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
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lohmann & Rauscher
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Daria TROFIMENKO, Study director, Lohmann and Rauscher
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03444597
- Sponsor's protocol ID
- 2017-A02514-49
- Acronym
- Suprasorb®C
- Status last verified
- Feb 2020
- First submitted
- 8 Feb 2018
- Last updated
- 19 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Market Clinical-Follow-Up Study of Suprasorb® C Collagen Wound Dressing
- ClinicalTrials.gov ID
- NCT03444597
- Acronym / sponsor ID
- Suprasorb®C / 2017-A02514-49
- Conditions
- Venous or Mixed Leg Ulcers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- Lohmann & RauscherIndustry (pharma, biotech, devices)
- Study start
- 24 Jan 2018 (actual)
- Primary completion
- 23 Jan 2020 (actual)
- Study completion
- 23 Jan 2020 (actual)
- First posted
- 23 Feb 2018 (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.
Post-Market Clinical-Follow-Up Study of Suprasorb® C collagen wound dressing
Detailed description
Prospective, uncontrolled multi-center, observational cohort study. The objectives of the PMCF study are confirmation of the performance, and to collect additional safety data regarding expected adverse events and to detect potential unexpected adverse events associated with use of Suprasorb®C under the conditions of routine use.
Suprasorb® C collagen wound dressing is a certified medical device (manufacturer: Lohmann \& Rauscher International GmbH \& Co. KG). The product has been marketed in the EU since 1983 as Opragen® (medicinal product), since 1995 as the medical device Opraskin® and since 2001 under the name Suprasorb C (medical device).
Suprasorb® C is intended to be used as a wound dressing for the support of wound healing or wound area reduction.
Participating Centers: 40 study nurses will participate to the PMCF Study Duration: 24 months Cohort size: 110 patients Follow-up: 8 weeks
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The patient population is patient with venous or mixed leg ulcers
Key inclusion criteria (5 listed)
- Patient over 18 years of age and under 85 years of age
- Patient suffering from confirmed venous or mixed vascular leg ulcers
- Stagnating wound conditions, i.e. exudation phase > 2 months, not responding to traditional dressing and standard treatment (standard treatment is a clear definition and for venous ulcers compression should be included)
- Target ulcers between 2 cm and 10 cm in the largest diameter
- Written confirmation from the study nurse that the patient was informed, orally agreed to participate and to comply with study treatment and planned visits
Key exclusion criteria (8 listed)
- Use of Suprasorb® C collagen wound dressing is contraindicated according to the current IFU:
- Clinically infected areas
- Presence of known allergies to one or several of its components.
- Patient not covered by health insurance/social security
- Patient suffering serious life threatening disease
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
Progression of healing after application of Suprasorb® C collagen wound dressing is used as parameter for performance evaluation
Time frame: Progression of healing is assessed at 8 weeks
Progression of healing after application of Suprasorb® C collagen
1 secondary outcome
Frequency and severity of adverse events
Time frame: Frequency and severity is assessed up to 8 weeks
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 19 Feb 2020.
Related trials for Venous or Mixed Leg Ulcers
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.
Daria TROFIMENKO study director
Lohmann and Rauscher
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 Venous or Mixed Leg Ulcers, run by Lohmann & Rauscher at 1 site in France.
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 5 inclusion and 8 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 19 Feb 2020. 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 France. 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?
Progression of healing after application of Suprasorb® C collagen wound dressing is used as parameter for performance evaluation (time frame: Progression of healing is assessed at 8 weeks). 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 19 Feb 2020.