RCTs
Lyon, 69002, France
Completed
NCT Number: NCT03444597
Post-Market Clinical-Follow-Up Study of Suprasorb® C Collagen Wound Dressing
Post-Market Clinical-Follow-Up Study of Suprasorb® C collagen wound dressing
Completed
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Notify MeKey information
Conditions
Age range
18 year–85 year
Sex eligibility
All sexes
Study type
Observational
Primary location
About this study
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
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- 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
Exclusion criteria
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
Treatment and study plan
Primary outcomes
-
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
Secondary outcomes
-
Frequency and severity of adverse events
Time frame: Frequency and severity is assessed up to 8 weeks
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
Sponsors and collaborators
Lead sponsor
Lohmann & Rauscher
Industry
Registry information
Acronym: Suprasorb®C
Important dates
- Study start
- 2018
- Primary completion
- 2020
- Study completion
- 2020
- First posted
- Feb 23, 2018
- Registry last updated
- Feb 19, 2020
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.