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Post-Market Clinical-Follow-Up Study of Suprasorb® C Collagen Wound Dressing (Suprasorb®C)

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ClinicalTrials.gov Identifier: NCT03444597
Recruitment Status : Completed
First Posted : February 23, 2018
Last Update Posted : February 19, 2020
Sponsor:
Information provided by (Responsible Party):
Lohmann & Rauscher

Brief Summary:
Post-Market Clinical-Follow-Up Study of Suprasorb® C collagen wound dressing

Condition or disease
Venous or Mixed Leg Ulcers

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

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Study Type : Observational
Actual Enrollment : 111 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Post-Market Clinical-Follow-Up Study of Suprasorb® C Collagen Wound Dressing
Actual Study Start Date : January 24, 2018
Actual Primary Completion Date : January 23, 2020
Actual Study Completion Date : January 23, 2020

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The patient population is patient with venous or mixed leg ulcers
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03444597


Locations
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France
RCTs
Lyon, France, 69002
Sponsors and Collaborators
Lohmann & Rauscher
Investigators
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Study Director: Daria TROFIMENKO Lohmann and Rauscher
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Responsible Party: Lohmann & Rauscher
ClinicalTrials.gov Identifier: NCT03444597    
Other Study ID Numbers: 2017-A02514-49
First Posted: February 23, 2018    Key Record Dates
Last Update Posted: February 19, 2020
Last Verified: February 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Leg Ulcer
Skin Ulcer
Skin Diseases