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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

111 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-01-24

Study Completion Date

2020-01-23

Brief Summary

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

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Detailed Description

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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

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Venous or Mixed Leg Ulcers

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No